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VERITAS PHARMACEUTICALS LIMITED,

ffieritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

s PECTFICATION (RAW,, MATERIAL)

MaterialName Montelukast Sodium INN Code No. : 1113010


Document No. sPEC/A/1 1 13010/01 Version :
No.: 01

Superseded Doc. AM-0512 lssue Date : 21l'{ial 2014


Reference INN Review Date : 19 l,llar'2017

Reason for Revision To change the Specification No.

Storage Condition ln an airtiqht container, protected from liqht.

Test Procedure Ref. TP/1113010/0'l

Tests Specifications

01 Appearance White to pale yellow powder.

02 Solubility Freely soluble in water and in methanol, soluble in ethanol (96%) and practically
insoluble in acetronitrile.

03 ldentification A. IR: Must match with that of standard.


B. HPLC: The retention time of the principal peak obtain in sample solution is
concordant with that of working standard.
c, Test for Sodium.
04 Water by Karlfisher Not more than 3.0%

05 Heavy metals Less than 20 ppm

06 Specific optical Rotation +95.0'to + 106.0"

07 Related substances

Montilukast sulphoxide 0.30 % maximum

Montelukast Styrene 0.30 % maximum

Single maximum impurity 0.30% maximum

Total impurities 1.0 % maximum

0B Assay ( On Anhydrous Basis) 98.0% to 102.00/o

Form No.: VPL-QC-O13-02/01

Prepared by Checked by Approved by

\z%n\V
Sign & Date

Name
lff ae I l/r
Md. Monjur Rahman
l-',"f;,li;r,a
Md. Tarikul Islam Bossunia
Wilt,lt\
Md. Moniruzzaman
Designation Executive, Quality control Asst. Manager, QC Quality Assurance, Manager

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