产品名称Product Name: | 硫辛酸Alpha Lipoic Acid (USP31) | ||
产品数量Quantity: | 100kg | 生产日期Mfg. Date: | 2015-11-09 |
产品批号Lot No.: | RLE141109 | 有效日期Exp. Date: | 2017-11-09 |
项目ITEMS | 指标SPECIFICATIONS | 结果 TEST RESULTS | |
外观Appearance | 淡黄色结晶粉末 Yellowish Crystalline Powder | 符合Complies | |
鉴别Identification(HPLC) | 与标准品硫辛酸出峰时间一致Meets the requirements | 符合Complies | |
熔点Melting Point | 60~62℃ | 60.8℃ | |
溶解度Solubility(1N NaOH) | 澄清,浅黄色 Clear and Pale Yellow | 符合Complies | |
炽灼残渣 Residune on Ingnition | ≤0.10% | 0.03% | |
重金属Heavy Metals | ≤10ppm | <10ppm | |
氯化物Chloride | ≤0.10% | <0.05% | |
干燥失重Loss On Drying (Vacuum 40℃ 3hr) | ≤0.20% | 0. 04% | |
含量Assay(by HPLC,USP Method) | 99.0~101.0% | 99.52% | |
旋光度Specific Optical Rotation | -1℃~+1℃ | 符合Complies | |
相关物 Related Substance (by HPLC) | |||
单一杂质 Single Impurity 6,8-表三硫辛酸 6,8-Epitrithiooctanoic Acid 杂质总量 Total Impurities | ≤0.10% ≤0.10%
≤0.50% | 0.03% 0.02%
0.06% | |
聚合物 Polymers (by TLC) | ≤2.0% | <2.0% | |
残留溶剂 Residual Solvents (by GC) | |||
甲苯 Toluene 环已烷 Cyclohexane | ≤30ppm ≤0.20% | <25ppm 0.06% | |
微生物 Microbiology | |||
需氧菌总数 Total Aerobic Counts 霉菌和酵母菌 Mould & Yeast 大肠杆菌 E.coli 沙门氏菌 Salmonellas | ≤1000CFU/g ≤100CFU/g 不得检测到 Not Detectable 不得检测到 Not Detectable | <100CFU/g <10CFU/g 未检测到 Undetected 未检测到 Undetected |