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CERTIFICATE OF ANALYSIS
产品名称Product Name:L-脯氨酸L-PROLINE |
|
批号Batch No.:231004 |
数量Quantity:1000KGS |
生产日期Manufacture Date:10.04, 2023 |
有效期至Expiry Date:10.04, 2026 |
项目Items |
标准Specifications |
结果Results |
外观Appearance |
白色结晶或结晶性粉末 White crystals or crystalline powder |
Conforms |
鉴别Identification |
红外图谱 Infrared Absorption |
Conforms |
比旋度Specific rotation [α]D25 |
-84.3°~ -86.3° |
-85.0° |
氯化物Chloride(Cl) |
≤0.05% |
<0.05% |
硫酸盐Sulfate(SO4) |
≤0.03% |
<0.03% |
铁盐Iron(Fe) |
≤0.003% |
<0.003% |
重金属Heavy metals(Pb) |
≤0.0015% |
<0.0015% |
干燥失重Loss on drying |
≤0.40% |
0.05% |
灼烧残渣Residue on ignition |
≤0.40% |
0.06% |
色谱纯度 Chromatographic purity |
单个杂质不超过0.5%,总杂质不超过2.0% Not more than 0.5% of any individual impurity is found; Not more than 2.0% of total impurities is found |
Conforms |
有机挥发物 Organic volatile impurities |
应符合规定 Meets the requirements |
Conforms |
含量Assay |
98.5~101.5% |
99.6% |
结 论:本批产品经检验符合美国药典USP32标准。 Conclusion:This Batch Is Conforming With The Standard Of USP32. |