This new edition (Indian Pharmacopoeia 2010) is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a plan and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about two years. It supersedes the 2007 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 Cosmetics Act, 1940.

Presentation

The Indian Pharmacopoeia 2010 is presented in three volumes. Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction, and the General Chapters. Volume II contains the General Notice, General Monographs on Dosage Forms, Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume ill contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by Monographs on Vaccines and Immunosera for Human use,

Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary products. The scope of the Pharmacopoeia has been extended to include

products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use nowadays are omitted from this edition. The number of monographs of Excipients, Anticancer drugs, Herbal products and Antiretroviral drugs have been increased in this edition. Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. A chapter on NMR is incorporated in Appendices. The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international .requirements.

Changes

Keeping in view the essential requirement under the Drugs and Cosmetics Act, 1940 and Rules thereunder in the information on category of a drug, dosage and usual available strengths of dosage forms has been re-kept in this edition. General chemical tests for identification of an article have been almost eliminated and the more specific infrared and ultraviolet spectrophotometric tests have been given emphasis. 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 drug substances and drug products. Most of the existing Assays and Related substances tests are upgraded by liquid chromatography method in view to have more specificity and to harmonise with other International Pharmacopoeias. The test for pyrogens involving the use of animals has been virtually eliminated. The test for bacterial endotoxins introduced in the previous edition is now applicable to more items. The test for abnormal toxicity is now confined to certain vaccines.

VOLUME-I

VOLUME-II

VOLUME-III