Active raw material calculation for tablets without equivalent factors

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.

Drug weight per tablet (mg) = 

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