Salient Features of IP-2010 (VI edition) - ipapharma.org - EDQM pdf/Raman Singh - whats ne… ·...

Salient Features of Salient Features of IPIP--2010 (VI edition)2010 (VI edition)

By:By:-- Dr. Raman Mohan SinghDr. Raman Mohan SinghPrincipal Scientific Officer,Principal Scientific Officer,

IPCIPC--IPL, Ghaziabad.IPL, Ghaziabad.Website: Website: www.ipc.gov.inwww.ipc.gov.inEmail: [email protected]: [email protected]

http://www.ipc.gov.in/

As per the Drugs and Cosmetics Act As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia is 1940, the Indian Pharmacopoeia is the legally recognized book of the legally recognized book of Standards for the quality of drug Standards for the quality of drug substances and preparations substances and preparations included therein. included therein.

This new edition of the Indian This new edition of the Indian Pharmacopoeia entitled Indian Pharmacopoeia entitled Indian Pharmacopoeia 2010 has been Pharmacopoeia 2010 has been prepared by the Indian prepared by the Indian Pharmacopoeia Commission (IPC) in Pharmacopoeia Commission (IPC) in accordance with a plan and completed accordance with a plan and completed through the untiring efforts of its through the untiring efforts of its members, Secretariat and Laboratory members, Secretariat and Laboratory over a period of about two years. over a period of about two years.

Introduction

This is the sixth edition of the This is the sixth edition of the Indian Pharmacopoeia after Indian Pharmacopoeia after Independence. Independence.

It supersedes the 2007 edition but It supersedes the 2007 edition but any monograph of the earlier any monograph of the earlier edition that does not figure in this edition that does not figure in this edition continues to be official as edition continues to be official as stipulated in the Second Schedule stipulated in the Second Schedule of the Drugs and Cosmetics Act, of the Drugs and Cosmetics Act, 1940. 1940.

Publication of IPEditionEdition Year Year I I 19551955II II 19661966III III 19851985IV IV 19961996

Addenda Addenda -- 200020002000 (Vet. Suppl)2000 (Vet. Suppl)2002200220052005

V V 20072007Addendum Addendum -- 20082008

VI New EditionVI New Edition-- 20102010

Published by : Published by : Indian Pharmacopoeia Commission, Indian Pharmacopoeia Commission, Ghaziabad.Ghaziabad.

Printed by Printed by : National Institute of Science : National Institute of Science Communication And Information Resources Communication And Information Resources (NISCAIR) near Pusa Gate, New Delhi.(NISCAIR) near Pusa Gate, New Delhi.

Publication and Printing

Presentation of IP 2010

IP 2010 is presented in three volumes IP 2010 is presented in three volumes with the following features:with the following features:

Volume 1Volume 1Volume 2Volume 2Volume 3Volume 3

Content of Volume I

•• NoticesNotices

•• PrefacePreface

•• Indian Pharmacopoeia CommissionIndian Pharmacopoeia Commission

•• AcknowledgementsAcknowledgements

•• IntroductionIntroduction

•• General ChaptersGeneral Chaptersoo General NoticesGeneral Noticesoo Test MethodsTest Methodsoo ApparatusApparatus

oo Biological MethodsBiological Methodsoo Chemical MethodsChemical Methodsoo Physical and Physicochemical MethodsPhysical and Physicochemical Methodsoo Pharmaceutical MethodsPharmaceutical Methodsoo Tests on Herbal ProductsTests on Herbal Productsoo Tests on VaccinesTests on Vaccinesoo Tests on Blood and BloodTests on Blood and Blood--related Productsrelated Productsoo Reference DataReference Dataoo Reagents and SolutionsReagents and Solutionsoo General TestsGeneral Testsoo ContainersContainersoo TablesTables

Content of Volume II

•• General NoticesGeneral Notices

•• General Monographs on Dosage General Monographs on Dosage FormsForms

•• Monographs on Drug substances, Monographs on Drug substances, Dosage forms and Pharmaceutical Dosage forms and Pharmaceutical Aids Monographs A to MAids Monographs A to M

Content of Volume III•• General NoticesGeneral Notices•• Monographs on Drug substances, Dosage Monographs on Drug substances, Dosage

forms and Pharmaceutical aids forms and Pharmaceutical aids Monographs N to ZMonographs N to Z

•• Monographs on Vaccines and Monographs on Vaccines and Immunosera for Human UseImmunosera for Human Use

•• Monographs on Herbs and Herbal Monographs on Herbs and Herbal ProductsProducts

•• Monographs on Blood and BloodMonographs on Blood and Blood--related related ProductsProducts

•• Monographs on Biotechnology ProductsMonographs on Biotechnology Products•• Monographs on Veterinary ProductsMonographs on Veterinary Products

oo NonNon--BiologicalBiologicaloo BiologicalBiologicaloo DiagnosticsDiagnostics

•• IndexIndex

•• New DrugsNew DrugsAPIAPI’’ssFormulationsFormulations

•• Anticancer drugsAnticancer drugs•• ExcipientsExcipients•• Vaccines and OtherVaccines and Other•• Biological ProductsBiological Products•• Herbal ProductsHerbal Products

NEW EDITION

Specific featuresAdding:Adding:

(i) New monographs.(i) New monographs.

