Product Development Department

ffiritas Veritas Pharmaceuticals Ltd.

Gazipur, Bangladesh

SPECIFICATION: OF FINISHED PRODUCT

Label Clairn: Each film coated tablet contains Montelukast

ProductName : Asmatab 10 Tablet
10 mo as Montelukast Sodium INN
Document No. : SPEC/BD 001/FP/01 Version No.: : 01

Superseded Doc. : Nil Effective Date : 1210212014

Shelf Life : 36 months Review Date : flA212A17

Analytical Method
Ref.No TP/BD 001/oo Action&Use : Anti-Asthmatic

Siorage Condition " Store in a dry & cool place (below

25'C), Protected from liqht.
Presentation : Blister (Alu-Alu, 3X10's)

Sl No. TEST SPECIFICATIOI,I

A white to Off white colored, round shaped fllm coated tablet with "V"
01. Description
enqraved on one side and other side break line

02. ldentification Positive for Montelukast Sodium

03. Average weighUTablet (mg) 92.0 mg - 102.0 mg (97.0 mg t 5 %)

Out of 20 Tablets maximurn 2 tablets shall deviate + 7.S% of average
04 Uniformity of weight
weiqht and none shall deviate + 15% of averaoe weioht
05. Thickness 3.0 mm - 3.33 mm (3.17 mm t 5%)

06. LOD (%)Mater (%) Not more than 3.5%

07" Average Hardness (Kp) Not less than 4

08. Disintegration time Not more than 30 minutes

09" Dissolution Not less than 70% within 30 rninutes

10. Assay: Montelukast (mg/tablet) 9.0 mg - 11.0 mg (90.0 % - 110.0 % of the tabel claim)

11 Packaging lnformation
BatchNo.: MRP:
Mfg. Date: Exp. Date:
12. Check list Should meet

Version: 01, To set Specification of Asmatab 10 Tablet

Prepared by Checkefl by Approved by

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Designation Sr. Executive, PD Asst. Manager, QC QA Manager