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Reference Std.

Contribution from Ana Madrid written on 6/25/2008 at 14:38

We are a company that produces APIs. It could be easy for us to produce the drugs and impurities by ourselves and become then in reference std. for the APIs test control.
We want to know if we could use those std. prepared in house, characterized, instead of the compendial ones availables in USP or EP.
We could use them, or we need to standarise them against the compendial std.?
Thanks a lot!!!!

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