品    名

红霉素（按美国药典38版检验）

批    号

220108

数    量

525kg

报告日期

2022.01.25

生产日期

2022.01.08

有效期至

2024.12

检验结果

检验项目                                  标准规定                                  结果   

性状                                     白色结晶粉末                         白色结晶粉末

鉴别                                      应符合规定                             符合规定

比旋度                                     -71~-78°                                -74°        

结晶度                                    应符合规定                              符合规定  

 水分                                        ≤10.0%                                 3.6 %

炽灼残渣                                    ≤0.2%                                  0.1%     

硫氰酸盐                                    ≤0.3%                                   0.1%

有关物质

红霉素A烯醇醚                              ≤3.0%                                  0.2%

红霉素B                                     ≤12.0%                                 2.1%

红霉素C                                     ≤ 5.0%                                 3.5%

任一单个有关物质                             ≤3.0%                                  2.4%

含量测定（干品）

ASSAY                                    85.0%~100.5%                              98.6%

红霉素A                                                                             93.0%

残留溶剂             

乙醇：0.5%max                                                                      0.0022%

丙酮：0.5%max                                                                      0.0045%

丙醇：0.5%max                                                                      0.0000%

乙酸正丁酯：0.5%max                                                                0.0000%

结论：本品按《美国药典》38标准检验，结果符合规定。