Product  產(chǎn)品名稱:

Ropivacaine MESYLATE   

甲磺酸羅哌卡因

batch No. 批號(hào):

23070301

Mfg. date  生產(chǎn)日期

   2023.07.03

Test Date  批準(zhǔn)日期:

2023.07.05

Exp. date  有效期至

   2025.07.02

Tests

項(xiàng)目

Results

結(jié)果

Specifications

標(biāo)準(zhǔn)

Appearance 性狀

Complies  

符合規(guī)定

White or off white crystalline powder 

白色或類白色結(jié)晶性粉末

Identification 鑒別

Complies

符合規(guī)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.

供試品主峰的保留時(shí)間應(yīng)與對(duì)照品一致

Complies

符合規(guī)定

(2): By IR, To match with working standard

紅外吸收?qǐng)D譜應(yīng)與對(duì)照品一致

Colour 顏色

Complies

符合規(guī)定

Should be to match with the standard

應(yīng)符合規(guī)定

Clarity 澄清度

Complies

符合規(guī)定

Should be to match with the standard

應(yīng)符合規(guī)定

Specific rotation比旋度

-7.29°

-6°~  -8°

Melting point熔點(diǎn)

153.5~154.5℃

150~155℃

pH酸度

4.50

4.0 ~ 7.0

Dextrotation右旋體含量

Complies

£1.0%

Relative Substance 有關(guān)物質(zhì)

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 熾灼殘?jiān)?/p>

0.03%

£0.1%

Heavy metal 重金屬

＜10 ppm

£ 10 ppm

Assay 含量（HPLC）

99.90%

≥99.0%

Conclusion 結(jié)論 ： Conforms to Enterprise Standard 

                                本品符合企業(yè)標(biāo)準(zhǔn)