Bupivacaine HCL

Product

产品名称

BUPIVACAINE Hydrochloride MONOHYDRATE

盐酸布比卡因

batch No.

批号

18052208

Mfg. date

生产日期

2018-05-22

Approval Date

批准日期

2018-05-23

Retest. date

复验期至

2020-05-21

TESTS

项目

RESULTS

结果

SPECIFICATIONS

标准

Description

外观

White crystalline powder.

白色结晶性粉末

White, odorless, crystalline powder.

白色，无臭，结晶性粉末

Solubility

溶解度

Complies

符合规定

Freely soluble in water and in alcohol; slightly soluble in chloroform and in acetone.

易溶于水和乙醇，微溶于氯仿和丙酮

IdentifIcation

鉴别

Complies

符合规定

A: By IR, To match with working standard

红外吸收图谱应与对照品一致

Complies

符合规定

B: By UV, To match with working standard

紫外吸收图谱应与对照品一致

Complies

符合规定

C: Chloride test

氯化物应符合规定

PH

酸度

5.33

4.5 ~ 6.0

Water

水分

5.30%

4.0% ~ 6.0%

Residue on ignition

炽灼残渣

0.03%

≤ 0.1%

Heavy metals

重金属

＜ 0.001%

≤ 0.001%

Limit of residual solvents

溶剂残留

Not detected

未检出

N-methyl pyrrolidone Not more than 0.053%

N-甲基吡咯烷酮≤0.053%

0.009%

Acetone Not more than0.5%

丙酮≤0.5%

0.012%

Methyl isobutyl ketone Not more than 0.5%

甲基异丁基甲酮≤0.5%

Not detected

未检出

Glacial acetic acid Not more than 0.5%

冰醋酸≤0.5%

Not detected

未检出

Ethanol Not more than 0.5%

乙醇£ 0.5%

Not detected

未检出

Sum of alcohol and isopropyl alcohol Not more than 2%

乙醇和异丙醇≤2%

Chromatographic purity

色谱纯度

Complies

符合规定

the R_F value of the principal spot from the Test solution corresponds to that of the Standard solution, and the estimated size and intensity of any other spot obtained from the Test solution does not exceed that of the principal spot obtained from the Diluted standard solution (0.5%); and the total of the estimated sizes and intensities of all of the other spots obtained from the Test solution does not exceed four times that of the principal spot obtained from the Diluted standard solution (2.0%)

供试品溶液的主斑点的Rf值应与对照溶液的主斑点的Rf值相符，供试品溶液的任意杂质斑点的大小和强度不得超过稀对照溶液斑点的大小和强度（0.5%），供试品溶液中所有杂质斑点的大小和强度不得超过稀对照溶液斑点的大小和强度的4倍（2.0%）。

Assay

含量

99.55%

98.5% ~ 101.5%

Conclusion：Conforms to USP40

      结论 ：符合USP40标准.