武汉东康源科技有限公司

Product Name品名

Carbidopa

Batch No批号

20230528

Quantity数量

300kg

Specification规格

25kg/drum

Date of Sampling

取样日期

2023.05.28

Date of Reporting

报告日期

2023.05.28

Date of Expiry

有效日期

2026.05.27

Test Standard

检测标准

USP36

TESTS

SPECIFICATIONS

RESULTS

Description 外观

A white or creamy white powder

Creamy white powder

Identification 鉴别

IR 红外检查

IR spetrum is consistent with Carbidopa CRS

conforms

HPLC 液相色谱

Conform with the retention time of the major peak in the chromatogram

conforms

Specific rotation 比旋光度

-21.0~-23.5°calculated as the monohydrate

-21.8°

Loss on drying 干燥失重

6.9%~7.9%

7.3%

Residue on ignition 灼烧残渣

≤0.1%

0.05%

Heavy metals 重金属

≤0.001%

＜0.001%

Limit of Methyldopa and Carbidopa related components A 甲基多巴和卡比多巴相关物质A

Methyidopa 甲基多巴

≤0.5%

0.17%

Carbidopa related components A 卡比多巴相关物质A

≤0.5%

＜LOD(0.02%)

Any unknown impurity 其他未知名单一杂质

≤0.10%

0.07%

Total impurities 总杂质

≤1.0%

0.31%

Residual solvents 残留溶剂

Trichioromethane 三氯甲烷

≤0.006%

＜LOD(0.4ppm)

Ethanol 乙醇

≤0.10%

0.0001%

Assay 含量

98.0%~102.0%

99.7%

Particle size 粒径

NLT90% pass 100mesh

conforms

Conclusion 结论

In conformity with USP36.符合规定