INDIAN PHARMACOPOEIA 2007 PDF
A pad of cotton wool G is placed on 23 INDIAN PHARMACOPOEIA BIOLOGICAL METHODS AbnormalToxicity 25 IP INDIAN PHARMACOPOEIA CONTENTS. Monographs on Drug Substances, Dosage Forms and Pharmaceutical Aids. Monographs to Z . Monographs. The full name or title of this book, including addenda thereto, is Indian Pharmacopoeia , abbreviated to IP In the texts, the term “ Pharmacopoeia” or.
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Pharmacopoeia can be amended and the Secretary-cum- v IP PREFACE Preface The Indian Pharmacopoeia is published by the Indian technology. Legal Notices. In India, under the Drugs and Cosmetics Act , the current edition of Indian Pharmacopoeia is a book of standards for. an evidence-based guide is organised into four sections day to guide their clinical practice Herbs and Natural Suppleme.
Sixth Edition 6. Krishnan Marg, New Delhi Price per set: Legal Notices Scientific Director is authorised to issue such amendments. Whenever such amendments are issued, the Indian In India, under the Drugs and Cosmetics Act , the current Pharmacopoeia would be deemed to have been amended edition of Indian Pharmacopoeia is a book of standards for accordingly.
Unichem Mr. Central Drugs valuable and enthusiastic assistance in preparing this edition. The scientific inputs by way of the co"operation and co- New Delhi. Chandru Sahani of Clenzaids for time to time is noteworthy. Arbro Pharmaceutical Ltd. Bee is a source of immense inspiration and in his personal capacity Pharma Laboratories. Indian Immunological Ltd. Davinder Kapoor. Ranbaxy Research motivated one and a. Pharmacopoeia Laboratory.
Organisation of Dr NityaAnand. The Commission expresses its gratitude to Mr.. Special mention is being made of the permission granted at the time ofpreparing the preceding edition by the Controller ofHer The Commission wishes to record its deep appreciation of the Majesty's Stationery Office HMSO. Central Drugs Testing Laboratory. Ghaziabad from reference materials the United States Pharmacopoeia. Central Research Institute. Mumbai and the Indian Central Drugs The Commission is greatly indebted to the members of the Laboratory.
Cipla Ltd. Brahrni and Mr. Joint Secretary HR and Mr. Arbro Pharmaceuticals Ltd. Kaushal Kishore.
Torrent Research Centre. Ahmedabad and the Panda. These include the Indian Pharmacopoeia Laboratory. Hindustan Unilever Ltd. Kapoor along with his associate Mr. Natural Remedies Pvt. Shiv Kumar Marhkan. Baxter India Pvt. At the same time. Secretary R for their interest shown on this publication. All India Institute of Medical Sciences.
Special thanks to Dr. Infra-red Reference Spectra ofother particularly Mr. Conventions and other gratefully acknowledged. Supriya Gupta. Scientific Body.. Sanjeev way attributable to any of the publications mentioned above Garg under overa.. The Indian Commission. Debasish Bangalore. Indian Veterinary Research Institute. Anticancer drugs. General of the Pharmacopoeia should be done in the context of the Monographs on Dosage Forms.
The test for pyrogens involving the use of animals has been virtually eliminated. It is essential that sufficiently stringent limits are applied at the time ofrelease of Presentation a batch of a drug substance or drug product so that the The Indian Pharmacopoeia is presented in three volumes. Herbal products and identification has been continued. Volume II contains the General Notice. A and in particular. Monographs on drug monograph as a whole. Most of the Liposomal Amphotericin B injection is an added advantage in existing Assays and Related substances tests are upgraded view of latest technology adopted for drug delivery.
A by liquid chromatography method in view to have more chapter on NMR is incorporated in Appendices. The number of monographs of concept of relying on published infrared spectra as a basis for Excipients. The test for bacterialendotoxins introduced in the previous edition is now applicable to more Fonnat items.
Biotechnology products and Veterinary products. Standards for new drugs and drugs used General chemical tests for identification of an article have been under National Health Programmes are added and the almost eliminated and the more specific infrared and ultraviolet drugs as well as their formulations not in use nowadays are spectrophotometric tests have been given emphasis. Changes The scope of the Pharmacopoeia has been extended to include Keeping in view the essential requirement under the Drugs products of biotechnology.
The use of chromatographic methods has been greatly Monographs of Vaccines and Immunosera are also upgraded extended to cope with the need for more specificity in assays in view of development of latest technology in the field. Herbs and Herbal products. This new edition of the Indian Pharmacopoeia entitled 6th Basis of Pharmacopoeial Requirements edition Indian Pharmacopoeia is published by the Indian As in the past.
The specificity and to harmonise with other International chapter on microbial contamination is also updated to a Pharmacopoeias. Antiretroviral drugs have been increased in this edition. The omitted from this edition. The standards laid down It supersedes the edition but any monograph of the earlier represent the minimum with which the article must comply edition that does not figure in this edition continues to be and it is inculcate on the manufacturer to ensure that the official as stipulated in the Second Schedule of the Drugs and article is manufactured in accordance with the Good Cosmetics Act.
Cross-referencing has been avoided to make General Chapters each monograph complete in itself thus making it convenient Volume I is devoted mainly to test methods that are applicable to the analyst. Blood and blood-related products. The test for abnormal toxicity is now confined to certain In an effort to make the pharmacopoeia more user-friendly.
Manufacturing Practices GMPs. Clindamycin Capsules xviii. Bifonazole Cream dosage forms. Betamethasone Lotion In view of considering the microbiological quality. Anastrozole Tablets The chapter on Vaccines: General requirements has been Anhydrous Lactose updated. For the fIrst time in this chapter BumetanideInjection the analysis of strain Shigella boydii has been introduced Bumetanide Oral solution which is possibly not available in other Pharmacopoeias.
Analytical methods are. Monographs for other Chymotrypsin articles of a special nature such as vaccines and irnmunosera for human use. Special emphasis has been given on Capecitabine Tablets monoclonal antibodies Antisera. Calcium Chloride Injection The chapter on biotechnology derived therapeutic products Capecitabine has been fully revised.
Wherever appropriate. Tests for extraneous agents Atazanavir Capsules in seed lot. A list of new monographs items not included in the It also includes reference data such as reference spectra.
Minor corrections have been made in the appendices Artesunate entitled Tests onChicken flocks free from specified pathogens for the production and quality control of vaccines and General Atazanavir Sulphate provisions: Avian viral vaccines. The test methods reflect the but added in this edition is given below: Monographs on drug substances.
