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stability indicating methods

Posted: Sun Nov 19, 2006 10:17 pm
by srdales
For drug products, are individuals validation preservatives and antioxidant methods to be stability indicating?

Posted: Mon Nov 20, 2006 5:19 am
by JM
Yes !!

JM

Posted: Tue Nov 21, 2006 3:02 am
by syx
I think the indicating stability test should be done to the finished formula, especially when the additional substances in the formula are soluble in the solvent. The data from this test is needed to ensure specificity of determination method for aged products.