Finished Product Tests

R&D
1

Hey,
As a novice R&D deputy, my boss is given me the responsibility of finding an analysis method for the finished product of a drug, but I don’t know exactly where and how should I start to find information about its method of analysis. I need to know the following information:

  1. Where should I find a method of analysis for a drug? (USP, EP… In house)
  2. If a method isn’t mentioned in USP or other valid documents, how to dvelop an in-house method? what steps are involved?
  3. what are the tests for a finished product?

If anyone can answer my question I would be grateful truely.
Thanks

2

It is a very massive question, so I think it is better to ask your senior at your laboratory.

As a normal, if it is not mentioned in pharmacuetical (Actually it is very easy case) we can search an article, and apply the test condition to my project, do the method validation next…