Homatropine MetIlylbrofuide 1ablets"". Live xx. Powder for Inhalation Secnidazole Diphtheria. Pertussis Whole Cell. Live Sulphadimidine Omissions. Aclmowledgements xv Introduction xvii General Chapters 7 5. Tests on Blood and Blood-related Products 3. General Tests 6. General Notices 9 2.
Tests on Vaccines 2. Pharmaceutical Methods 2. Biological Methods 25 2. Physical and Physicochemical Methods 2. Containers 7. Tables 7. Reference Data 4. Test Methods 17 2. Chemical Methods 69 2. Reagents and Solutions 5.
INDIAN PHARMACOPOEIA VOL.1.pdf
Apparatus 19 2. Tests on Herbal Products 2. All statements to it by the manufacturer. IP 1. The freedom to the manufacturers to add auxiliary used in this Pharmacopoeia or with reference thereto. Automated An official preparation is a drug product dosageform and is procedures utilising the same basic chemistry as the test the finished or partially finished preparation or product of one procedures given in the monograph may also be used to or more official substances formulated for use on the patient.
The word 'official' wherever organisms. General Statements excipients pharmaceutical aids. An article is an item for which a monograph is provided.
An official substance. Particular care should be taken to ensure that such substances are free from harmful Official and Official Articles.
In the event of doubt or dispute. Such mention to the contrary. Such alternative or automated procedures must be validated. The active pharmaceutical ingredients drug substances. The designation IP in conjunction with the the innocuity of such substances. The full name or title of this book. An article responsibility for assigning the period of validity shall be is not of pharmacopoeial quality unless it complies with all of with the manufacturer. The requirements stated in the obtained by the procedure given in this Pharmacopoeia is monographs apply to articles that are intended for medicinal conclusive.
Alternative methods of analysis monographs are provided are to be distinguished. The tests and assays described are the article purports to comply with IP standards. Added Substances. FresWy prepared. Such an upper limit applies to the suitable desiccant. The term "alcohol" without qualification means ethanol 95 per cent. Unless otherwise stated. The term 'distilled water' indicates Purified Water prepared by Usually.
Other methods of heating may be final solution. Relative Density. The following expressions in issued for' use. The term 'distilled water' When the concentration of a solution is expressedas. Iodine Value. The water used complies the number of inmilitres of substance in grams of with the requirements of the monograph on Purified Water.
Where the name of the solvent is not stated. Where the content of a substance is solution. For example. Where the result of an assay or test is required to be calculated Ethanol. Not more than. Other dilutions of ethanol are indicated final product.
A tightly-closed container of suitable size and Where the content of a substance is expressed in terms of the design that maintains an atmosphere of low moisture content chemical formula for that substance an upper limit exceeding by means of silica gel or phosphorus pentoxideor other per cent may be stated.
The symbol '0' used without qualification as percentage volume in volume. Made not more than 24 hours before it is Expression of Concentrations. Abbreviated Statements. Two consecutive 'contains not less than If the tenn is used without qualification it means Purified Water of the Pharmacopoeia. A bath of boiling water unless water at another as parts by weight g ofa' gas in parts by weight g of the temperature is indicated.
Any printed packing material. The term "ethanol" without qu! Pification means with reference to the dried. A quantity not exceeding 0. When the concentration of a solution is expressed in molarity designated by the symbol M preceded by a number..
The main titles of drug products are the ones commonly except where a preamble limits the application. The opening statement of a monograph is one monographs for those individual ingredients for which that constitutes an official definition of the substance. The atomic weight or than those included in the statement. Any ingredient s other Atomic and Molecular Weights. The opening definitive incorporated in a trivial name that appears on an IUPAC statement in certain monographs for drug products is given in preferred list.
It is for the licensing authority to statement of purity and strength and in descriptions of verify that the instructions have been followed.
Synonyms drawn from the full non- requirements are not necessarily comprehensive for a given proprietary name of the active ingredient or ingredients have specific preparation. Subsidiary names and synonyms have also been General monographs on dosage forms include requirements given in some cases.
Monographs Titles. The stereochemistry. Statements given under the heading Production is based on the full name of the active ingredient. This information refers to the either on selected batches or on each batch prior to release. When the chemical structure ofan official for example. Chemical Fonnulae.
Where the absolute stereochemical configuration is specified. All measures are not interfere with the tests and assays of the Pharmacopoeia. Graduated glass apparatus used in analytical Individual Monographs operations shall comply with the requirements stated in Chapter 2. An apply equally to veterinary products as well. The recognised in practice. The atomic and the Pharmacopoeial requirements. The metric system of weights and in the therapeutic efficacy of the active ingredients and shall measures is employed in the Pharmacopoeia.
Any substance added in preparing an official specified are the applicable limits. Certain pharmaceutical substances and other articles are defined by reference to a particular method ofmanufacture. Doses mentioned in the Pharmacopoeia are intended spectrum should be achieved.
It generally are given. The statements under the heading Description exposure to direct sunlight or other strong light. A Test Methods statement that a substance or article is prepared or obtained by a certain method constitutes part of the official defInition References to general methods of testing are indicated by test and implies that other methods are not permitted.
Assurance of quality must be preparation given in the individual monograph indicates the ensured by the manufacturer by the use of statistically valid strength s usually marketed for information of the pharmacist sampling and testing programmes. Where a are not to be interpreted. In certain monographs for pharmaceutical Solubility. In the case of found is incompatible with gOQd pharmaceutical practice.
In the case of When tests for infrared absorption are applied to material pharmaceutical aids it may indicate the more common usage extracted from formulated preparations. The statement of category is provided for information and is indicative of the medical or pharmaceutical. A statement method numbers in brackets immediately after the heading of that a substance may be prepared or obtained by a. The limits of content stated are those identity. The statement is not intended to limit in any way with the specifIed reference spectrum may not always be the choice or use of the article nor to indicate that it has no possible.
The tests and assays are the official methods upon which the They are not to be regarded as binding upon the prescribers. In monographs on vegetable drugs. Statements on solubility are given in Chapter 2. It does not imply that a strength other than the one s mentioned in the individual monograph Tests. Tests and assays are prescribed for the minimum sample available on which the attributes of the Usual Strength.
If it is usual to administer a Material found to contain such an impurity is not of drug by a method other than by mouth. In certain monographs alternative series ofidentifIcation tests basis for recognition in the Pharmacopoeia. The requirements The medical practitioner will exercise his own judgment and are not framed to take into account all possible impurities.
