The Madras Pharmaceuticals

ATORVAS 20
(Atorvastatin Tablets 20mg)

3.2.P.1 Description and Composition of the

FPP

Version : 1.0 JUN.2017 Page 165 of 592

 The Madras Pharmaceuticals
ATORVAS 20
(Atorvastatin Tablets 20mg)

Description of the dosage form

Orange coloured circular slightly biconvexed film coated tablet with a scored in the middle on one
side.
Product Name: ATORVAS 20 (Atorvastatin Tablets 20 mg)

Composition:
Each film coated tablet contains:
Atorvastatin calcium
equivalent to Atorvastatin 20 mg

Qualitataive and Quantitative Batch formula:

Batch size: 250000 Tablets
Label
Over Specifi Added Added Reason for
S. No Ingredients claim
ages cation mg/tab kg/batch Inclusion
mg/tab
Lipid
Atorvastatin
1. 20.0 3% IH 22.252 5.563 modifying
Calcium*
agents
2. Lactose** - - BP 53.252 13.313 Diluent
Microcrystalline
3. - - BP 54.000 13.500 Diluent
Cellulose
4. Povidone K30 - - BP 1.000 0.250 Disintegrant
5. Calcium Carbonate - - BP 2.500 0.625 Binder
Croscarmellose
6. - - BP 2.000 0.500 Disintegrant
Sodium
Lubrication
7. Magnesium Stearate --- --- BP 1.000 0.250 Lubricant
Coating***
8. Opadry White --- --- IH 6.000 1.500 Coating agent
Sunset Yellow Colouring
9. --- --- IH 0.800 0.200
Lake Agent
10. Dichloromethane # --- --- BP 120.000 30.000 Solvent
11. Isopropyl Alcohol # --- --- BP 60.000 15.000 Solvent

Version : 1.0 JUN.2017 Page 166 of 592

 The Madras Pharmaceuticals
ATORVAS 20
(Atorvastatin Tablets 20mg)

Overages: 3%
*-Atorvastatin calcium quantity shall be dispensed bases on Assay.
**-Lactose shall be decided based on calculated quantity of Atorvastatin Calcium.
*** Excess coating material added is to compensate loss during the coating process.
#-will not present in the final product.

Abbreviation:
BP : British Pharmacopoeia
IH : In-House

Version : 1.0 JUN.2017 Page 167 of 592