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Montelukast Manufacturing Thailand, the United Kingdom and USA
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Montelukast

  • Product Name : Montelukast
  • Grade : IP / BP / USP
  • Therapeutic Category : Anti Inflammatory
  • CAS No : 158966-92-8
  • Other Name : Montelukast sodium
  • COA : Available
  • MSDS : Available

Description

Montelukast is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, primary dysmenorrhoea (i.e. dysmenorrhoea not associated with known causes; see dysmenorrhea causes), and urticaria.It is mainly used as a complementary therapy in adults in addition to inhaled corticosteroids, if they alone do not bring the desired effect. It is also used to prevent allergic reactions and asthma flare-ups during the administration of intravenous immunoglobulin.

Specification:                

Item

Specification

Description

White or off-white powder

Assay

≥99.0%

Identification

 

Chemistry

Must conforms to standard

Identification

(HPLC)

The retention time of test sample major peak complies to reference standard

Infrared absorption

Must complies to reference standard

Sodium identification

The solution so obtained responds to the tests for sodium

pH

9.0~10.5

Impurity

Not more than 0.5% of any individual impurity is found,

the sum of all impurities found is not more than 1.0%

S-isomer

NMT 1.0%

OVI

Must conforms to standard

Heavy metals

NMT 20ppm

Loss on drying

NMT 1.0%

microbe

 

Bacterium

NMT 1000 cfu/g

Mildew

NMT 100 cfu/g

Coliform

NMT 0 cfu/g

 

Packaging details:

 

 

Packaging details:

5 kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.

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