Hot sale & hot cake high quality Pregabalin powder 148553-50-8 with reasonable price and fast delivery !!

Product name

Pregabalin

Batch No.

20170305

MFG.Date

2017.03.05

Net Weight

30000kg

Expiry.Date

2019.03.04

CAS No

148553-50-8

Related standards

USP39

Test items

Standards

Results

Appearance

White to off-white crystalline powder

White crystalline powder

Solubility

Sparingily Soluble in water slightly

Conform

Identification color reaction

Ninhydrin reaction solution is blue purple

Conform

Identification

IR

Conform

Specific optical rotation

+8.5°~+12.0°（ODB）

+10.51°

Related substance（HPLC）

Amide≤0.15%

BQL

4E≤0.15%

BQL

5E≤0.15%

0.01%

Lactum≤0.15% 

BQL

Unknown impurity≤0.15%  

0.04%

Total impurity≤0.50% 

0.05%

Heavy metal

≤20ppm

＜20ppm

Sulphate ash

≤0.1%w/w

0.049%w/w

Loss on Drying

≤0.5%w/w

0.10%w/w

Residual solvent（GC）

Methanol≤3000ppm

45ppm

Toluene≤890ppm

BQL

N-butanol≤5000ppm

123ppm

Ethyl acetate≤5000ppm  

BQL

Chloroform≤60ppm  

BQL

N-hexane≤290ppm  

BQL

Emantiomeric purity by HPLC R-pregabalin content

Not more than 0.15% of the area of R-pregabalin

BQL

Assay（HPLC） 

98.0%~102.0%（on dried basis）

99.97%

Conclusion :The sample complies with USP39。