They provide a means of verifying that the identity determined by the method described under Assay. The statement on the usual strength s of a article should be measured. It is act on his own responsibility in respect of the amount of any not to be presumed. The tests given under the heading IdentifIcation and does not imply that other methods are not permissible.
The reagents required for the tests in terms of the active ingredient. Where it is directed to use a Limits. Volumes stated in microlitres are measured using a micropipette Reference spectra are published by the IPC and they are or microsyringe. They are standardized against after the decimal point is a zero or ends in a zero. Certain monographs require the use under examination. The flask or a burette. In the monographs on dosage forms and certain monographs in the pharmacopoeia shall not be claimed to be preparations.
The limits given are based on data obtained in normal 'general laboratory reagent grade of commerce' it is intended analytical practice. Reagents standards to be used in cases of arbitration. Standards Working Standards may be used for routine analysis. This means that the quantity and assays of the Pharmacopoeia are defined in the various of the active ingredient expected to be present and the quantity chapters showing their nature.
They are the official conditions. No further be used. For the measurement of volumes. For preparations other than those of fixed strength. The stated on the label. Unless otherwise directed. Secondary are used in the prescribed amounts. Test Animals. For weighings. A specification for a definite size or type that will interfere with the test or the assay. Where the use of an indicator solution is mentioned requirements of the monograph. In tests where IP Reference Substances. The amount actually for intended use as prescribed in the Pharmacopoeia and are used.
Details The term 'analytical reagent grade of commerce' implies that of such tests are provided in the general monographs. Measuring and weighing devices and other test or an assay shall be healthy and are drawn from a uniform apparatus are described in the chapter entitled 'Apparatus for stock. They take into account normal analytical that a chemically pure grade material. In determining compliance with a a recommendation. Statements under the side-heading Storage constitute Storage Containers.
The In certain cases. Do not freeze governed by the Drugs and Cosmetics Rules. The articles of the Pharmacopoeia are the chapter entitled Containers 6. Precautions that should be In general. The requirements. For the following terms: Tests on Blood and Blood-related Products Gas Detector Tubes 21 2. Nessler Cylinders 21 2. Thermometers 22 2. Continuous Extraction of Drugs 23 Ultraviolet Ray Lamps 22 2.
Sieves 22 2. Weights and Balances 23 2. Volumetric Glassware 22 2. The overall height is about mm. They contain reagents adsorbed onto inert cited in the leaflet.
The minimum value indicated is 0. They comply with IS Fig. Gas Detector Tubes In view of the wide variety of available compressor oils. Sealed glass tube containing volume of the gas under examination through the tube. Information on the reactivity for various oils is an inert transparent material and constructed to allow the given in the leaflet supplied with the tube. IP 2. If the oil used is not passage of gas.
Connect the flexible tubing fitted with a Y- piece to the valve and adjust the flow of gas under examination Carbon monoxide detector tube: Sealed glass tube containing to purge the tubing to an appropriate flow see Fig.
The minimum value indicated is 67 ppm or less. The calibration of the detector tubes is verified according to The minimum value indicated is 0. The minimum value indicated is 1 ppm or less. Sulphur dioxide detector tube: Sealed glass tube containing adsorbent filters and suitable supports for the iodine and starch The test is carried out by passing the required volume of the indicator.
The external height to the ml 3. Prepare the indicator tube and fit to the metering pump following selenium dioxide and fuming sulphuric acid indicators. Water vapour detector tube: They are of transparent glass with a nominal capacity of 50 ml.
Apparatus for Gas Detector Tubes Nessler Cylinders 6 Nessler cylinders which are used for comparative tests are matched tubes of clear. Connect the open end of the minimum value indicated is 5 ppm or less. Operating conditions Nitrogen monoxide and nitrogen dioxide detector tube: Sealed Examine according to the manufacturer's instructions or glass tube containing adsorbent filters and suitable supports proceed as follows: Read adsorbent filters and suitable supports for an appropriate lead the value corresponding to the length of the coloured layer or salt indicator.
The the manufacturer's instructions. Sealed glass tube containing substances that interfere with the substance to be detected. Oil detector tube: Sealed glass tube containing adsorbent filters and suitable supports for the sulphuric acid indicator. Theremust be no reaction between the material used.
The The distance 60 37 13 9. The lamp should be capable of revealing without doubt a standard spot of sodium salicylate with a diameter of 16 41 1. JIIl G. Sieves conform to the specifications given in Table 1. Volumetric apparatus must be suitably designed to assure accuracy. Sieves They may be standardised fortotal immersion odor partial immersion.
The thermometers are of the mercury-in-glass burettes. Table 1 2. The discrepancy is inconsequential 34 45 4. Examine 44 38 13 the spot in a position normal to the radiation.
Class pharmacopoeial tests conform to Indian Standard Volumetric Glassware 35 90 6. The wires are of uniform circular is essential to consider the conditions under which it is to be cross-section. In theselection ofa thermometer. For this purpose the following test may be carried out. Class A is and are standardised in accordance with the Indian Standard intended for use in work of the highest accuracy. There are two grades Unless otherwise specified.
Method of Calibrating Liquid-in-Glass tolerances on capacity for volumetric flasks. Thermometers volumetric glassware should be in accordance with those laid down by the Bureau of Indian Standards.
The design. To the extent possible. Where the monograph prescribes viewing under ultra-violet light of 4 55 4. Table 2 Class 1. IS They are available in various denominations from 1 to mg.
The tolerance for any Nominal 5 10 25 50 denomination in this class is 5 Ilg. Class A 0. They may be used for weighing accurately One-Mark Pipettes: Nominal 1 2 5 10 20 25 50 Class 2 weights are used at working standards for calibration, capacity, ml built-in weights for analytical balances, and laboratory weights forroutine analytical work.
Continuous Extraction ofDrugs Nominal capacity, ml 1 2 5 10 25 Subdivision, ml 0. Any Class B 0. The type commonly known as the Nominal capacity, ml 10 25 50 soxhlet apparatus is suitable for this purpose. Subdivision, ml 0. Where it is directed that a quantity be 'accurately measured', A the apparatus must be chosen and used with care.
A burette should be of such size that the titrant volume represents not less than 30 per cent of the nominal volume. Where less than lOml of titrant is to be measured, a lO-ml microburette is generally required. Weights and Balances Pharmacopoeial assays and tests require the use of analytical balances that vary in capacity, sensitivity and reproducibility.
The accuracy needed for a weighing indicates the type of balance. Where substances are to be 'accurately weighed', the weighing is to be performed so as to limit the error to not more than 0.