(ii) Category, Dose and Usual Strengths.(ii) Category, Dose and Usual Strengths.

(iii) General Chapter on Liposomal (iii) General Chapter on Liposomal Preparations.Preparations.

(iv) Appendices on NMR.(iv) Appendices on NMR.

(v) New Herbs and Herbal monographs.(v) New Herbs and Herbal monographs.

(vi) Excipient monographs.Excipient monographs.

(vii) Anticancer monographs.(vii) Anticancer monographs.

(viii) Adopted for latest drug delivery (viii) Adopted for latest drug delivery system (i.e. Amphotericin B Injection).system (i.e. Amphotericin B Injection).

(ix) Drugs not in use are omitted from this (ix) Drugs not in use are omitted from this edition.edition.

The scope of the Pharmacopoeia has The scope of the Pharmacopoeia has been extended to include products of been extended to include products of biotechnology, indigenous herbs and biotechnology, indigenous herbs and herbal products, Veterinary vaccines herbal products, Veterinary vaccines and additional antiretroviral drugs and and additional antiretroviral drugs and formulations, inclusive of commonly formulations, inclusive of commonly used fixedused fixed--dose combinations.dose combinations.

Standards for new drugs and drugs Standards for new drugs and drugs used under National Health used under National Health Programmes are added in this edition Programmes are added in this edition and drugs as well as their formulations and drugs as well as their formulations not in use now a days are omitted from not in use now a days are omitted from this edition.this edition.

GNSGNS--IPCIPC--GZBGZB 1616

The number of monographs of Excipients, The number of monographs of Excipients, Anticancer drugs, Herbal products and Anticancer drugs, Herbal products and Anti HIV drugs have been increased in Anti HIV drugs have been increased in this edition. this edition.

Monographs of Vaccines and Monographs of Vaccines and Immunosera are also upgraded in view of Immunosera are also upgraded in view of latest technology in the field. latest technology in the field.

A new chapter on Liposomal products A new chapter on Liposomal products and a monograph of Liposomal and a monograph of Liposomal Amphotericin B injection is an added Amphotericin B injection is an added advantage in veiw of latest technology advantage in veiw of latest technology adopted for drug delivery.adopted for drug delivery.


A chapter on NMR is also incorporated A chapter on NMR is also incorporated in Appendices. in Appendices.

The chapter on microbial The chapter on microbial contamination is also updated to great contamination is also updated to great extent to harmonize with prevailing extent to harmonize with prevailing international scenario.international scenario.

FormatIn an effort to make the pharmacopoeia In an effort to make the pharmacopoeia more usermore user--friendly, design of the texts of friendly, design of the texts of the monographs and of the test methods the monographs and of the test methods are kept same however they are are kept same however they are upgraded.upgraded.

CrossCross--referencing has been avoided to referencing has been avoided to make each monograph complete in itself make each monograph complete in itself thus making it convenient to the analyst thus making it convenient to the analyst performing the tests and to the ones performing the tests and to the ones checking the results of analysis.checking the results of analysis.


Basis of Pharmacopoeial requirement

As in the past, this compendium provides a As in the past, this compendium provides a publicly available statement concerning the publicly available statement concerning the quality of a product that can be expected quality of a product that can be expected and demonstrated at any time throughout and demonstrated at any time throughout the accepted shelfthe accepted shelf--life of the article. life of the article.

The standards laid down represent the The standards laid down represent the minimum with which the article must minimum with which the article must comply and it is incumbent on the comply and it is incumbent on the manufacturer to ensure that the article is manufacturer to ensure that the article is manufactured in accordance with Good manufactured in accordance with Good Manufacturing Practices (GMPs). Manufacturing Practices (GMPs).


It is essential that sufficiently stringent It is essential that sufficiently stringent limits are applied at the time of release of a limits are applied at the time of release of a batch of a material or product so that the batch of a material or product so that the pharmacopoeial standards are met until its pharmacopoeial standards are met until its expiry date under the storage conditions expiry date under the storage conditions specified.specified.

