High purity Tolvaptan API and intermediate with the single impurity is less than 0.5% CAS NO.150683-30-0

Items                     Specifications                 Results

Appearance:    light yellow or green crystalline powder       Complies

Solubility: freely soluble in absolute methanol,absolute alcohol and ethyl acetate,slightly soluble in ethyl ether,practically in soluble in water             Complies

Identification:                  HPLC                      Complies

Melting Point:                95~105℃                     100~102℃  

Total impurity:                2.0%max.                    0.6%

Single impurity:              1.0%max.                     0.14%

Loss on drying:               1.0%max.                     0.6%

Residue on ignition:           0.1%max.                    0.05%

Assay:                       98.0%min.                   99.4%

Conclusion:It 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.

Product: Tolvaptan[CAS:150683-30-0]       

Batch No: 1009002

Manufacturing Date: Sep., 2010                  

Expiry Date: Sep., 2012

Date of analysis: Sep., 2010

Quantity: 10 Kgs

Items                     Specifications                 Results

Appearance:       white or off-white crystalline powder       Complies

Identification:                 HPLC&IR                    Complies

Melting point:                 210~225℃                   214~216℃

Loss on drying:                0.5%max.                   0.2%

Residue on ignition:            0.1%max.                   0.03%

Heavy metals:                 20ppm max.                 Complies

Related substance:

Total impurity:                  1.0%max.                  0.3%

Single impurity:                 0.5%max.                  <0.1%

Assay(on the dried basis):        99.0~101.0%               99.7%

Storage:Keep in dark place,<20℃.

Conclusion:It Complies with the Enterprise’s Standard.

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.