SCOTT-EDIL PHARMACIA LTD.

UNIT-II
21-22 EPIP, Phase-I Jharmajri, Baddi, Distt. Solan (H.P.),
173205 INDIA

3.2.P Drug Products

3.2.P.1 Description and Composition of the Drug Products (FFP)

 Description:
White, round shaped, Biconvex, film coated tablet plain on both sides.
 Composition:
Each Film Coated Tablet Contains
Atorvastatin Calcium Trihydrate BP
Equivalent to Atorvastatin ...................... 20 mg

Batch Formula for Atorvastatin Tablets 20 mg

Formulation for Batch Size: 1.0 Lac tablets

S. No. Ingredients Specificat Qty. Req. Overages Actual Function
ion for 1.0 lac Qty per
tablets In Tablet
(Kg) (in mg)
DRY MIXING
1. Anti-
Atorvastatin
BP 2.1760 -- 21.760 inflammatory/A
calcium Trihydrate
nalgesic
2. Microcrystalline IH
11.524 -- 115.24 Filler
Cellulose (PH102)
3. Crosscarmellose BP
1.000 -- 10.00 Binding agent
Sodium
LUBRICATION
4. Purified Talc BP 0.500 -- 5.00 Diluent
5. Magnesium Stearate BP 0.400 -- 4.00 Lubricant
6. Sodium Starch USP --
1.000 10.00 Disintegrant
Glycolate
7. Colloidal anhydrous BP --
0.200 2.00 Glidant
silica
8 Sodium Lauryl BP --
0.200 2.00 Surfactant
sulphate
FILM COATING
9. Rapid coat universal IH
0.570 -- 4.750 Coating
(09UN60SE101)$
10. Titanium Dioxide BP 0.0100 -- 0.100 Solvent
11. Purified Water BP 3.00 -- q.s. Solvent
$ Does not appear in final Product.

Atorvastatin Tablets 20 mg
MODULE-3
 SCOTT-EDIL PHARMACIA LTD. UNIT-II
21-22 EPIP, Phase-I Jharmajri, Baddi, Distt. Solan (H.P.),
173205 INDIA

Molecular weight calculation

Molecular weight of Atorvastatin Calcium Trihydrate: 1209 g/mol
Molecular weight of Atorvastatin: 558.64 g/mol
Ratio is 2:1 so 604.50 g/mol
Factor: 1.0820

Atorvastatin Tablets 20 mg
MODULE-3