Calculation of API in pharma manufacturing ll Formula!
Calculation of Active pharmacetical ingredient: Formula: Batch size x Label claim x factor x 100 x 100 ---------------------------------------------------------------------Assay % of API X (100-LOD)X 1000 X 1000 =....... (Z) If quantity of 1st A. R no. is not sufficent then : Avialable balance of 1st A. R no............ Kg(A) Quantity required to be used from 2nd A. R No. =Z-A=...... kg(B) Calculation for 2nd A. R No. =Bx1st Assay API x 1st(100-LOD%) -------------------------------------------------=........Kg (C) Assay % of 2nd API x 2nd(100- LOD%) Total quantity of API to be dispensed= A+C=........... Kg.