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Book Detail

Title Indian Pharmacopoeia 2014 Addendum 2015 
Author IPC  Publisher
IPC
Category Indian Pharmacopoeia  Year
2015
Price Listed INR 5000  ISBN
938123809X
Picture  
Notes Features of IP Addendum 2015 to IP 2014





Introduction





IP Addendum 2015 to Indian Pharmacopoeia (IP 2014) is to be published in accordance with a


designed plan by the Scientific Body of IPC, in fulfillment of the requirements of the Drugs and


Cosmetics Act and the Rules there under.





The Addendum 2015 to Indian Pharmacopoeia 2014 contains the Notices, Preface, Structure of


the IPC, Acknowledgements, Introduction and the General Chapters. Monographs on dosage


forms, Monographs on drug substances, Monographs on Vaccines and Immunosera for human


use, Herbs and herbal products, and Radiopharmaceutical preparations and Index.





This Addendum has the same authority as the Indian Pharmacopoeia 2014.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 2014.





The General Notices and Appendices included in the Indian Pharmacopoeia 2014 apply to the


contents of this Addendum as well unless specifically stated otherwise.





Changes:





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 ingredients and products.





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





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.





According we have revised general chapters on volumetric glasses, peptide mapping, sterility


testing, conductivity, solubility, dissolution test, bulk density and tapped density of powders.





For controlling the microbial quality of all the medicinal product general chapters on microbial contamination in nonsterile products and test for colony forming units have been revised.





Specific Features of Addendum 2015





(i) 57 new Chemical monographs


(ii) 13 new Herbal monographs


(iii) 02 new Human Vaccines Monographs


(iv) 10 Radiopharmaceutical Monographs


(v) 06 Revised monographs


(vi) 29 Revised tests


(vii) About 20 new IR spectras


 
 

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