Bioequivalence and Bioavailability Forum

Dear colleagues,

the Guideline on bioanalytical method validation states in chapter 4.1, Reference standards "Suitable reference standards, include certified standards such as compendial standards (EPCRS, ..." We have bought such a European Pharmacopoeia Certified Reference Standard (EPCRS) from EDQM, but we were very surprised that they 1) do not provide a certificate of analysis for these standards, 2) do not indicate their expiry date and 3) they even do not specifiy the content of the compound in the standard (in some cases). They only state "If a CRS has no assigned content, this should in no case be interpreted as if the content were 100 per cent."

This seems very funny to us - a reference standard with no declared content . But, more seriously, we have to work with it. Of course, we all know that for bioequivalence studies with relative measurements the purity of the reference standard is not critical, but auditors usually have not the same opinion.

Have you any experience with these European Pharmacopoeia Reference Standards? If so, how did you solve the above problems?

Have a nice day.

Jan