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About Michael 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

Past/Present clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

You are here: Experts > Health/Fitness > Pharmacology > Pharmaceuticals > DMF grade APIs

Topic: Pharmaceuticals

Expert: Michael Anisfeld
Date: 9/5/2007
Subject: DMF grade APIs

Question
Is DMF grade API different from any standard pharmacopoeia like US/NF or BP ?
If yes can it be analyzed as per these standards?
If no, what way it differs and procedure of analysis should be as per which standard?

Answer
There is no such thing as "DMF grade". APIs are manufactured to pharmacopoeia standards.

DMF (Drug Master File) merely means that you have advised the health authority of the manufacturing and testing methodologies you have used - it is not an indication of pharmacopoeal specification or that you manufacture acccording to GMP.

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