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Contact us
PHARMA Links
[India]
Address:
304, Deora Commercial Centre, Orlem Marve One Way Road, Malad (West) Mumbai 400 064 Mumbai Maharastra 400 064 India
Phone:
91-22-28620657
Contact name:
Pranay Nikam , Director
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Anti-Asthmatic

Montelukast Sodium

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Certificate of Analysis

Sr.No.

Test

Specification

Result

1

Description

Off white to light yellow powder

A light yellow powder.

2

Solubility

soluble in methanol

Complies

3

Identification

3.1 a)By IR

 

 

      b)

 

 

 

IR Spectrum of the sample should match with that of standard spectrum.

 

The Retention time of major peak of sample should correspond to that of standard by HPLC

 

Complies

 

 

Complies

 

 

3.2 Test for Sodium

Shall respond to test for sodium

Complies

 

4

Water Content by KF (%w/w)

Not more than 2.0

1.1

5

Heavy Metals (ppm)

Not more than 2.0

Less than 20

6

Related substances by HPLC(%)

6.1 Any individual impurity

6.2 Total Impurities

 

Not more than 0.5

Not more than 1.5

 

0.19

0.58

7

Assay by HPLC (%w/w)

(on anhydrous basis)

 

98.8 to 102.0

100.0

 

8

Residual solvents/OVi by GC-HS (ppm)

a.       Methanol

b.       Acetone

c.        Acetonitrile

d.       Dichloromethane

e.        N- heptane

f.        Ethanol

g.        Toluene

h.       tetrahydrofuran

 

 

 

Not more  than 3000

Not more  than 5000

Not more  than 410

Not more  than 600

Not more  than 5000

Not more  than 5000

Not more  than 890

Not more  than 720

 

 

7

Not detected

Not detected

Not detected

1488

Not detected

588

142

9

Acetic acid content by GC

(ppm)

Not more than 5000

1416




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