當(dāng)前頁(yè)面： 首頁(yè) > 新聞中心新聞中心
|
Product 產(chǎn)品名稱(chēng) |
PRILOCAINE base 丙胺卡因 |
||
|
batch No. 批號(hào) |
23043009 |
Mfg. date 生產(chǎn)日期 |
2023-04-30 |
|
Approval Date 批準(zhǔn)日期 |
2023-05-01 |
Exp. date 有效期至 |
2026-04-29 |
|
Tests 項(xiàng)目 |
Results 結(jié)果 |
Specifications 標(biāo)準(zhǔn) |
|
|
Description性狀 |
White crystalline powder 類(lèi)白色結(jié)晶性粉末 |
White or almost white crystalline powder白色或類(lèi)白色結(jié)晶性粉末 |
|
|
Solubility溶解度 |
Complies 符合規(guī)定 |
Very soluble in alcohol and in acetone; slightly soluble in water. 在乙醇和丙酮中極易溶，在水中微溶。 |
|
|
Identification 鑒別 |
Complies 符合規(guī)定 |
By IR, to match with the working standard 紅外吸收?qǐng)D譜應(yīng)與對(duì)照品一致 |
|
|
Melting point 熔點(diǎn) |
36.9℃～38.5℃ |
36℃～39℃ |
|
|
Water 水分 |
0.04% |
≤0.5% |
|
|
Residue on ignition 熾灼殘?jiān)?/p> |
0.03% |
≤0.1% |
|
|
Related compound A 有關(guān)物質(zhì)A |
Complies 符合規(guī)定 |
≤0.01% |
|
|
Related compounds 有關(guān)物質(zhì) |
0.05% |
not more than 0.2% of any individual impurity 任一單個(gè)雜質(zhì)不得過(guò)0.2% |
|
|
Complies 符合規(guī)定 |
not more than one impurity exceeds 0.1% 超過(guò)0.1%的雜貨不得過(guò)一個(gè) |
||
|
0.15% |
not more than 0.5% of total impurities 總雜質(zhì)和不得過(guò)0.5% |
||
|
Residual solvents 溶劑殘留 |
Not detected 未檢出 |
Dichloromethane Not more than0.06% 二氯甲烷≤0.06% |
|
|
Not detected 未檢出 |
Ethanol Not more than0.5% 乙醇≤0.5% |
||
|
0.03% |
Isopropyl ether Not more than0.5% 異丙醚≤0.5% |
||
|
Assay 含量 |
99.27% |
≥99.0% （on the anhydrous basis以干品計(jì)） |
|
|
Conclusion ： Conforms to USP39 結(jié)論 ： 符合USP39標(biāo)準(zhǔn) |
|||
