罗红霉素,80214-83-1,质检单
|
质检报告单——CERTIFICATE OF ANALYSIS |
|
|
|||||
|
产品名称 |
罗红霉素 |
|
|
产品批号 |
20230909 |
|
|
|
Product Name |
Roxithromycin |
|
Batch No. |
|
|||
|
|
|
|
|
||||
|
批次数量 |
1321.2KG |
|
|
生产日期 |
2023-09-14 |
|
|
|
Quantity |
|
|
Man. Date |
|
|||
|
|
|
|
|
|
|
||
|
包装规格 |
25KG/纸桶/Drum |
检测日期 |
2023-09-24 |
|
|||
|
Packaging |
Test Date |
|
|||||
|
|
|
|
|
|
|
||
|
有效日期 |
2025-09-13 |
|
|
报告日期 |
2023-09-27 |
|
|
|
Expiry Date |
|
|
Report Date |
|
|||
|
|
|
|
|
|
|
||
|
检验项目 |
检验指标 |
|
|
|
检验结果 |
|
|
|
Test Items |
Standard |
|
|
|
Test Results |
|
|
|
外观 |
白色或类白色结晶性粉末 |
|
符合规定 |
|
|||
|
Appearance |
White or off-white crystalline powder |
|
Complies |
|
|||
|
溶解性 |
符合规定 |
|
|
|
符合规定 |
|
|
|
Solubility |
Complies |
|
|
|
Complies |
|
|
|
鉴别 |
符合规定 |
|
|
|
符合规定 |
|
|
|
Identification |
Complies |
|
|
|
Complies |
|
|
|
溶液外观 |
澄清无色 |
|
|
|
符合规定 |
|
|
|
Solution of appearance |
Clear and colourless |
|
|
Complies |
|
||
|
比旋度 |
-93° ~ -96° |
|
|
|
-94° |
|
|
|
Specific rotation |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
杂质 A Impurity A≤0.5% |
|
0.14% |
|
|||
|
|
杂质 B Impurity B≤0.5% |
|
ND |
|
|||
|
|
杂质 C Impurity C≤0.5% |
|
0.15% |
|
|||
|
|
杂质 D Impurity D≤0.5% |
|
0.079% |
|
|||
|
有关物质 HPLC |
杂质 E Impurity E≤0.5% |
|
ND |
|
|||
|
杂质 F Impurity F≤0.5% |
|
0.17% |
|
||||
|
Related substances |
|
|
|||||
|
杂质 G Impurity G≤1.0% |
|
0.088% |
|
||||
|
|
|
|
|||||
|
|
杂质 H Impurity H≤0.5% |
|
0.095% |
|
|||
|
|
杂质 I Impurity I≤0.5% |
|
0.36% |
|
|||
|
|
杂质 J Impurity J≤0.5% |
|
0.11% |
|
|||
|
|
总杂质 Total impurities≤3.0% |
|
1.4% |
|
|||
|
|
甲醇 Methanol≤3000ppm |
|
222ppm |
|
|||
|
|
丙酮 Acetone≤5000ppm |
|
21ppm |
|
|||
|
残留溶剂 |
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（无水物） |
|
96.0~102% |
|
97.5% |
|
|
|
Assay（Anhydrous） |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
结论 |
|
本品符合 EP10.0 质量标准 |
|
|
|
|
|
Conclusion |
|
Complies with EP10.0 standard |
|
|
|
|
|
Tester(化验)：Zhangmin |
Re-tester(复核)：Wanghong |
Director(主管)：Liliang |
|
|||