For example, a quantity of 50 mg is to be weighed so that the error does not exceed 0. Abalance should be chosen such that the value of three times the standard deviation ofthe reproducibility ofthe balance, divided Fig. Apparatus for continuous extraction of Drugs by the amount to be weighed, does not exceed 0. A is an outer tube standard weights.
The substance to be extracted, cm in length and has an external diameter of about 1. A pad of cotton wool G is placed on the top of material. D is a glass coil, which supports the margin of the the drug, the inner tube is lowered into position and outer tube B and prevents it from resting in contact with the outer tube connected by means of a suitable cork with the tube of a tube A.
The lower end C of the outer tube A is fitted by a cork reflux condenser F. The flask is heated and the extraction to the distilling flask E, in which a suitable quantity of the continued as directed. Abnormal Toxicity 27 2. Effectiveness ofAntimicrobial Preservatives 27 2. Bacterial Endotoxins 28 2. Depressor Substances 33 2. Haemolysins 35 2. Histamine 35 2. Pyrogens 36 2. Microbial Contamination in Nonsterile Products 37 2. Microbiological Assay ofAntibiotics 49 2.
Sterility 56 2. Thiomersal 63 2. Urinary Excretion ofDextrans 64 2. Immunochemical Methods 64 2. Host-cell and Vector-derived DNA 66 2. Limes flocculationis Lt Abnormal Toxicity metabolic by-products may cause adverse reactions in sensitized persons.
General test. Inject intravenously into each of five healthy Any antimicrobial agent may show the protective properties mice, weighing 17 g to 22 g, the quantity of the substance of a preservative.
However, for the protection of the consumer under examination in 0. If more than one animal dies, the preparation fails dose parenteral, otic, nasal, opthalmic, oral and topical the test. If one of the animals dies, repeat the test. The products made with aqueous bases or vehicles, the substance passes the test if none of the animals in the second effectiveness of any added preservatives, dming the shelf- group die.
Unless otherwise prescribed in the has not been impaired by storage. The tests apply only to the individual monograph inject intra-peritoneally one human dose product in the Oliginal, unopened container in which it was but not more than 1. The container with a prescribed inoculum of suitable human dose is that stated on the label or in the accompanying microorganisms, storing the inoculated product at a prescribed information leaflet of the preparation under examination. If samples removed.
The preservative properties of the product more than one animal dies, the preparation fails the test. If one are considered adequate if, in the conditions of the test, there of the animals die or show signs of ill health, repeat the test.
The organisms specified for use in the tests are intended to be representative of those that might be expected to be found in the environment in which the preparation is manufactured, 2. Effectiveness ofAntimicrobial stored and used. However, they should be supplemented by Preservatives other strains or species, especially those likely to be found in the conditions under a particular product is made or used, or NOTE-The test for effectiveness of antimicrobial that might offer a particular challenge to the type of product preservatives shall be demonstrated during development of being tested.
Single strain challenges rather than mixed pharmaceutical preparation and during the commercial cultures should be used throughout. The test is not intended to be usedfor routine Precautions. Challenge tests should be conducted under control purpose. The primary purpose of adding Test organisms.
The following test organisms are used in the antimicrobial preservatives to dosage forms is to prevent test. However, antimicrobial agents should not be used solely to reduce. NCYC ; preparations that are not required to be sterile. It should be IP In order to prevent any phenotypic changes in the strains are not more than 10 per cent of the initial concentration used, the organisms used in the test should not be more than at 7 day and not more than 0.
One passage is concentration at 14 day and there is a further decrease in defined as inoculation and growth of the organisms from count at 28 day.
NOTE- All the media used in the tests should be tested for ii For topical preparations made with aqueous base, non- growth promotion. Grow each of the bacterial species applied to mucous membrane: After incubation, harvest the growth count. To bacteria are not more than 10 per cent of the initial suspend spores of Aspergillus niger 0.
Use suspension of these in count at 28 day. The suspension may be stored at mold count at 14 and 28 days from the initial count.
Remove immediately a suitable sample from each suspension 2. Bacterial Endotoxins and determine the number of cfu per ml. This value serves The test for bacterial endotoxins BET measures the to determine the inoculum concentration and the baseline to concentration of bacterial endotoxins that may be present in use in the test.
If sufficient volume atleast 20 ml of product is the horseshoe crab, Limulus polyphemus. Other species of available in each container and the product container can be horseshoe crab namely Tachypleus gigas, Tachypleus inoculated aseptically then the test can be conducted in five tridentatus and Carcinoscropius rotundicauda also yield original containers of the product. If filled volume is less, or amoebocyte lysate having similar activity. Inoculate each container with one of the prepared of the lysate produces turbidity, precipitation or gelation of and standardized inoculum in such a way that after inoculation the mixture.
However, addition of a chromogenic substrate to the fmal concentration of the organisms remains between 1x10 5 a solution of the lysate results in development of colour due and lx cfu per ml and the volume of the inoculum does not to release of chromophore from the substrate upon activation exceed 1per cent of the volume of the product. The initial by the endotoxin present in the solution. The rate of reaction concentration of the viable organisms in each test preparation depends on the concentration of endotoxin, the pH and the is estimated based on the concentration of the microorganisms temperature.
The reaction requires the presence of certain in each of the standardized inoculum as determined by the bivalent cations, a clotting cascade enzyme system and pour plate method or membrane filtration method. Incubate the inoculated containers at room temperature. The following methods can be used to monitor the endotoxin Determine the viable count by plate-count method at 7, 14, concentration in a product official in the Pharmacopoeia and and 28 days subsequent to the inoculation.
Record any to determine whether the product complies with the limit changes observed in the appearance at these intervals. From specified in the monograph. Semi-quantitative Gel-Clot Method for each organism at the stated test intervals and express the changes in terms of percentage of initial concentration.
Method C. Kinetic Turbidimetric Method Method D. Kinetic Chromogenic Method Interpretation. The preservatives are considered to be effective if: Method E. End-Point Chromogenic Method i For parenteral, ophthalmic, sterile nasal and otic When a monograph includes a test for bacterial endotoxins without preparations: IF 2.
Anyone of the other four methods may be employed as an not less than 30 seconds before proceeding to make the next alternative method provided it yields results of equivalent dilution. With the adoption of the second endotoxin testing. International Standard for endotoxin by the Expert Committee Lysate. Tachypleus tridentatus or CarcinoscOlpius rotundicauda The endotoxin limit for a given test preparation is calculated reconstituted as stated on the label.
