1.0 OBJECTIVE
To lay down the procedure for the Active raw material calculation for tablets without equivalent factors
2.0 SCOPE
This SOP is applicable for Active raw material calculation for tablets without equivalent factors
3.0 BACKGROUND
NIL
4.0 RESPONSIBILITY
4.1 QA & Production-Chemist
4.2 QA-Executive
4.3 QA-Head & Production-Head
5.0 PROCEDURE
5.1 Calculate the required drug weight per Tablet with the
following formula.
Label claim in mg x 100 x __100 x equivalent factor
Drug assay ( 100-MC)
MC is moisture content
5.2 Example
Calculate quantity in Kg required for Albendazole tablets with label claim of 600 mg with batch size is 50,000 tabelets
Raw materials assay = 98.50
Moisture content (MC)= 2.10
label claim = 600 mg
600 mg x 100 x 100 x Equivalent factor (1.0)
98.50 (100-2.10)
as there is no equivalent factor i mentioned as 1.0
then
600 mg x 100 x 100 x 1.0
98.50 97.90
Then 622.20 mg per tablet
For batch
Batch size = 50,000 tablets
then 622.20 mg x 50,000 tablets
= 31110000 mg / 1000
= 31110 gm /1000
=31.11 Kg
then 31.11 Kg required per batch
6.0 ANNEXURES
Nil
0 Comments