potency [Bioanalytics]

posted by moblak – 2010-11-03 10:00 (5717 d 08:01 ago) – Posting: # 6108
Views: 10,170

Hi Sesame,

It's 15 years since my days at university, so I hope my memory still serves me well :-D

Given the information you have provided, the calculation below would be correct (94.6% is the potency for atorvastatin AS IS)....46.9 mg of your standard for 44.4 mg of atorvastatin

❝ No way. If the potency is 94.6%, more should be weighed in in order to compensate to 100%, not less: 44.4 mg / 0.946 = 46.9 mg.


However, according to our experince with atorvastatin calcium only (not trihydrate), the atorvastatin standard is HIGHLY hygroscopic and therefore, we measure the water content by Karl-Fischer weekly (and water content has increased dramatically in some cases...a few %).
Therefore, the potency of 94.6% declared on your CoA might not be completely correct.

Cheers
Marko

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