The species from which from the expression KIM, where M is the maximum dose the lysate is obtained is stated on the label. Water that gives a negative result under the kg per hour. The value of K is 5. It may be prepared by 0. The test should be carried out in a manner that avoids microbial contamination. If necessary, the containers should be treated 0. Prepare from hydrochloric acid to eliminate surface endotoxins that may be present by heating using water BET. Mter adjustment of the pH 6.
Before carrying out the test for endotoxins in the preparation 0. Prepare from sodium hydi-oxide under examination it is necessary to velify using water BET. Mter adjustment of the pH to 6. Dissolve 0. It gives a negative result under the conditions of the enhance the reaction or otherwise interfere with the test test. Endotoxin reference standard and controlstandard endotoxin. Gel-Clot Methods The Endotoxin Reference Standard ERS is the freeze-dried, Methods A and B depend on the formation of a firm gel when purified endotoxin of Escherichia coli, which is calibrated in a solution containing bacterial endotoxins is incubated after Endotoxin Units ED by compalison with the International mixing with the lysate.
Method A is conducted as a limit test Standard.
INDIAN PHARMACOPOEIA 2007 Volume 2
Method B determines the endotoxin clot or other suitable method is maintained by Indian concentration semiquantitatively in the preparation under Pharmacopoeia Commission, Ghaziabad.
The freeze-dried endotoxin should be reconstituted with water Sensitivity of the lysate. Confirm the labelled sensitivity of BET by mixing intermittently for 30 minutes using a vortex each new batch of lysate prior to use in the test using at least mixer. The concentrate should be stored in a refrigerator for one vial of each batch of lysate. Prepare a sedes of dilutions not more than 28 days. Subsequent dilutions of the of CSE to give concentrations of 21, 1, 0.
Perform the than 3 minutes before use. Each dilution should be mixed for test as given under Method on these four standard. At least the final dilution in each MVD test solution. Carry out the following procedure in receptacles where,: At intervals that This average gives the estimated lysate sensitivity which must will permit the reading of each result, add to each receptacle lie between 0.
The possibility of interference single test vials are used. Mix the sample-lysate mixture gently with the bacterial endotoxins test by certain factors should be and place in an incubating device such as a water-bath or a borne in mind. For validation of the test results it must be heating block, accurately recording the time at which the demonstrated that the test preparation does not inhibit or receptacles are so placed.
Remove the receptacles and validation must be repeated if the lysate vendor or the method examine the contents carefully. A positive reaction is of manufacture or the formulation of the sample is changed.
A negative result is The allowable dilution level or Maximum Valid Dilution MVD characterised by the absence of such a gel or by the formation is dependent on the concentration of the product, the of a viscous gel that does not maintain its integrity. Record endotoxin limit for the product and the lysate sensitivity. It is such a result as negative -.
Handle the receptacles with care calculated by the following expression: Prepare replicates of solutions b the results obtained with solutions of series C confirm A to D as indicated in the table. Solution Final concentration of added Number of c the geometric mean of the end-point concentration of CSE in the solution replicates solutions of series B is not more than 21 or not less than 0.
A 4 B 21 4 If the result obtained is outside the specified limit, the test preparation under examination is acting as an inhibitor or 0. The interfering factors may be eliminated by further 0. The 1 2 use of a more sensitive lysate permits the use of greater dilution 0.
Carry out the procedure on the test solutions in as asymmetrical membrane fIlters of cellulose triacetate. Such duplicate as described under Test for interfering factors. To calculate the causing false positive results. The material retained on the endotoxin concentration in the product, determine for the fIlter, which contains the endotoxins, is rinsed with water BET series of test solutions the lowest concentration or the highest or tris-chloride buffer pH 7.
Multiply this dilution recovered in the water BET or the buffer. The endotoxin factor with '. For instance, if MVD is equal to 8 and the positive reaction Establish that the chosen treatment effectively eliminates was obtained at 0. If none of the dilutions of the series gives a positive reaction, the endotoxin concentration will be less than the value MethodA.
Gel-Clot Limit Test Method obtained by multiplying the lowest dilution factor with '. If all Preparation of test solutions. Unless otherwise prescribed, the dilutions of the series give a positiv! If endotoxin concentration will be more than the value obtained necessary, adjust the pH of the solution under examination to by multiplying the highest dilution factor with '.
The product BET. Carry out the procedure on the test solutions in Kinetic Chromogenic Method Method D and duplicate as described under Test for interfering factors. Interpretation of results. The product under examination complies with the bacterial endotoxin test if the positive These methods make use of a linear regression of the log product control is positive and the negative control as well as response with the log endotoxin concentration.
The test is not valid if the To ascertain the precision or validity of the turbidimetric and positive product control is negative or if the negative control chromogenic methods, preparatory tests are conducted to is positive.
The kinetic turbidimetric method is a photometric assay Retests. If a positive result is found for one ofthe test solution measuring the increase in turbidity caused by the reaction of duplicates and a negative result for the other, the test may be the endotoxin with the lysate. The kinetic turbidimetric assay repeated as described above. The results of the retest should is a method measuring either the time onset time needed to be interpreted as for the initial test.
Method B. Semi-Quantitative Gel-Clot Method The kinetic chromogenic method is a photometric assay Preparation of test solutions. Prepare test solutions at measuring the colour developed by the chromophore released concentrations of MVD, 0. The kinetic chromogenic assay is a method for interfering factors was completed. Additionally, prepare a measuring either the time onset time needed to reach a similar series of test solutions spiked with 2'.
The end-point chromogenic method is a photometric assay Calculation and interpretation of results. Calculate the measuring, the colour developed by the chromophore released endotoxin concentration of solutions A and B from the from a chromogenic substrate by the reaction of the endotoxin regression equation obtained with solutions of seriesC.
The end-point assay is a method measuring Calculate the mean perc'entage recovery of the added the colour intensity at the end of an incubation period after endotoxin by subtracting the mean endotoxin concentration the reaction is stopped by the addition of a suitable acid. Preparation of the standard curve. Using CSE, prepare solutions of not less than three endotoxin concentrations to The test for interfering factors is valid only if obtain a linear standard curve.
Carry out the procedure using a the negative control solution D does not yield a value at least two replicates of each standard endotoxin solution in higher than the limit for the value required in the accordance with the instructions of the lysate manufacturer description of the lysate employed; volume ratios, incubation times, temperature, pH, etc. For validation of the test results, solution B is between 50 per cent and per cent. The validation must be repeated if the lysate vendor or the the interfering factors must be removed by the procedure method of manufacture or formulation of the sample is described under the Gel-Clot Method.
