Indian Pharmacopoeia or simply Ip pharmacopoeia is another massive book in the series of Pharmacopoeia. The 6th edition of the Indian Pharmacopoeia 2010 is being published on schedule by the Indian Pharmacopoeia Commission (IPC) and, thanks to the tireless efforts of its members, secretariat and laboratory, will be completed over a period of around two years. It replaces the 2007 edition, but any monograph from the previous edition that is not included in this edition remains official, as set out in the second list of the Medicines and Cosmetics Act of 1940. This edition would come into effect on September 1, 2010.
|Name of Book||Indian Pharmacopoeia|
8190343661, 8190343696 Indian Pharmacopoeia Commission
|Volume||1 to 3|
The Indian Pharmacopoeia 2010 is presented in three volumes. Volume I contains the communications, the foreword, the structure of the IPC, acknowledgements, the introduction and the general chapters. Volume II contains the general announcement, general monographs on dosage forms, monographs on medicinal substances, dosage forms and pharmaceutical auxiliaries (A to M). Volume III contains monographs on drugs, dosage forms and pharmaceutical auxiliaries (N to Z), followed by monographs on vaccines and immunosera for human use, herbs and herbal products, blood and blood-related products, biotechnological products and veterinary products.
The scope of pharmacopoeia has been expanded to include biotechnology products, indigenous herbs and herbal products, veterinary vaccines, and additional antiretroviral drugs and formulations, including commonly used fixed-dose combinations. Standards for new drugs and drugs used in national health programs are added, and drugs and their formulations that are no longer used today are omitted from this edition. The number of monographs on excipients, cancer drugs, herbal products and antiretroviral drugs has been increased in this issue. Vaccine and Immunosera monographs are also updated to reflect the development of the latest technology in the field. A new chapter on liposomal products and a monograph on liposomal amphotericin B injection is an added benefit in view of the latest technology used for drug delivery. A chapter on NMR is included in the appendices. The chapter on microbial contamination is also largely adapted to the applicable international requirements.
10th Edition of IP:
In addition, emphasis was placed on harmonizing the appendices in order to create a solid connection between the individual monographs and the corresponding appendices in order to make this edition precise and well structured. The number of monographs and appendices continues to expand to reflect the latest technological advances and regulatory compliance. Continuous efforts have been made to unify National Pharmaceutical Standards and gradually bring them into line with International Standards by adding monographs of new medicines and adopting the current methodology.
This is the sixth edition of the Indian Pharmacopoeia. It consists of three volumes. Each band has different functions.
Hints; Preface; Via the Indian Pharmacopoeia Commission; Acknowledgments; Introduction; General chapters and reference data.
General information; Dosage forms (general monographs); Drugs, dosage forms and pharmaceutical auxiliaries (A to M).
General information; Medicinal substances, dosage forms and pharmaceutical auxiliaries (N to Z); Vaccines and immunosera for human use; Herbs and herbal products; ; Blood and blood related products; Biotechnology products; Veterinary products and index.
The standards prescribed in the Indian Pharmacopoeia are intended to determine compliance with regulatory requirements for an article. The criteria to be observed are:
(i) The design of the monograph must comply with all general requirements, test methods, texts and instructions in the IP.
(ii) A product is not of standard quality unless it meets all the requirements of the monograph.
IP 2010 contains 287 new monographs consisting of APis, excipients, dosage forms and herbal products, etc. It is hoped that this edition will play an important role in improving the quality of medicines which in turn promote public health and growth and accelerate the development of pharmaceuticals in the pharmaceutical sector.
Basis of Pharmacopoeial Requirements:
Indian pharmacopoeia latest edition has some requirements which are given below.
As in the past, this compendium offers a publicly accessible statement about the expected and always verifiable quality of a product during the accepted shelf life of the article. The established standards represent the minimum that the item must meet and it is the responsibility of the manufacturer to ensure that the item is manufactured in accordance with Good Manufacturing Practices (GMPs). It is imperative that sufficiently strict limit values are applied at the time a batch of a drug or drug is released so that the Pharmacopoeia! if stored under the specified storage conditions up to the expiry date.
It should be noted that a valid interpretation of any requirement of the Pharmacopoeia should be given in the context of the monograph as a whole, the relevant general monograph, the specified tests and analytical methods, if applicable, including a reference to the relevant general guidance. Familiarity with the general information facilitates the correct application of the requirements.
In accordance with the essential requirements of the Drugs and Cosmetics Act, 1940 and the regulations below, the information on the category of drugs, dosage, and commonly available strengths of dosage forms has been retained in this edition.
General chemical tests to identify an article have been almost eliminated and the more specific infrared and ultraviolet spectrophotometric tests have been emphasized. The concept of using published infrared spectra as a basis for identification continued,
The use of chromatographic methods has expanded significantly to meet the need for more specificity in assays, and particularly in assessing the nature and extent of contamination in drug substances and drug products. Most of the existing tests and tests for related substances will be improved by the liquid chromatography method in order to have more specificity and to harmonize with other International Pharmacopoeia.
The testing of pyrogens using animals has been practically abolished. The bacterial endotoxin test introduced in the previous edition is now applicable to more articles. The abnormal toxicity test is now limited to certain vaccines.