When we qualified our API or substance agaisnt reference standard then we can give potency of standard above 100.0% for routine analysis? If not then Why?
Practically it is not possible to get potency greater than 100 for any standard when you are qualified it against official standard. If you are getting such results like 101%, we can consider it analytical deviation and we can use potency as 100%. But if you are getting potency like 102%, then it is very necessary to confirm the things with high degree of investigation.
Hi Rahul,
Yes Rahul the potency of your API can be given above 100% compared to the standard. We can take the potency of the standard = 100% and then compare your API's potency against the standard. However, there are other analysis like potency index etc. which would include the control also during calculation. ATB
Thanks vivek , but i saw many industries in pharma that they round the potency to 100% for routine application e.g. If found against USP RS it 101.8 % it rounded to 100 % for routine analysis and they got no Query from FDA
Practically it is not possible to get potency greater than 100 for any standard when you are qualified it against official standard. If you are getting such results like 101%, we can consider it analytical deviation and we can use potency as 100%. But if you are getting potency like 102%, then it is very necessary to confirm the things with high degree of investigation.
Hi Rahul,
I am agree with response of Mr. Vinod.
Moreover, I would like to share some of the possibilities of getting potency grater than 100% with you; which could help you in the shared concern....
1) Number of standard preparations are not sufficient.
For example; take reference standards separately prepared in triplicate, inject three injections of each and check the % variation in between them. It seems that standard preparation makes grate impact on the assay value.
2) Water content, residual solvent content impact on the assay value. Please check the LOD (loss on drying).
Also do the values check for water content, LOD (loss on drying) and residual solvent content, as it will impact on the calculations and thus assay values.
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