IP-2018- Addendum 2019

This Addendum has the same authority as the Indian Pharmacopoeia 2018. The General Notices, Monographs, Appendices and other contents of the Indian Pharmacopoeia that are amended by this Addendum supersede the original matter. 

This Addendum amends as well as adds new materials to the Indian Pharmacopoeia 2018. The General Notices and Appendices included in the Indian Pharmacopoeia 2018 apply to the contents of this Addendum as well unless specifically stated otherwise. Legal Notices In India, under the Drugs and Cosmetics Act 1940, the current edition of Indian Pharmacopoeia is a book of standards for drugs included therein and the standards as included in the Indian Pharmacopoeia would be official. 

Also, in several other laws of India, the Indian Pharmacopoeia is recognised as the standard book. It is expedient that enquiry be made in each case in order to ensure that the provisions of any such law are being complied with. In general, the Drugs and Cosmetics Act, 1940, the Narcotic Drugs and Psychotropic Substances Act, 1985, the Poisons Act, 1919 and the rules framed thereunder should be consulted. These statutes empower the Government agencies to enforce the law using this compendium.

 The monographs of the Indian Pharmacopoeia should be read subject to the restriction imposed by those laws which are applicable. If considered necessary, the standards included in Indian Pharmacopoeia can be amended and the Secretary-cumScientific Director is authorised to issue such amendments. Whenever such amendments are issued, the Indian Pharmacopoeia would be deemed to have been amended accordingly.

This Addendum to Indian Pharmacopoeia (IP 2018) is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a designed plan by the Scientific Body of IPC, in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about one year. Presentation The Addendum-2019 to Indian Pharmacopoeia 2018 contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction and the General Chapters.

 Monographs on dosage forms, Monographs on drug substances, Monographs on Herbs and herbal products, and Radiopharmaceutical preparations and Index. Format In an effort to make the Addendum more user-friendly, the design of the texts of the monographs and test methods are kept same. Cross-referencing has been avoided to make each monograph complete in itself, thus making it convenient to the user. 

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 expected shelf-life of the article. The standards laid down represent the minimum with which the article must comply and it is for the manufacturer to ensure that the article is manufactured in accordance with Good Manufacturing Practices (GMPs). 

It is essential that sufficiently stringent limits are applied at the time of release of a batch of a drug substance or a drug product so that the pharmacopoeial standards are met until its expiry when stored under the storage conditions specified. It must be noted that a valid interpretation of any requirement of the Addendum should be done in the context of the monograph as a whole, the relevant general monographs, 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 General chemical tests for identification of an article have been almost eliminated and the more specific infrared, ultraviolet spectrophotometric, HPLC and HPTLC 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 the 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 have been upgraded to liquid chromatography method in view to have the specificity and to harmonise with other International Pharmacopoeias to the extent necessary.

General Chapters Keeping in view the essential requirement for harmonization of analytical methods with those adopted internationally, steps have been taken for monitoring the quality of drug. Monographs The general monograph for the API and the dosage form have been grouped together intially. They are followed by herbs and herbal products and finally radiopharmaceutical preparations. Special emphasis has been given to the dosages form for API whose dosage forms were not in IP-2018.