How to calculate overage

How to calculate overage quantity of API???

Overage quantity is included in standard tablet weight or not

Dear Brijesh, To compensate the moisture present in API one shall substract the content of water present in API from its Assay on as is basis .Hence the required quantity of API is calculated using API ASSAY on anhydrous basis

Tablet weight will not have impact as the combensation of water content is always done with a suitable quantity adition of excipient ( diluent like lactose ,MCC)…

Hope it’s clear…KR Insights

1 Like