The initial dilution may be prepared using the following expression: Kinetic Turbidimetric Method. If necessary, adjust the pH of the solution under examination to 6. Use not less the initial dilution test solution. Use water BET as negative control and one positive concentration at or near the middle of the control. The positive control consists of the test solution standard curve PPC. The pH of the solutions must be in the range specified by the Interpretation of results. The assay is valid only if manufacturer of the lysate, usually between 6.
Adjust a the standard curve is linear for the range of CSE the pH, if necessary, by addition of sterile 0. Carry out the test in duplicate receptacles such as the positive product control is between 50 per cent and wells of a micro-titre plate. Into each chosen receptacle, add per cent.
Add the lysate and carry out the assay test if the mean endotoxin content of the replicates, after in accordance with the instructions given by the lysate correction for dilution and concentration, is less than the manufacturer. Unless otherwise prescribed, Use a healthy, adult cat, either male or non-pregnant female, prepare the solutions to be employed in the test using water weighing not less than 2 kg.
Weigh the cat and anaesthetise it BET. If necessary, adjust the pH of the solution under by intraperitoneal injection of an anaesthetic substance such examination to 6. Immobilize the animal, protect it with water BET. Introduce a Prepare the test solution at a suitable dilution.
INDIAN PHARMACOPOEIA VOL.1.pdf | Pharmaceutical Drug | Herbalism
Prepare a tube into the trachea. Expose a carotid or other suitable artery, reagent blank and not less than three dilutions of CSE in water separate it from surrounding tissues, insert a cannula fIlled BET to prepare a linear standard curve.
Use water BET as with heparinised saline solution and connect to a device negative control and one positive control. The positive control capable of recording the blood pressure continuously.
Then consists of the test solution spiked with CSE to give an expose a femoral vein and insert another cannula filled with endotoxin concentration at the middle or below the middle heparinised saline solution to facilitate intravenous injection point of the standard curve PPC.
Carry out the procedure described under Test for examination. Iyer M. Member Mr. Sipahimalani C,Ananta, R. Member Dr. Gachibowli Post Hyderabad Prem K.
Prafull D. Nayak President, Tech. Operations Watson Pharma Pvt. Member ProfessorY. Invitee Mr. Invitee Dr. Sheth, Mr. Iyer and Dr. Chandrashekhar Chair , Dr. Thomas, Mr. Antony Raj Gomes, Dr. Raghuveer, Dr. Pramod Dalvi, Dr. Manish Gangrade.
Amarjit Singh, Mr. Satyawan Hatte. RamaRao Chair ,Dr. Anil Paul Kariath Chair , Mr. Ganesh Kumaraj, Mr. Kotbagi, Dr. Rustom Mody, Dr. Venkata Ramana. Gupta Chair ,Mr. Zareen Bharucha, Dr. Kabita Chatterjee, Mr. Atul Kr. Gupta Chair , Dr. Anoop Misra, Professor P. Rama Rao, Dr. Rama Mukherjee, Dr. Parthajyoti Gogoi Chair , ProfessorY. Madhusudan Rao, Dr. Prakash V. Diwan, Dr. Ramkishan, Dr.
Sweety Prem Kumar. Expert Committee on Devices and Diagnostics Dr. Bhuvaneshwar, Sh. Kapoor Chair ,Dr. Agrawal, Dr. Thomas, Dr. Milind Joshi. Sheth Chair , Mr.
Thakore, Dr. Shailesh Nagarsenker, ProfessorY. Madhusudan Rao, Mr. Iyer Chair. Anantha Narayana Chair , Dr. Handa, Dr. Lavekar, Dr. Lal, Dr. Katiyar, Dr. MVenkateswarlu Chair ,Dr. Pabrai,ProfessorSaranjit Singh. Pabrai Chair , Dr.
Singh, Dr. Murugesan, Dr. Chakraborti, Dr. Ashok Panwar. Kapoor Chair , Professor Meenakshi Bajpai. Prashant Dikshit, Ms V. ExpertCommitteeonParenteralProducts Dr. Shrotriya Chair , Mr. Sanjit Singh Lamba, Dr. Sumant Baukhandi, Mr. Bedi, Mr. Kisan B. Chaudhari, Professor Roop K. Khar, Dr. Praful R.
Hemnalini Kumar Chair , Mr. Parthajyoti Gogoi, Dr. Anantha Narayana, Mr. Daara B. Patel, Dr. Sanjay Singh. Srinivasan Chair , Dr. Tahlan, Dr. Surinder Singh, Dr. Rishendra Verma, Dr. Raman Mohan Singh Head , Dr. Mathur, Mr. Dinesh Kr. Sharma, Mr. Pawan Kr. Saini, Mr. Munendra Kr. Poonia and Km. Anu Somvanshi. Jai Prakash Head , Mr. Surendra Kr. Talwar, Mr.
Charan Singh Nivoria, Mr. Alok Sharma, Mr. Manoj Kr. Pandey and Mr. Satyapal Singh. Publication Division The issues related to publication, sales and marketing is looked after by following: Singh Head , Mr. Udai Pal and Mr. Sudhakar Singh. Scientific,Administrative and Miscellaneous Support Support provided in Scientific andAdministrative matters by following is appreciable: Savita Shukala, Ms.
Sangeeta Bhatnagar and Mr. Satyaprakash Tyagi Mr. Saxena, Mr. Tribhuvan Nautiyal, Mr. Oberoi and Mr. OtherParticipants Participants other than those mentioned above who assisted in the work relating to preparation of this Pharmacopoeia are given below: Abraham Patani, Dr.
Singh, Mr. Arvind Kukrety, Dr. Ram Krishan, Mrs. Annie Pillai, Mr. Arun Mendiratta, Mr. Arun Khosla, Mr. Atul Kumar Sharma, Ms.
Ayesha Patial, Dr. Koteeswaran, Mr. Atma Kuri, Mr. Alok Upadhyaya, Mr. Alok Kumar Yadav, Ms. Aarti Sharma, Dr. Anil Thakan, Mr. Anil Rana, Mr. Ashish Pargaonkar, Ms.
Ashwini Oza, Dr. Anil Kanaujia, Mr. Ashish Suthar, Mr. Anand S. Mayachari, Mr. Gayatri, Dr. Tiwari, Dr. Bhaswat Chaudhary, Mr. Rao, Mr.
