产品名称（Product name）：普瑞巴林

批号（Batch No.):20191211

报告日期(Report Date): 20191211

有效期(Expiry Date): 20211211

执行标准（Perform standard）：USP38

检验项目

Tests

标准规定

SPECIFICATIONS

外观

Appearance

类白色至白色粉末

Off-white to 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

溶解度

Solubility

略溶于水

Sparingly soluble in water

比旋度

Specific Optical

Rotation (On anhydrous basis)（°）

+10.0°  ~  +12.0°

干失

Loss on drying( w/w)

≤0.5%

硫酸灰分

Sulphate ash

≤0.1%

Heavy Metals(%)

≤20ppm

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.

色谱纯度（HPLC）

Related substances

内酰胺杂质

Lactam impurities ≤0.5%

任意单杂

Individual impurities ≤0.5%

总杂

Total impurities ≤1.0%

含量

Assay(%)

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