Tablets API calculation with equivalent factors

1.0 OBJECTIVE 

To lay down the procedure for the Active Raw Materials calculation for tablets with equivalent factors 

2.0 SCOPE

This SOP is applicable for Active Raw Materials calculation for tablets with equivalent factors 

3.0 BACKGROUND 

NIL

4.0 RESPONSIBILITY

4.1 IPQA-Chemist 

4.2 IPQA-Executive

4.3 QA-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 or water content 

5.2 Example 

Calculate quantity in Kg required for Ciprofloxacin tablets with label claim of 500 mg with batch size is 50,000 tablets

Label Claim:

CIPROFLOXACIN HYDROCHLORIDE TABLETS IP

Each film coated tablet contains:

Ciprofloxacin Hydrochloride   IP

Equivalent to Ciprofloxacin                500 mg

Colour: Titanium Dioxide        IP

Raw materials assay = 98.50
Water content (MC)= 5.10 ( Limits: 4.7 to 6.7%)
label claim = 500 mg 

Equivalent factor Calculation:

MW of Ciprofloxacin Hydrochloride: 385.80

MW of Ciprofloxacin: 331.40

Equivalent Factor = 385.80/331.40 = 1.16

Formula = Label Claim (mg) x [100/assay]x[100/(100-Water)]x Equivalent factor

500 mg     x       100     x               100            x 1.16
                         98.50                (100-5.10)

500 mg     x       100   x               100            x 1.16
                         98.50                  94.90

Then  620.48 mg per tablet

For batch

Batch size = 50,000 tablets

then  620.48 mg x 50,000 tablets

= 31024000 mg / 1000
= 31024 gm /1000
= 31.024Kg

then 31.024Kg required per batch 

6.0 ANNEXURES 

Nil