Venugopal, Mr. Bhupendra Shah, Dr. Gupta, Ms. Prathima, Ms. Venkateswara Rao, Dr. Charles Rupprecht, Mr. Dattahari Dash, Mr. Deep Chandra Upadhyaya, Mr. Sood, Dr. Roy, Dr. Ghosh, Mr. Jain, Mr. Shringi, Mr. Devender Berthwal, Mr. Deepak Mhasawade, Mr. Deepak Sharma, Mr.
Dharmendra Kumar Pandey, Dr. Ferguson, Dr. Kamraj, Dr. Gajendra Singh, Mrs. Geetanjali, Mr. Prabhakar Roa, Dr. George Patani, Dr.
Dhamdhere, Dr. Reddy, Dr. Girish Sahni, Dr. Gyanesh Shukla, Dr. Trimurtulu, Dr. Bagchi, Dr. MeerAzad, Mr. HarjeetAggarwal, Dr. Hau-Pong, Ms. Ishani Kapila, Mr. Mathur, Dr. Janardan Singh, Dr. Jitendra Kumar, Dr. John Furesz, Dr. John Petricciani, Dr. Jen Ron- Chiang, Dr. Joachim Hombach, Mr. Bhargava, Dr. Mani, Dr. Reddy, Mr. Prasanna, Dr. Ananda Rao, Dr. Koprowski, Mr. Kishan B. Chaudhary, Dr. Jogi, Dr. Kiran M. Brdee, Dr.
Rajendra, Mr. Madan Mohan Prasad, Mrs. Madhu Bala Kapoor, Dr. Manoj Patel, Dr. Rajani, Mr. Suryanarayana, Dr. Gupta, Dr. Murali, Mr. Asif, Ms. Nita Kejrewal, Dr. Gopalan, Mr. Niranjan S. Kanaki, Ms. Neelam Tarani, Mr. Naresh Soni, Mr. Om Prakash, Dr. Kanitkar, Mr. Praful Lahorkar, Dr.
Praveen Tiwari, Ms. Premlata, Dr. Pele Chong, Ms. Lakshmi, Dr. Rao, Sh. Raghunandan, Dr. Rahul Singh, Mr. Rajendra M. Dobriyal, Mr. Yjuurvedi, Mr. Bhakuni, Mr. Ramesh Dhar, Mrs. Ritu Tiwari, Dr. Rajashree Rane, Mrs. Rashmi Srivastava, Dr.
Singh, Pofessor R. Khosa, Mr. Kanna Babu, Mr. Shantanu Chobhe, Mr. Supratika Tripathi, Mr. Sanjay Kumar, Mr. Bharuch, Mr. Shishir Jaipuria, Mr. Sacchidananad, Dr. Natarajan, Dr. Suresh Kumar, Dr.
Sheetal Anandjiwala, Dr. Sushma Srivastava, Professor S. Agarwal, Dr. Khanuja, Dr. Sunil Gairola, Dr. Desai, Dr. ScottHalstead, Mr.
Malik, Mr. Sanjeev Kumar, Mr. Sanjeev Verma, Mr. Sunil Goel, Mr. Shib Nath Nanergei, Dr. Shrenik Gangwal, Dr.
Shri Prakash, Ms. Sujata Sen, Ms. Shweta Gulati, Mr. Sanjay Srivastava, Mr. Sanjiv Kumar, Dr. Sangeeta Bhaskar, Mr. Satish Kulkarni, Dr. Santosh Ghadge, Dr. Shankar Chinchkar, Professor S. ShivrajYadav, Dr. SanjeevWadhwa, Mrs. Subhra Samadtar, Mr. Thakur Sher Singh, Dr. Vyas, Mr. Vikas Dogar, Mr. Vikas Chhawchharia, Mr. Vivek Bansal, Mr. Vivek Jadav, Mr. Vivek Dhariwal, Mr.
Vijay Kshrisagar, Ms. Veenu Tyagi, Mr. Phatak, Dr. Vinayak Naik, Ms. VandanaAneja, Mr. Rathore, Dr. Udaya Bhaskar Rao, Mr. Yogesh Biradar. At the same time, the Commission wishes to state that if any errors have inadvertently crept into the present compilation with regard to the statements of quantities or strengths or making quotations, such mistakes are in no way attributable to any of the publications mentioned above or to the authorities issuing them.
Close co-operation has continued with specialists from many organisations in India and abroad. The cooperation extended by the United States Pharmacopoeia Convention, USA, the British Pharmacopoeia Commission and the industry in incorporating new features in this edition is gratefully acknowledged.
The structural formulae of the organic molecules forming the subject matter of the monographs of all drug substances were drawn with the facility provided by NIPER, Mohali.
Professor V K Kapoor along with his associate Mr Gaurav Sharma and Dr Nitya Anand have been entirely responsible for ensuring the accuracy of the structures and the chemical names; the Commission acknowledges their valuable contribution in this respect. The Commission is greatly indebted to the members of the Scientific Body and the various experts in the industry for their valuable and enthusiastic assistance in preparing this edition.
The scientific inputs from them and the co-operation and co-ordination of a high order among them is deeply appreciated The Commission is especially indebted to three individuals who must be named because without their combined dedication, diligence and sense of public service, this enterprise would not have been completed in the limited time that was available.
Mr J L Sipahimalani, Ms V R Menon and Mr R S Iyer with their professional knowledge, inputs and meticulous attention to detail reviewed all the monographs and general chapters and put the manuscripts into their present new shape. Thanks are due to them for shouldering the major responsibility of preparing this edition Dr Nitya Anand, Chairman, IP Commission was a source of immense inspiration and in his personal capacity motivated one and all in their efforts to give of their best to the creation of this compendium.
The Commission is grateful to him. Secretarial assistance of a high order was provided by IPC Secretarial staff, special mention is the devotion to duty exhibited by Dr.
Raman Mohan Singh, Dr. Sharma and Mr. Saini in the work of careful scrutiny, review and correction of the manuscripts at various stages. In particular, Mr. Munendra Kumar Poonia as the Computer Assistant Secretarial with IPC rendered valuable service in typing and formatting of each and every monograph, the appendices and other texts.
The Commission records its appreciation of his contribution. The facility provided by Mr. Pradeep Banarjee, Mr. Kaushal Kishore, Smt. Supriya Gupta, Mr. Nagpal, Mr. Pankaj Gupta, Mr. Shiv Kumar and Mr. Sehgal in bringing out this publication.
This is the fifth edition of the Indian Pharmacopoeia after Independence. It supersedes the edition but any monograph of the earlier edition that does not figure in this edition continues to be official as stipulated in the Second Schedule of the Drugs and CosmeticsAct, Presentation The Indian Pharmacopoeia is presented in three volumes. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, viral vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations.
