检验项目TEST ITEMS

标准规定SPECIFICATIONS

检验结果RESULTS

外观 Appearance

白色或类白色粉末

A white or almost white powder

白色粉末

A white powder

鉴别 Identification

1) I R：供试品红外光谱图应与标准品一致

IR：the infrared Absorption of the test

2) RRT：在含量测试项下供试品主峰保留时间应与标准品一致

The retention time of sample corresponds to the standard

Complies

水分water  

≤0.5%

＜0.1%

硫酸盐灰份Sulphated ash

≤0.1%

＜0.1%

重金属Heavy metals

≤20ppm

＜20ppm

异构体（杂质D）Isomer（Impurity D）

≤0.50%

ND

杂质B Impurity B

≤0.10%

0.03%

有关物质 Related substances  

杂质A ImpurityA

左乙拉西坦酸Levetiracetam acid

其它单个杂质Any other individual impurity

总杂质Total impurities

≤0.05%

≤0.10%

≤0.05%

≤0.40%

ND

0.05%

ND

0.05%

含量 Assay

98.0%~102.0%

99.0%

结  论 CONCLUSION

本品按美国药典检验，结果符合规定

It complies with all the requirements of USP33