• Bulk API GMP Montelukast Sodium
  • Bulk API GMP Montelukast Sodium
  • Bulk API GMP Montelukast Sodium
  • Bulk API GMP Montelukast Sodium
  • Bulk API GMP Montelukast Sodium
  • Bulk API GMP Montelukast Sodium

Bulk API GMP Montelukast Sodium

Powder: Yes
Customized: Non-Customized
Certification: ISO 9001
Suitable for: Adult
State: Solid
Purity: >99%
Samples:
US$ 100/Piece 1 Piece(Min.Order)
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Diamond Member Since 2019

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Basic Info.

Model NO.
API
Transport Package
25kg/Drum
Specification
In-house
Trademark
SCM Pioneering
Origin
China
HS Code
29
Production Capacity
500kgs/Month

Product Description

   Product Description

Product name  Montelukast
Cas number  158966-92-8
Molecular formula                      C35H36ClNO3S
Molecular weight  586.18
Boiling point  750.5ºC at 760 mmHg
Relative density  1.272 g/cm3

   Certification of Analysis

 

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

Bulk API GMP Montelukast Sodium

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