Chromatography Forum

Hi, I have to do a gmp validation of a finished product.

There are only synthetic impurities in the drug substance used in the manufacture of the finished product.

Therefore we are only using these impurites in the resolution/peak id solution.

Do these impurities require full characterization, ie chromatographic purity and spectroscopic analysis before use?

Thanks Martina

Hi

The ICH Q2 guideline calls for "well characteriazed reference materials with a documented purity, the degree of purity depends of the intended use". a bit fluffy but if you for example check ICH Q7a § 11.17-19 and the definitions of primary/secondary reference standards in the end of Q7a, that would likely give you some idea.

Unless you can assign the impurities as "secondary reference standard" I doubt that you can completly rule out verification of Identity by NMR/MS etc. Contract labs for reference standards usually attach MS/NMR data to the CoA.