Mar 13

Are your assay values below specification?

“The result I’ve found for the assay value in my API or finished dosage form is below my specification. Is there a problem with my reference standard?” is a question often asked by users of pharmaceutical reference materials. Some may even assume that there has been some degradation with the reference material they have applied.

12290805 Pills Pharma Drugs MulticolouredHowever, only in rare cases can a finding like this be related to an issue with the reference standard. And certainly it cannot be linked to a normal degradation of the standard at all, because in such a case you would rather find an assay value too high for the analyte in question…..

These issues are covered in greater depth here and are also a theme of LGC’s upcoming seminar.

Don’t forget you can keep up with other blogs from LGC’s Standards teams here.

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