AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
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Expert: Michael Anisfeld Date: 9/11/2007 Subject: Analytical method development
Question Dear Sir,
How to ensure that all the known and unknown impurities of the sample are dissolved in specified diluent and how to select diluent in case of if all the known impurities are not available in sufficient quintity.
Thanks,
Bipin
Answer Great Question. The answer is entirely found under the "forced degradation" section of the ICH Stabilty Guidelines (ICH-Q1) and in the analytical valiudation guidelines (ICH-Q2), which can be found at the ICH website (www.ich.org).
When the webpage comes up, click on the large blue colored letter "Q" at the top left of the page, then scroll down the new page to these guidelines.
