QC test as per Pharmacopoeia

Quality Control
1

Dear All,
Good day.
please help in following issue.

is it mandatory that the Specification of QC test of finished product to be incorporated from same pharmacopoeia of API.

for example, Amlodipine Besylate used as BP grade, but for Amlodipine tablet, can i adopt specification and method from USP although Amlodipine tablet spec, method is present in BP.

should i have to adopt BP as API is used as BP.

please help in reference.

thank you in advance.

1 Like
2

Cross carmilose sodium as pe IP

3

No, it is not mandatory that the specifications for the Quality Control (QC) tests of a finished product must always be incorporated from the same pharmacopoeia as the Active Pharmaceutical Ingredient (API).