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.
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