Assay (By CPC) - on the dried basis: 90.0%～105.0%;
Appearance: Off-white free flowing powder;
|
指标 Test Items |
标准 Specification |
检测结果 Test Results |
|
含量（CPC ，以干品计） Assay（By CPC） (on the dried basis) |
90.0%～105.0% |
91.5% |
|
鉴 别 Identification |
A 、红外鉴别呈正反应；IR conforms to reference standard. |
Pass |
|
B 、（0.5g→ 10ml 溶液）显钠盐的鉴别反应。 Meets the requirements ofthe tests for sodium. |
Pass |
|
|
干燥失重 Loss on drying |
≤10.0% |
9.0% |
|
外观 Character |
白色或类白色流动性粉末，无可见异物 White to off-white free flowing powder, No visible impurities. |
White powder |
|
目数 Particle size |
100%通过 80 目 |
Pass |
|
蛋白质 Limit ofprotein (on the dried basis) |
6.0%Max（Dried Basis） |
2.9% |
|
重金属 (Pb) Heavy metals (Pb) |
20PPM Max |
Pass |
|
PH |
5.5～7.5 in a solution (1 in 100) |
6.8 |
|
澄清度 Clarity and color of solution （5% concentration） |
吸光度≤0.35(420nm) Its absorbance is not greater than 0.35（420nm） |
pass |
|
电泳纯度 Electrophoretic purity |
杂质≤2% Not more than 2% ofany individual impurity is found, |
pass |
|
比旋度 Specific rotation |
-20.0º ~-30.0º |
-24.5º |
|
氯化物 Chloride |
≤0.50% |
Pass |
|
硫酸盐 Sulfate |
≤0.24% |
Pass |
|
灼烧残渣 Residue on ignition (on the dried basis) |
20.0-30.0% |
24.2% |
|
大肠杆菌 E Coli |
Negative |
Negative |
|
沙门氏菌 Salmonella |
Negative |
Negative |
|
细菌总数 Total Plate Count |
1,000cfu/g Max |
Complied |
|
霉菌和酵母菌 Yeasts and Molds |
<100cfu/g |
Complied |
|
葡萄球菌 Staph |
Negative |
Negative |
