URSODEOXYCHOLIC ACID

检验项目

Item

检验标准

Inspection Standard

检验结果

Results

外观Appearance

White or almost white crystalline powder,

白色或类白色结晶粉末

Conforms

鉴别  Identification

Enterprise Standard  企业标准

Conforms

有关物质 Related Substance

Lithocholic Acid ≤0.1%

胆石酸 ≤0.1%

Conforms

比旋度Specific Optical Rotation

+58 - +62°

+60.0°

熔点  Melting Piont

200℃ -204℃

201.3℃-202.6℃

干燥失重  Loss on drying

≤1.0%

0.6 %

灼烧残渣  Ignition residue

≤0.1%

0.08%

含量 Assay

≥ 99.0％—101.0％

100.8%

重金属 Heavy Mental

≤ 10ppm

Conforms

液相纯度

Purity HPLC

CDCA ≤1.0%

0.22%

Max. each impurity ≤0.1%

总杂

0.095%

Total Impurity ≤1.5%

0.44%

结论：本品经检验，各项指标均符合企业标准。

Conclusion: The product Conforms to the standard.