By Anonymous on Sunday, February 10, 2002 - 11:39 pm:
If the various impurities that are present in the excipient are not available, then is it adequate to show that the peak is pure by conducting peak purity studies for products that are to be submitted to USFDA?
By Anonymous on Wednesday, June 11, 2003 - 04:43 am:
If the impurities present are not availabe then one has to prove the validity of existing method with an alternative method of analysis.Conducting peak purity studies also will do but with the help of an alternative method of analysis u can prove u r method is stability indicating.
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