Indian Pharmacopoeia, by India. Ministry of Health and Family Welfare, , Controller of Publications edition, in English. Get this from a library! Indian pharmacopoeia, [India. Ministry of Health and Family Welfare.;] -- Describes standards for drugs manufactured in India. Results 1 - 11 of 11 Indian Pharmacopoeia Addendum by Government of India-Ministry of Health & Family Welfare and a great selection of related.

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Indian Pharmacopoeia 1996 Pdf

intervals is one of the main mandates of the Commission. increase in the range of drugs produced in India, the IP , Indian Pharmacopoeia contains. The Indian Pharmacopoeia commission has a three-tier policy No of Monographs. IP. Indian pharmacopoeia click here 0B98jvpPl-VK-NVdTS1NxaC00bU0/edit?pli=1&docId=0B98jvpPl-VK-.

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. Also, in several other laws of India, the Indian Pharmacopoeia is recognised as the Patents and Trade Marks standard book. It is expedient that enquiry be made in each case in order to ensure that the provisions of any such law are In the Indian Pharmacopoeia, certain drugs and preparations being complied with.

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Print book: National government publication: English View all editions and formats Summary: Describes standards for drugs manufactured in India. Includes dosage forms, assay and test procedures, and packaging, storage and labelling instructions. Supplement contains information on veterinary drugs. Allow this favorite library to be seen by others Keep this favorite library private.

Find a copy in the library Finding libraries that hold this item Pharmacopoeia Additional Physical Format: Online version: Indian pharmacopoeia, Government publication, National government publication Document Type: Includes index.

A-O -- v. P-Z, appendices -- v. Veterinary supplement -- Addendum -- Addendum Reviews User-contributed reviews Add a review and share your thoughts with other readers. Be the first. Add a review and share your thoughts with other readers.

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Pharmacy Books: Indian Pharmacopoeia ()

Pharmacopoeia ofJapan. Malkhan Singh in successfully Laboratories. Acknowledgements In preparing the sixth edition of the Indian Pharmacopoeia Ma. Nitya Anand have put or to the authorities issuing them.

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.

Indian pharmacopoeia, 1996

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.

Welcome to the British Pharmacopoeia

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. 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. 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.


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