普瑞巴林

产品名称（Product name）：普瑞巴林Pregabalin

CAS No.: 148553-50-8

批号（Batch No.):20200107

报告日期(Report Date): 20200107

有效期(Expiry Date): 20220108

执行标准（Perform standard）：USP38

检验项目

Tests

标准规定

SPECIFICATIONS

检验结果

RESULTS

外观

Appearance

类白色至白色粉末

Off-white to white powder

白色粉末

White powder

鉴别

Identification

红外吸收图谱应与对照图谱一致。

The infrared absorption spectrum of the sample should concordant with that of the spectrum of working standard of product

符合规定

Conforms

溶解度

Solubility

略溶于水

Sparingly soluble in water

符合规定

Conforms

比旋度

Specific Optical

Rotation (On anhydrous basis)（°）

+10.0°  ~  +12.0°

+10.0°

干失

Loss on drying( w/w)

≤0.5%

0.32%

硫酸灰分

Sulphate ash

≤0.1%

0.05%

Heavy Metals(%)

≤20ppm

符合规定

Conforms

对映体纯度

Enantiomeric purity

• 普瑞巴林峰面积不得超过S-普瑞巴林的0.5%
• The area of peak due to R-Pregabalin is not more than 0.5 % the area of the S-Pregabalin.

Conforms

符合规定

色谱纯度（HPLC）

Related substances

内酰胺杂质

Lactam impurities ≤0.5%

未检出

Not detected

任意单杂

Individual impurities ≤0.5%

0.42%

总杂

Total impurities ≤1.0%

0.91%

含量

Assay(%)

It content not less than 98.0% and not more than 102.0% on dried basis.

99.1%