The qualification of a working or in-house reference standard
generally involves at the least both chemical and physical testing.
The qualification process is generally documented in a lab SOP and
entails a stability indicating and specific Assay (usually
chromatographic), one or more tests for significant impurities, two
tests for Identity of the species, a water or moisture determination
(if appropriate), residual solvents and if appropriate, a test for
polymorphism. The monograph used by your laboratory (e.g., USP, EP,
developed in-house) contains test methods which can be used for this
purpose. The Official RS is used to test the new RS candidate. Since
your client insists on NMR for identification and LC-MS for Assay,
you may want to success that the simpler IR, UV, HPLC Retention Time
match would be simpler, less labor intensive as would the validated
specific Assay method for the API.
Bob K.
Robert Kirsch, Ph.D.
The GMP Discussion Group is sponsored by gmp review - see
http://www.pharmweb.net/gmp.html
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