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 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
0 Comments