普瑞巴林
產(chǎn)品名稱(Product name):普瑞巴林 批號(Batch No.):20191211 報告日期(Report Date): 20191211 有效期(Expiry Date): 20211211 執(zhí)行標(biāo)準(zhǔn)(Perform standard):USP38 | |
檢驗項目 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 |
|
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. |