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Impurity peak in WORKING STANDARD
Posted: Mon Sep 23, 2013 12:07 pm
by syedzahidhussain
I see an impurity peak in the working standard. System suit and all other criteria pass. What is the limit of imurities that I can ignore or what is the maximum area of the impurity that can be disregarded according to USP?
Thanks in advance
Re: Impurity peak in WORKING STANDARD
Posted: Mon Sep 23, 2013 12:19 pm
by HPLCaddict
What does your SOP say?
Ph. Eur. suggests a general disregard limit of 0.05% (chapter 2.2.46) if I recall correctly.
Re: Impurity peak in WORKING STANDARD
Posted: Mon Sep 23, 2013 12:49 pm
by syedzahidhussain
Thanks for the reply. SOP does not comment anything on impurity in WOrking standard. However it does limit amount of impurity in the sample.