项    目Items

标    准Requirements

结    果Results

⑴

外    观Description

白色或类白色结晶性粉末

White or almost white crystalline powder

符合标准Complies

⑵

熔    点Melting Point

140~145℃

142-145℃

⑶

比 旋 度Specific Rotation

- 42～- 47°

-46.5°

⑷

酮    体Acetone body

≤0.20％

符合标准Complies

(5)

有关物质（HPLC）

Individual  Known  Impurity

单体杂质Individual impurity≤0.5%

符合标准Complies

总体杂质Sum of impurities≤1.0%

符合标准Complies

(6)

干燥失重Loss on drying

≤1.0％

≤0.5％

(7)

氯化物Chloride  Content

17.0%~17.7%

17.0%

(8)

硫酸盐Sulfate

≤0.2%

0.14%

(9)

炽灼残渣Residue on ignition

≤0.2％

≤0.1％

(10)

颗粒度Particle size

100%<100um

符合标准Complies

(11)

残留溶剂≤ppm

Residual So Vent

甲醇Methanol≤3000PPM

65ppm

异丙醇2-Prcpanol≤5000ppm

120ppm

(12)

含    量Assay (HPLC)

98％～102.％

99.8％

结    论Conclusion:       符合标准规定

Meets the requirements