分析项目

ITEM OF ANALYSIS

指标

STANDARD

性状

Appearance

白色至类白色结晶性粉末

white or off-white crystalline powder

鉴别

I.D.

红外鉴别

IR

样品红外图谱应于对照品图谱一致

IR spectrum should conform

保留时间

Retention time

手性纯度项下保留时间应与对照品一致

RT under chirality should conform

氯化物鉴别

Chloride

应显氯化物反应

It gives a reaction of chloride

水分Water

3.0~4.5 %

熔 点Melting Point

198~202 ℃

灼烧残渣Residue on ignition

≤ 0.2%

重金属Heavy Metals (ppm)

≤ 10 ppm

残留溶剂

Residual Solvent

二氯甲烷Dichloromethane≤0.06%

丙酮Acetone≤0.5%

乙酸乙酯Ethyl acetate≤0.5%

相关物质

Related Substances

单个杂质不大于0.5%

Single impurity ≤0.5%

总杂质不大于1.0%

Total impurity ≤1.0%

异构体

Enantiomer

不大于2%

No more than 2%

含量

Assay (HPLC)

≥ 99 %