Bioequivalence and Bioavailability Forum • Polymorphic form of reference standard

Debbie
★

India,
2009-06-02 19:56
(6229 d 13:03 ago)

Posting: # 3807
Views: 2,934

Polymorphic form of reference standard [Bioanalytics]

Hello,

during the analysis of a BE study, the working standard used was one of the polymorphic form of the drug molecule.
is it acceptable to use a polymorphic form for the preparation of CC and QC samples and used for the quantification of BE study samples.

the assay method was LC/MS/MS, and there is no change in the molecualr weight, as it is the just the polymorphic form.

could the change in the polymorphic form has any impact on the quantification in the BE study?

Regards,

Jaime_R ★★ Barcelona, 2009-06-02 20:10 (6229 d 12:49 ago) @ Debbie Posting: # 3808 Views: 2,205	Polymorphic form of reference standard Post reply
	Dear Debbie, ask yourself a simple question: what physicochemical properties do you expect to be different once the compound is in solution? — Regards, Jaime