As per standard BOM quantity of API on the basis 100% assay suppose we receive API with 102 % assay then we considered it 100% or calculate API Quantity as per 102% API assay
Consider as a 100%.
If we calculate assay ‘‘as is’’ does it effects process validation?
In general, there will be no effect on process validation w.r.to quality, because for formulation product assay range will be 90.0 to 110.0% in some cases it will be 95.0 to105.0%.
Hence there will be no impact on the assay of the finished product, when usage of API having assay 98.0 to 102.0%.
Thank you!
This topic was automatically closed 3 days after the last reply. New replies are no longer allowed.