(3R)-N-叔丁氧羰基-3-氨基-4-(2,4,5-三氟苯基)丁酸

项目

Test:

规定

Specification

结果

Result

外观

Description

白色至类白色粉末

white to Off-white  powerr

符合

Conform

鉴别/HPLC

Identification by HPLC:

样品与对照品主峰的保留时间一致

The retention time of the sample should match with working standard

符合

Conform

比旋度

specific optical rotation

+13.0° ~ +18.0°

+15.43°

纯度

Purity(PHLC):

≥99.0％

99.97%

S-异构体

S - isomer

≤0.5%

0.18%

3-氨基-4-(2,4,5-三氟苯基)丁酸3-amino-4 - (2, 4, 5-trifluorophenyl) butyric acid

≤0.5%

≤0.25%

单一杂质（HPLC）

Sigle impurity

≤0.5%

0.29%

总杂质（HPLC）

Total impurity

≤1.0%

0.03%

水份

Water(W/W):

≤0.5%

0.23%

重金属

Heavy metal

≤20ppm

符合

Conform

残渣

The residue

≤0.5%

0.14

含量测定（折干）

Determination of content/HPLC

98.0% ~ 102%

98.77%

结论

Conclusion:

符合规定

Comply with the specification