品    名

紅霉素（按美國藥典38版檢驗）

批    號

220108

數    量

525kg

報告日期

2022.01.25

生產日期

2022.01.08

有效期至

2024.12

檢驗結果

檢驗項目                                  標準規定                                  結果   

性狀                                     白色結晶粉末                         白色結晶粉末

鑒別                                      應符合規定                             符合規定

比旋度                                     -71~-78°                                -74°        

結晶度                                    應符合規定                              符合規定  

 水分                                        ≤10.0%                                 3.6 %

熾灼殘渣                                    ≤0.2%                                  0.1%     

硫氰酸鹽                                    ≤0.3%                                   0.1%

有關物質

紅霉素A烯醇醚                              ≤3.0%                                  0.2%

紅霉素B                                     ≤12.0%                                 2.1%

紅霉素C                                     ≤ 5.0%                                 3.5%

任一單個有關物質                             ≤3.0%                                  2.4%

含量測定（干品）

ASSAY                                    85.0%~100.5%                              98.6%

紅霉素A                                                                             93.0%

殘留溶劑             

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%

結論：本品按《美國藥典》38標準檢驗，結果符合規定。