Fri, 22 Aug 2014

Comparative Study of In-Process and Finished Product Quality Control Testís Of IP, BP, USP, EP, JP for Parenterals

 

N. Srujana, Venkata Nitin Chilukuri, Valluru Ravi, Balamuralidhara.V*, Pramodkumar. T.M

 

1. Dept of Pharmaceutics, J. S. S. College of Pharmacy, J. S. S .University, Mysore Karnataka-570015


 

ABSTRACT

The present study deals with the elaborated overview of comparative study of in-process and finished product quality control tests for parenteral products taking compendia specifications of Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) into consideration. When it comes to most sensitive parts of body i.e.; veins, a high degree of precautions should be taken during and after production of product for it to avoid any hitches. The sterility of these parenteral products, as well as accuracy in the calculation and preparation of doses is of great importance and a must in terms of compliance. The high graded quality product always refers to a product which is within the compendia limits. This article focuses on the comparison of Pharmacopoeial specifications of parenteral preparations, the procedures that are employed to maintain the quality and sterility of these ophthalmic products. This covers specifications and limits of different dosage forms according to different Pharmacopeia (like IP, BP, USP, JP etc.) which helps in comparative study of specifications provided in different Pharmacopeia as well as highlighting the differences in standards and also focussing on the specifications of different nations. Different regulatory requirements of the respective countries demand products with different specific limits so this comparative study will help in meeting all the requirements of all the pharmacopoeias and later the regulatory requirements of that particular country.

Keywords: Indian Pharmacopoeia (I.P), British Pharmacopoeia (B.P), United States Pharmacopoeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and parenteral.


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