Demonstration of specificity

[jayroseville58]

If impurity or degradation product standards are unavailable, specificity may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second well-characterized procedure (e.g., a pharmacopeial or other validated procedure). These comparisons should include samples stored under relevant stress conditions (e.g., light, heat, humidity, acid or base hydrolysis, oxidation)

I'm confuse with the above mentioned statement. Need some clarification. Thanks.

[danko]

Which part of it confuses you?

[jayroseville58]

Which part of it confuses you?

is forced degradation studies should be always applied on our RS test method validation? thanks.

[danko]

Yes.
Unless you already know in detail the degradation products and have them available so that you can demonstrate adequate separation. The latter (the separation og the degradants from the intact molecule) and determination of those is the specificity indicator here.

Best Regards

[jayroseville58]

Yes.
Unless you already know in detail the degradation products and have them available so that you can demonstrate adequate separation. The latter (the separation og the degradants from the intact molecule) and determination of those is the specificity indicator here.

Best Regards

you mean to say, if we are able to show specificity of impurities with the use of its corresponding available standard, it is no longer required to us to conduct forced degradation?

[danko]

It is my conception anyway. Just make sure you have the right arguments for the impurities you’re focusing on. That is to say they are relevant to the drug you’re dealing with, i.e. that is what will happen upon formulation and storing the product under relevant conditions.

Best Regards