Elemental Impurities
USP Supporting Documents
- 232, 2nd supplement to USP 38
- 232, original General Chapter
- 232, revised notes, 1st supplement issued Feb 2015
- 233, 2nd supplement to USP 38
- 233, original general chapter
- Commentary to 2nd Supplement USP 38, relative to 232 and 233
- General Notice
- MK057 USP 232 Inside the mind of the FDA
- USP 1225 Validation Procedures
- USP FAQs from 2014 and 2015
- USP Implementation Plan for Elemental Impurities Gen Chapters 232 and 233
- USP Supplement 3, Correspondence Number C163959
- XXX notes regarding toxicity
- XXX USP General Chapter 730
EP Supporting Documents
- EMA_CHMP_SWP_4446_2000_Feb-2008-guidline-for-metal-catalysts-and-reagents
- EMA, January 2015, CHMP, ICH, 353369, 2013
- EMA, 26 Feb 2015, CHMP, QWP, 109127, 2015
- GMP news 1,2,3 &4
- IPEC Federation Publishes Position Paper on EU Risk Assessment Guidelines for Excipients
- Pharma-Tech-Europe-Artical-on-ICH-implementation-challenges-opportunities