品    名

紅霉素（按美國(guó)藥典38版檢驗(yàn)）

批    號(hào)

220108

數(shù)    量

525kg

報(bào)告日期

2022.01.25

生產(chǎn)日期

2022.01.08

有效期至

2024.12

檢驗(yàn)結(jié)果

檢驗(yàn)項(xiàng)目                                  標(biāo)準(zhǔn)規(guī)定                                  結(jié)果   

性狀                                     白色結(jié)晶粉末                         白色結(jié)晶粉末

鑒別                                      應(yīng)符合規(guī)定                             符合規(guī)定

比旋度                                     -71~-78°                                -74°        

結(jié)晶度                                    應(yīng)符合規(guī)定                              符合規(guī)定  

 水分                                        ≤10.0%                                 3.6 %

熾灼殘?jiān)?                                   ≤0.2%                                  0.1%     

硫氰酸鹽                                    ≤0.3%                                   0.1%

有關(guān)物質(zhì)

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(gè)有關(guān)物質(zhì)                             ≤3.0%                                  2.4%

含量測(cè)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(jié)論：本品按《美國(guó)藥典》38標(biāo)準(zhǔn)檢驗(yàn)，結(jié)果符合規(guī)定。