Can we use assay as a identification test for usp offical product whoes seprate identification test is not mentioned in USP monograph. is there any such guidance document.
You can identify the product by IR or UV instead of Assay.
Hi if your are following a USP monograph, you need to follow the identification parameters as specified in monographs. Yes, it can be used for identification of your product but better to use some another identification technique as well.
I recommend to strictly follow the USP monograph.
I think Finished product doesn’t need Identification test because all test has to be done in Raw material aspect but some basic test( Assay and PH) should be done in process and Finished stage. Keep in mind all test had to be done in First three batch as validation in Finished product . From these batches onward basic test is enough.
If Assay Method By HPLC,
If same sample is coming for Assay and identification then you can consider Assay as identification, But Identification sample coming after packing Then you inject only One Blank, one Standard and one injection of sample(Only RT Purpose) -
If assay method By titration or UV. Then you have to perform ID By IR or Chemical