Standards for veterinary drugs and products that were published as a Supplement to the previous edition of the Indian Pharmacopoeia now form an integral part of this compendium. Format In an effort to make the pharmacopoeia more user-friendly, a drastic change has been made in the design of the texts of the monographs and of the test methods. Cross-referencing has been avoided to make each monograph complete in itself thus making it convenient to the analyst performing the tests and to the ones checking the results of analyses.
The multiplicity of fonts in the texts that was a feature of earlier editions has been done away with making it easier to read the contents and ensuring uniformity of presentation of the subject matter. Basis of Pharmacopoeial Requirements As in the past, this compendium provides a publicly available statement concerning the quality of a product that can be expected and demonstrated at any time throughout the accepted shelf-life of the article.
The standards laid down represent the minimum with which the article must comply and it is incumbent on the manufacturer to ensure that the article is manufactured in accordance with Good Manufacturing Practices.
It is essential that sufficiently stringent limits are applied at the time of release of a batch of a material or product so that the pharmacopoeial standards are met until its expiry date under the storage conditions specified.
It must be noted that a valid interpretation of any requirement of the Pharmacopoeia should be done in the context of the monograph as a whole, the relevant general monograph, where appropriate, the specified tests and methods of analysis including any reference to the relevant General Notices.
Familiarity with the General Notices will facilitate the correct application of the requirements. Changes Keeping in view the essential nature of the pharmacopoeia as a compilation of drug quality standards and test methods for determining compliance with such standards, information on category of a drug, dosage and usual available strengths of dosage forms has been omitted. Solubility, which has either to been included in the informatory section of a monograph, is now a part of a section listing the solubilities of all active pharmaceutical ingredients and pharmaceutical aids.
This information has been given only as an aid for the additional characterization of an article and not as a standard. As further simplification of labelling of medicines, the main titles for monographs of formulated preparations are given in the shorter form in terms of the active moiety rather than of the salt with few exceptions.
Labelling and storage are featured at the end of a monograph more as recommendations than as requirements except where a specific label statement is necessary for an analyst to determine compliance or a storage condition is essential for preserving the quality of an article. Classical chemical tests for identification of an article have been almost eliminated and the more specific infrared and ultraviolet spectrophotometric tests have been given.
The concept of relying on published infrared spectra as a basis for identification has been continued. The use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products. The test for pyrogens involving the use of test animals has been virtually eliminated. The test for bacterial endotoxins introduced in the previous edition is now applicable to more The test for abnormal toxicity is now confined to certain vaccines.
General Chapters Volume 1 is devoted mainly to test methods that are applicable to all the articles of the pharmacopoeia and general information pertaining to the quality requirements of medicinal substances. It also includes reference data such as reference spectra, typical chromatograms etc. The test methods reflect the sophistication of analytical methodology and instrumentation. Analytical methods are in general in harmony with those adopted internationally for monitoring the quality of drugs.
The steps taken for harmonization have been initiated by the need to cope with the increasing demand for drugs manufactured in the country to globally accepted standards. A vastly enlarged section on Containers for pharmaceutical products is an indication of the widespread use of plastics as the material of choice for packaging.
The evaluation of different types of plastics has been dealt with in some detail. The trend towards controlling the microbial quality of all medicinal products has been recognized and a start has been made to apply limits of bacterial contamination even of products for oral administration and topical application so that adequate controls are exercised by manufacturers by the adoption of good manufacturing practices.
General Monographs The General Monographs for dosage forms of active pharmaceutical ingredients APIs are grouped together at the beginning of Volume 2. They are followed by the monographs for theAPIs, pharmaceutical aids and individual dosage forms, all in alphabetical order. Monographs for other articles of a special nature such as vaccines and immunosera for human use, herbs and herbal products, blood and blood related products, biotechnology products and veterinary products are given in separate sections in Volume 3.
A list of items not included in the edition of the Indian Pharmacopoeia and its addenda but added in this edition is given below: General Monographs on Dosage Forms Monographs on Herbs and Herbal Products Monographs on Blood and Blood-related Products Monographs onVeterinary Products Test Methods Chemical Methods Tests on Herbal Products Tests onVaccines Tests on Blood and Blood-related Products Added Substances ProvisionsApplicable to Monographs andTest Methods Weights and Measures Tests andAssay Other tests A monograph is to be constructed in accordance with any general monograph or notice or any appendix, note or other explanatory material that is contained in this Pharmacopoeia and that is applicable to that monograph.
All statements contained in the monograph, except where a specific general notice indicates otherwise and with the exceptions given hereafter, constitute standards for the official articles. An article is not of pharmacopoeial quality unless it complies with all of the requirements stated.
Exceptions to the General Notices do exist, and where they do, the wording in the individual monograph or an appendix takes precedence and specifically indicates directions or the intent. Thus, the specific wording of standards, tests, assays and other specifications is binding wherever deviations from the General Notices exist.
Likewise, where there is no specific mention to the contrary, the General Notices apply. The full name or title of this book, including addenda thereto, is Indian Pharmacopoeia , abbreviated to IP Official and Official Articles. The designation IP in conjunction with the official title on the label of an article is an indication that the article purports to comply with IP standards. The following terms are used where the articles for which monographs are provided are to be distinguished.
An official substance is a single drug or a drug entity or a pharmaceutical aid for which the monograph title includes no indication of the nature of a dosage form.
An official preparation is a drug product dosage form and is the finished or partially finished preparation or product of one or more official substances formulated for use on the patient. An article is an item for which a monograph is provided, whether an official substance or an official preparation.
Official Standards. The requirements stated in the monographs apply to articles that are intended for medicinal use but not necessarily to articles that may be sold under the same name for other purposes. The active pharmaceutical ingredients drug substances , excipients pharmaceutical aids , pharmaceutical preparations dosage forms and other articles described in the monographs are intended for human and veterinary use unless explicitly restricted to one of these uses.
The requirements given in the monographs are not framed to provide against all possible impurities, contaminants or adulterants; they provide appropriate limitation of potential impurities only.
A preparation must comply throughout the shelf-life assigned to it by the manufacturer; for opened or broached containers the maximum period of validity for use may sometimes be stated in the individual monograph.
Nevertheless, the responsibility for assigning the period of validity shall be with the manufacturer. Added Substances. An official substance, as distinguished from an official preparation, contains no added substances exceptwhenspecificallypermittedintheindividualmonograph.
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