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葡甲胺COA丨6284-40-8
质量报告单
CERTIFICATE OF ANALYSIS
|
品 名 Product Name |
葡甲胺（meglumine） M-methyl-D-Glucamine |
生产批号 Lot no |
20201215 |
|
生产日期 MFG. Date |
2020.12.15 |
分析日期 Report date |
2020.12.18 |
|
检验项目 Test Items |
检验指标 Specification |
检验结果 Test Results |
|
|
性状 characteristics |
类白色结晶性粉末 White crystalline powder |
合格 Qualified |
|
|
熔点 Melting point |
128-132℃ |
128.2-130℃ |
|
|
灼烧残渣 Residue on drying |
≤0.1% |
0.04% |
|
|
重金属 Heavy metals |
＜20 ppm |
＜10 ppm |
|
|
干燥失重 Lose on drying |
≤0.5% |
0.21% |
|
|
还原物 Absence of reducing substance |
符合规定 Accords with the specification |
comform |
|
|
溶液澄清度与颜色 Clarity color of the solution |
符合规定 Accords with the specification |
comform |
|
|
比旋光度 Optical rotation |
-15.7°~--17.3° |
-16.45° |
|
|
含量 Assay（on dry） |
99.0%-100.5% |
99.47% |
|
|
结论 Conclusion |
符合USP27标准规定。 The product conforms to USP27 standard. |
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