Product

产品名称

PRILOCAINE base

丙胺卡因

batch No.

 批号

23043009

Mfg. date  

生产日期

2023-04-30

Approval Date

批准日期

2023-05-01

Exp. date  

有效期至

2026-04-29

Tests

项目

Results

结果

Specifications

标准

Description性状

White crystalline powder

类白色结晶性粉末

White or almost white crystalline powder白色或类白色结晶性粉末

Solubility溶解度

Complies

符合规定

Very soluble in alcohol and in acetone; slightly soluble in water.

在乙醇和丙酮中极易溶，在水中微溶。

Identification

鉴别

Complies

符合规定

By IR, to match with the working standard

红外吸收图谱应与对照品一致

Melting point

熔点

36.9℃～38.5℃

36℃～39℃

Water

水分

0.04%

≤0.5%

Residue on ignition

炽灼残渣

0.03%

≤0.1%

Related compound  A

有关物质A

Complies

符合规定

≤0.01%

Related compounds

有关物质

0.05%

not more than 0.2% of any individual impurity

任一单个杂质不得过0.2%

Complies

符合规定

not more than one impurity exceeds 0.1%

超过0.1%的杂货不得过一个

0.15%

not more than 0.5% of total impurities

总杂质和不得过0.5%

Residual solvents

溶剂残留

Not detected

未检出

Dichloromethane Not more than0.06%

二氯甲烷≤0.06%

Not detected

未检出

Ethanol Not more than0.5%

乙醇≤0.5%

0.03%

Isopropyl ether Not more than0.5%

异丙醚≤0.5%

Assay

含量

99.27%

≥99.0%

（on the anhydrous basis以干品计）

Conclusion ： Conforms to USP39

结论 ：             符合USP39标准