It must be noted that a valid interpretation It must be noted that a valid interpretation of any requirement of the Pharmacopoeia of any requirement of the Pharmacopoeia should be done in the context of the should be done in the context of the monograph as a whole, the relevant monograph as a whole, the relevant general monograph, where appropriate, general monograph, where appropriate, the specified tests and methods of analysis the specified tests and methods of analysis including any reference to the relevant including any reference to the relevant General NoticesGeneral Notices.

Familiarity with the General Notices Familiarity with the General Notices will facilitate the correct application of will facilitate the correct application of the requirements.the requirements.


Keeping in view the essential requirement Keeping in view the essential requirement under the Drugs and Cosmetics Act, 1940 under the Drugs and Cosmetics Act, 1940 and Rules there in the information on and Rules there in the information on category of a drug, dosage and usual category of a drug, dosage and usual available strengths of dosage forms has been available strengths of dosage forms has been rere--kept in this edition.kept in this edition.

General chemical tests for identification of an General chemical tests for identification of an article have been almost eliminated and the article have been almost eliminated and the more specific infrared and ultraviolet more specific infrared and ultraviolet spectrophotometric tests have been given spectrophotometric tests have been given emphasis. The concept of relying on emphasis. The concept of relying on published infrared spectra as a basis for published infrared spectra as a basis for identification has been continued. identification has been continued.


ChangesChanges

The use of chromatographic methods has The use of chromatographic methods has been greatly extended to cope with the been greatly extended to cope with the need for more specificity in assays and in need for more specificity in assays and in particular, in assessing the nature and particular, in assessing the nature and extent of impurities in ingredients and extent of impurities in ingredients and products. products.

Most of existing Assays and Related Most of existing Assays and Related substances tests are upgraded by liquid substances tests are upgraded by liquid chromatographic method in view to chromatographic method in view to harmonize with other international harmonize with other international Pharmacopoeias.Pharmacopoeias.


The test for pyrogens involving the use of The test for pyrogens involving the use of animals has been virtually eliminated.animals has been virtually eliminated.

The test for bacterial endotoxins The test for bacterial endotoxins introduced in the previous editions is now introduced in the previous editions is now applicable to more items. applicable to more items.

The test for abnormal toxicity is now The test for abnormal toxicity is now confined to certain vaccines.confined to certain vaccines.


General ChaptersVolume I is devoted mainly to test Volume I is devoted mainly to test methods that are applicable to all the methods that are applicable to all the articles of the pharmacopoeia and articles of the pharmacopoeia and general information pertaining to the general information pertaining to the quality requirements of medicinal quality requirements of medicinal substances.substances.

It also includes reference data such as It also includes reference data such as reference spectra, typical chromatograms reference spectra, typical chromatograms etc. etc.


The test methods reflect the sophistication of The test methods reflect the sophistication of analytical methodology and instrumentation.analytical methodology and instrumentation.

Analytical methods are in general in harmony Analytical methods are in general in harmony with those adopted internationally for with those adopted internationally for monitoring the quality of drugs. monitoring the quality of drugs.

The steps taken for harmonization have been The steps taken for harmonization have been initiated by the need to cope with the increasing initiated by the need to cope with the increasing demand for drugs manufactured in the country demand for drugs manufactured in the country to globally accepted standardsto globally accepted standards.


The trend towards controlling the The trend towards controlling the microbial quality of all medicinal products microbial quality of all medicinal products has been recognized and the requirement has been recognized and the requirement regarding limits of bacterial contamination regarding limits of bacterial contamination even of products for oral administration even of products for oral administration and topical application so that adequate and topical application so that adequate controls are exercised by manufacturers controls are exercised by manufacturers by the adoption of GMPs has been by the adoption of GMPs has been continued.continued.


General Monographs

The General Monographs for dosage The General Monographs for dosage forms of active pharmaceutical forms of active pharmaceutical ingredients (APIs) are grouped ingredients (APIs) are grouped together at the beginning of Volume II. together at the beginning of Volume II.

They are followed by the monographs They are followed by the monographs for the APIs, pharmaceutical aids and for the APIs, pharmaceutical aids and individual dosage forms, all in individual dosage forms, all in alphabetical order. Monographs for alphabetical order. Monographs for other articles of a specialother articles of a special


nature such as vaccines and nature such as vaccines and immunosera for human use, herbs and immunosera for human use, herbs and herbal products, blood and blood herbal products, blood and blood related products, biotechnology related products, biotechnology products and veterinary products are products and veterinary products are given in separate sections in Volume given in separate sections in Volume III.III.

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