產(chǎn)品名稱（Product name）：普瑞巴林

批號（Batch No.):20191211

報(bào)告日期(Report Date): 20191211

有效期(Expiry Date): 20211211

執(zhí)行標(biāo)準(zhǔn)（Perform standard）：USP38

檢驗(yàn)項(xiàng)目

Tests

標(biāo)準(zhǔn)規(guī)定

SPECIFICATIONS

外觀

Appearance

類白色至白色粉末

Off-white to white powder

鑒別

Identification

紅外吸收圖譜應(yīng)與對照圖譜一致。

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

對映體純度

Enantiomeric purity

• 普瑞巴林峰面積不得超過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.

色譜純度（HPLC）

Related substances

內(nèi)酰胺雜質(zhì)

Lactam impurities ≤0.5%

任意單雜

Individual impurities ≤0.5%

總雜

Total impurities ≤1.0%

含量

Assay(%)

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