Chromatography Forum

Posted: **Sat Sep 28, 2013 8:55 pm**

The company I work for has started to produce USP grade IPOH. Will the lab need to follow the monograph for UPS IPOH to the letter, or will the customer analyze their IPOH, raw material, using USP methods.

Thanks

Posted: **Sun Sep 29, 2013 10:45 pm**

I believe that if you label it as USP you must be able to document that (i.e. test it to the monograph standard or equivalent).

Posted: **Mon Sep 30, 2013 6:33 pm**

I believe that if you label it as USP you must be able to document that (i.e. test it to the monograph standard or equivalent).

Your lab would need to use USP or compendal procedures to run your tests, or validate different methods.

If you modify any of those methods, you better document well, and have studies and good documentation to back that up.

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