當(dāng)前頁面： 首頁 > 新聞中心新聞中心
|
質(zhì)檢報告單——CERTIFICATE OF ANALYSIS |
|
|
|||||
|
產(chǎn)品名稱 |
羅紅霉素 |
|
|
產(chǎn)品批號 |
20230909 |
|
|
|
Product Name |
Roxithromycin |
|
Batch No. |
|
|||
|
|
|
|
|
||||
|
批次數(shù)量 |
1321.2KG |
|
|
生產(chǎn)日期 |
2023-09-14 |
|
|
|
Quantity |
|
|
Man. Date |
|
|||
|
|
|
|
|
|
|
||
|
包裝規(guī)格 |
25KG/紙桶/Drum |
檢測日期 |
2023-09-24 |
|
|||
|
Packaging |
Test Date |
|
|||||
|
|
|
|
|
|
|
||
|
有效日期 |
2025-09-13 |
|
|
報告日期 |
2023-09-27 |
|
|
|
Expiry Date |
|
|
Report Date |
|
|||
|
|
|
|
|
|
|
||
|
檢驗項目 |
檢驗指標(biāo) |
|
|
|
檢驗結(jié)果 |
|
|
|
Test Items |
Standard |
|
|
|
Test Results |
|
|
|
外觀 |
白色或類白色結(jié)晶性粉末 |
|
符合規(guī)定 |
|
|||
|
Appearance |
White or off-white crystalline powder |
|
Complies |
|
|||
|
溶解性 |
符合規(guī)定 |
|
|
|
符合規(guī)定 |
|
|
|
Solubility |
Complies |
|
|
|
Complies |
|
|
|
鑒別 |
符合規(guī)定 |
|
|
|
符合規(guī)定 |
|
|
|
Identification |
Complies |
|
|
|
Complies |
|
|
|
溶液外觀 |
澄清無色 |
|
|
|
符合規(guī)定 |
|
|
|
Solution of appearance |
Clear and colourless |
|
|
Complies |
|
||
|
比旋度 |
-93° ~ -96° |
|
|
|
-94° |
|
|
|
Specific rotation |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
雜質(zhì) A Impurity A≤0.5% |
|
0.14% |
|
|||
|
|
雜質(zhì) B Impurity B≤0.5% |
|
ND |
|
|||
|
|
雜質(zhì) C Impurity C≤0.5% |
|
0.15% |
|
|||
|
|
雜質(zhì) D Impurity D≤0.5% |
|
0.079% |
|
|||
|
有關(guān)物質(zhì) HPLC |
雜質(zhì) E Impurity E≤0.5% |
|
ND |
|
|||
|
雜質(zhì) F Impurity F≤0.5% |
|
0.17% |
|
||||
|
Related substances |
|
|
|||||
|
雜質(zhì) G Impurity G≤1.0% |
|
0.088% |
|
||||
|
|
|
|
|||||
|
|
雜質(zhì) H Impurity H≤0.5% |
|
0.095% |
|
|||
|
|
雜質(zhì) I Impurity I≤0.5% |
|
0.36% |
|
|||
|
|
雜質(zhì) J Impurity J≤0.5% |
|
0.11% |
|
|||
|
|
總雜質(zhì) Total impurities≤3.0% |
|
1.4% |
|
|||
|
|
甲醇 Methanol≤3000ppm |
|
222ppm |
|
|||
|
|
丙酮 Acetone≤5000ppm |
|
21ppm |
|
|||
|
殘留溶劑 |
Thiethy lamine≤320ppm |
|
ND |
|
|||
|
Residual solvent |
二氯甲烷 Methylene chloride≤600ppm |
|
ND |
|
|||
|
|
N,N-二甲基甲酰胺 N,N-Dimethylformamide≤880ppm |
ND |
|
||||
|
|
醋酸 Acetic Acid≤5000ppm |
|
54ppm |
|
|||
|
水分 |
≤3.0% |
|
|
|
|
2.1% |
|
|
Water |
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
硫酸灰分 |
|
≤0.1% |
|
0.06% |
|
|
|
Sulphated ash |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
含量（無水物） |
|
96.0~102% |
|
97.5% |
|
|
|
Assay（Anhydrous） |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
結(jié)論 |
|
本品符合 EP10.0 質(zhì)量標(biāo)準(zhǔn) |
|
|
|
|
|
Conclusion |
|
Complies with EP10.0 standard |
|
|
|
|
|
Tester(化驗)：Zhangmin |
Re-tester(復(fù)核)：Wanghong |
Director(主管)：Liliang |
|
|||
