產品名稱（Product name）：普瑞巴林Pregabalin CAS No.: 148553-50-8 批號（Batch No.):20200107 報告日期(Report Date): 20200107 有效期(Expiry Date): 20220108 執(zhí)行標準（Perform standard）：USP38 |
檢驗項目 Tests | 標準規(guī)定 SPECIFICATIONS | 檢驗結果 RESULTS |
外觀 Appearance | 類白色至白色粉末 Off-white to white powder | 白色粉末 White powder |
鑒別 Identification | 紅外吸收圖譜應與對照圖譜一致。 The infrared absorption spectrum of the sample should concordant with that of the spectrum of working standard of product | 符合規(guī)定 Conforms |
溶解度 Solubility | 略溶于水 Sparingly soluble in water | 符合規(guī)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 | 符合規(guī)定 Conforms |
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.
| Conforms 符合規(guī)定 |
色譜純度（HPLC） Related substances | 內酰胺雜質 Lactam impurities ≤0.5% | 未檢出 Not detected |
| 任意單雜 Individual impurities ≤0.5% | 0.42% |
| 總雜 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% |
