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Levodopa

Levodopa

PRODUCT NAME

产品名称:

LEVODOPA USP

卡比多巴 USP

CAS NO.:

CAS编码

59-92-7

BATCH NO.

批号

20160505

MANUFACTURING DATE

生产日期:

MAY,2016

PACKING

包装:

25Kgs/Drum,25公斤/桶

EXPIRY /RETEST DATE

有效期至:

APR.,2019                             

QUANTITY( NET WEIGHT )

净重:

500Kgs

500公斤

COUNTRY OF ORIGIN

原产国

CHINA

中国

 

ITEMS

检验项目

SPECIFICATIONS

标准规定

RESULTS

结果

Description

外观

A White Or Slight Cream Crystalline Powder Odorless

白色或微白色结晶粉末,无臭

White Crystalline Powder

Identification

鉴别

Infrared Absorption

红外光吸收光谱和对照光谱一致

Infrared Absorption

对照光谱一致

Solubility

溶解度

Complies

符合规定

Complies

符合规定

Acidity of Alkalinity

酸碱度

4.5-7.0

5.55

Color of Solution

溶液颜色

Complies

符合规定

Complies

符合规定

Light Absorption

光吸收度

137-147

140.2

Specific Rotation

比旋光度

-160°~ -167°

 

-165°

Heavy Metals

重金属

≤20ppm

<10ppm

Related Compound A

相关物质A

≤0.1%

Not Detected

Impurity B

杂质B

≤0.1%

0.08%

3-Methoxytyrosine

3-甲氧基酪氨酸

≤0.50%

Not Detected

1-Veratrylglycine

3,4-二甲氧基-L-苯丙酸铵

≤0.1%

Not Detected

Unspecified impurities

单个未知杂质

≤0.1%

0.05%

Total Impurities

总杂质

≤1.1%

0.50%

         Loss on Drying

干燥失重

≤0.5%

0.15%

Residue on Ignition

灼烧残渣

≤0.1%

0.03%

Assay ( Dry basis C9H11NO4

按干燥品计算含

99.0%-101.0%

99.68%

CONCLUSION: THE BATCH CONFIRM WITH USP35 SPECIFICATIONS.