項    目Items

標    準Requirements

結    果Results

⑴

外    觀Description

白色或類白色結晶性粉末

White or almost white crystalline powder

符合標準Complies

⑵

熔    點Melting Point

140~145℃

142-145℃

⑶

比 旋 度Specific Rotation

- 42～- 47°

-46.5°

⑷

酮    體Acetone body

≤0.20％

符合標準Complies

(5)

有關物質（HPLC）

Individual  Known  Impurity

單體雜質Individual impurity≤0.5%

符合標準Complies

總體雜質Sum of impurities≤1.0%

符合標準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)

硫酸鹽Sulfate

≤0.2%

0.14%

(9)

熾灼殘渣Residue on ignition

≤0.2％

≤0.1％

(10)

顆粒度Particle size

100%<100um

符合標準Complies

(11)

殘留溶劑≤ppm

Residual So Vent

甲醇Methanol≤3000PPM

65ppm

異丙醇2-Prcpanol≤5000ppm

120ppm

(12)

含    量Assay (HPLC)

98％～102.％

99.8％

結    論Conclusion:       符合標準規定

Meets the requirements