甲磺酸罗哌卡因854056-07-8
|
Product 产品名称: |
Ropivacaine MESYLATE 甲磺酸罗哌卡因 |
|||||
|
batch No. 批号: |
23070301 |
Mfg. date 生产日期 |
2023.07.03 |
|||
|
Test Date 批准日期: |
2023.07.05 |
Exp. date 有效期至 |
2025.07.02 |
|||
|
Tests 项目 |
Results 结果 |
Specifications 标准 |
|
|||
|
Appearance 性状 |
Complies 符合规定 |
White or off white crystalline powder 白色或类白色结晶性粉末 |
|
|||
|
Identification 鉴别 |
Complies 符合规定 |
(1):The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. 供试品主峰的保留时间应与对照品一致 |
|
|||
|
Complies 符合规定 |
(2): By IR, To match with working standard 红外吸收图谱应与对照品一致 |
|
||||
|
Colour 颜色 |
Complies 符合规定 |
Should be to match with the standard 应符合规定 |
|
|||
|
Clarity 澄清度 |
Complies 符合规定 |
Should be to match with the standard 应符合规定 |
|
|||
|
Specific rotation比旋度 |
-7.29° |
-6°~ -8° |
|
|||
|
Melting point熔点 |
153.5~154.5℃ |
150~155℃ |
|
|||
|
pH酸度 |
4.50 |
4.0 ~ 7.0 |
|
|||
|
Dextrotation右旋体含量 |
Complies |
£1.0% |
|
|||
|
Relative Substance 有关物质 |
0.10% |
£1.0% |
|
|||
|
2，6－dimethylaniline 2,6-二甲基苯胺 |
＜0.01% |
£0.01% |
|
|||
|
Loss on drying 干燥失重 |
0.14% |
£0.5% |
|
|||
|
Residue on ignition 炽灼残渣 |
0.03% |
£0.1% |
|
|||
|
Heavy metal 重金属 |
＜10 ppm |
£ 10 ppm |
|
|||
|
Assay 含量（HPLC） |
99.90% |
≥99.0% |
|
|||
|
Conclusion 结论 ： Conforms to Enterprise Standard 本品符合企业标准 |
||||||
