Manufacture Montelukast Sodium Stock CAS NO.151767-02-1

Items                     Specifications                 Results

Appearance:         white or almost white powder           Complies 

Specific rotation:             +99⁰~+103⁰                            +102⁰

Identification:  

Physical chemistry Identification:positive reaction              Complies

HPLC:                  The retention time of test           Complies

sample major peak complies to reference standard

Infrared Absorption:   complies with reference standard        Complies

Sodium Identification:     the solution so obtained             Complies

responds to the tests for sodium

PH:                             9.0-10.5                   9.5

Related Impurity:     

Single impurity:                   0.5%max.                 0.3%

Total impurity:                    1.0%max.                 0.5%

S-Isomer:                        1.0%max.                 0.55

Residual solvents:

Hexane:                        0.029%max.                Complies

THF:                        0.072%max.                 Complies

Methanol:                    0.3%max.                   Complies

Toluene:                    0.089%max.                  Complies

Pyridine:                     0.02%max.                  Complies

DMF:                       0.088%max.                  Complies

Loss on drying:               1.0%max.                    0.6%

Heavy metals:               20ppm max.                   Complies

Microbe:

Bacteriam:                 1000cfu/g max.                 40cfu/g

Mildew:                     100cfu/g max.                 0cfu/g

Coliform:                       0cfu/g                     0cfu/g

Assay(dried basis):            99.0%min.                   100.0%

Conclusion: Complies with the Enterprise’s Standard .

HANGZHOU THINK CHEMICAL CO., LTD. (THINKCHEM) is an integrative corporation of trade, research and contract manufacture.

With about ten years of business experiences on the marketing & distribution, thinkchem specializes in exporting pharmaceuticals, veterinary drugs, feed additives, intermediates, fine chemicals, plants extracts, pesticides, food & nutrition additives.

Thinkchem is good at offering excellent outsourcing services to overseas customers as well as laboratory support.

Custom manufacture

Thinkchem is good at offering contract manufacture and custom synthesis under confidential agreement timely and effectively, and providing sales service from grams ,kilograms to multi-tons particularly for pharmaceuticals and their intermediates discovery and development. Thinkchem is equipped with modern lab apparatus including HPLC, GC. TLC AND NMR, motivated by a team of highly qualified personnel using these equipments.

Staff

Thinkchem is composed of chemical technicians, analytical chemists, organic chemists, and chemical engineers educated in leading universities in china. Our staff is supported by a group of consultants from academia with expertise in chemical synthesis and analytical chemistry.

1. Well-trained professional sales team dedicated to source, audit and export.

2. Well-trained R & D team equipped with new knowledge, new ideas and new insights to support product development and innovation.

3. Well-established partnership with major pharmaceutical and chemical companies in china.

4. Wide range of products and efficient regulatory documentation offered to customers.