Acceptance criteria
Posted: Thu Dec 25, 2008 3:32 pm
What is the acceptance criteria (ICH/USP)for assay, content uniformity, Dissolution, Disintegration, hardness of tablets?
Regards,
Ajay
Regards,
Ajay
For USP, whatever is specified in the monograph for that compound.
I can't comment more generally about hardness, dissolution, or disintegration because those really are not chromatography questions. For assay and content uniformity, the answer is simple but vague, and based on your product specifications: good enough to tell the difference between "good" product and "bad" product. For example: if your manufacturing process has a tolerance of +/- 5%, then your analysis should be
+/- 2% (approximately!). More sophisticated statistical tests can be applied, but you have to define the desired confidence interval and confidence level.