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Related substances calculation as per EP

Posted: Sat Jul 23, 2011 8:36 am
by vishall79
Dear All,
I am preparing a standard testing procedure of a EP monograph.
As per EP calculations, impurities peak areas are compared with dilute test solution. here the weight of test material taken is not taken into comparision. Can anybody please explain me complete calculation of Related substances in EP?
Should the weight of the test material be taken in calculation?

Re: Related substances calculation as per EP

Posted: Mon Jul 25, 2011 3:20 pm
by krickos
Hi

Traditionnaly the EP related substances tests are designed more as limits test rather than quantative where the diluted "standards" are compared with the sample preparation. Thats the reson why actual weight is not taken into account.