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Specifications/EP:
项 目 Item | 检验标准 Acceptance criteria |
外观 Appearance
溶解性 Solubility
鉴别 Identification
比旋度(20℃) Specific optical rotation
有关物质 Related substances | 白色或类白色粉末 White or almost white powder
略溶于水，易溶于无水乙醇，几乎不溶于正庚烷 Sparingly soluble in water,freely soluble in anhydrous ethanol,practically insoluble in heptane.
符合比旋度的要求 Specilic optical rotation(see Tests) 样品红外光吸收图谱与对照品的图谱一致 IR absorption spectrum of sample should be consistent with spectrum of refcrence standard +96.0°~+100.0°
杂质A(Impurity A)≤0.3% 杂质B(Impurity B)≤0.3% 杂质D+E(Sum of impurities D and E)≤0.2% 未知单杂(Unspecified impurity)≤0.05% 总杂质(Total impurities)≤0.5% |
项 目 Item | 检验标准 Acceptance criteria |
残留溶剂 Residual solvents
水分 Water
硫酸灰分 Sulfated ash
含量 Assay
微生物限度 Microbial Limits | 甲醇(Methanol)≤3000ppm 乙醇(Ethanol)≤5000ppm 二氯甲烷(Dichloromethane)≤600ppm 乙酸乙酯(Ethyl acetate)≤5000ppm 甲苯(Toluene)≤890ppm 正己烷(Hexane)≤290ppm 吡啶(Pyridine)≤200ppm 醋酸(Acetic acid)≤5000ppm
≤0.3%
≤0.1%
98.0%～102.0%(按无水物计) (Calculated on anhydrous basis)
需氧菌总数(Total Aerobic Bacteria Count)≤200cfu/g 霉菌和酵母菌总数(Total Combined Yeasts and Molds Count)≤50cfu/g 大肠埃希菌每1g应不得检出
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Escherichia coli should be absent