USP Standard for Dissolution Testing withdrawn
![Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training](files/eca/userImages/training.img/Z-ECA-Stability-Studies-Shipping-Distribution-LOT.jpg)
Recommendation
12/13 September 2024
In a notice from 20 December 2011 the United States Pharmacopeia (USP) has notified that Chlorpheniramine Maleate Extended-Release Tablets RS will be withdrawn as of 1 February 2012.
These tablets had been used for testing the Performance Verification Suitability according to the General Chapter <711> for Apparatus 3.
This withdrawal is due to the fact that no suitable replacement candidate has been found to date.
USP remains convinced that a Performance Verification Test is a critical element in the qualification of dissolution apparatuses.
During the ECA Conference "Dissolution Testing - Development - Quality Control - and in vivo Relevance" taking place from 17-19 October 2012 in Berlin, the newest USP requirements concerning the qualification of apparatuses will be presented and compared to the FDA requirements on mechanical qualification.
Please also read USP's complete notice.
Author:
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
24.07.2024FDA Warning Letter to Chinese OTC Manufacturer for Lack of Analytical Test Data
10.07.2024Pharmeuropa: Two Revised Chapters on Dissolution Testing published for comments
03.07.2024FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use
12.06.2024NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles
22.05.2024Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1
22.05.2024FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations