依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101670311661971662201663741664231664490.21
210.081695011699691697350.20
单位质量响应值RSD%判断
16480.1016838.791.53数据可信
长期36月-供试品溶液-依折麦布-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121118474418465818470199.54100.601.9398.57%~102.64%
2189511190259189885102.34
3188773189486189130101.93
418097918061718079897.44
5185442186153185798100.14
6189377189997189687102.23
20240302211187756187768187762101.19101.230.67100.52%~101.94%
2188388188552188470101.58
3188335188192188264101.46
4186483186514186498100.51
5189359189936189648102.21
6186412186288186350100.43
2024030321118114318087818101097.5598.621.5097.07%~100.16%
2187965188021187993101.32
318406618421618414199.24
418077818061318069697.39
518159118236118197698.08
618188118221618204898.11
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.381541371539541537961540731538751539670.10
211.411560871565641563260.22
单位质量响应值RSD%判断
13529.6113700.790.89数据可信
长期36月-供试品溶液-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121115853915894015874096.5199.361.7697.53%~101.18%
2165690165508165599100.68
316376316359816368099.51
416145516122516134098.09
5164973165333165153100.41
6165988166112166050100.95
20240302211170706170709170708103.79103.100.71102.34%~103.87%
2168719168845168782102.62
3169811170462170136103.44
4168063168146168104102.20
5170835171224171030103.98
6168842168684168763102.60
2024030321116308716308516308699.1599.152.6396.42%~101.88%
216423516464016443899.97
3167357167778167568101.88
415654315678315666395.25
515946115980915963597.05
6166938167292167115101.60
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101672111670081675241672651671881672390.12
210.081694961700741697850.25
单位质量响应值RSD%判断
16558.3216843.751.21数据可信
中间条件36月-供试品溶液-依折麦布-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117728017764217746195.4099.582.2597.24%~101.93%
2190095189637189866102.07
3187045186696186870100.46
418570018572518571299.84
518517318489918503699.47
6186451186538186494100.26
20240302211189195189097189146101.6899.901.3398.51%~101.30%
2186767186945186856100.45
318259118272418265898.19
4187022187139187080100.57
5186085186068186076100.03
618328218322018325198.51
2024030321118255618261818258798.1698.811.2197.56%~100.05%
218350018319318334698.56
318075518050018062897.10
4186500187138186819100.43
518541118593818567499.81
618375618374218374998.78
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.381549841549521555721553541552161552160.17
211.411562381565851564120.16
单位质量响应值RSD%判断
13639.3713708.330.36数据可信
中间条件36月-供试品溶液-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121116054016135016094597.4399.621.4398.13%~101.11%
216471916486016479099.76
316424916428416426699.44
416394016414516404299.30
516533716472416503099.90
6168051168505168278101.87
20240302211170860170548170704103.34102.252.1899.92%~104.58%
2166047166094166070100.53
3166748166918166833100.99
4174736173345174040105.36
5171422171163171292103.69
616421216475116448299.57
2024030321116352616295916324298.8297.481.3896.08%~98.89%
215715715680515698195.03
316100116055916078097.33
416017816115916066897.26
516216616258716237698.29
616209616224016216898.17
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101666191669881670951673691681211672380.34
210.081680671690581685620.42
单位质量响应值RSD%判断
16558.2216722.420.70数据可信
长期36月-供试品溶液-依折麦布-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117901317926917914196.6598.972.0196.89%~101.05%
218242318205418223898.32
318291318289818290698.68
418035418109718072697.50
5188462188790188626101.77
6187214186841187028100.90
2024030221118266918280818273898.5999.911.5098.35%~101.48%
218202418245118223898.32
318358118407518382899.18
4186121185697185909100.30
5186715187286187000100.89
6189307189510189408102.19
2024030321117754317844617799496.0398.001.2396.74%~99.25%
218180118146518163397.99
318247918344518296298.71
418348618436218392499.23
517983918056218020097.22
618304218325718315098.81
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.383112013113353114843114993114093113860.04
211.413126933142243134580.35
单位质量响应值RSD%判断
27362.5727472.220.29数据可信
长期36月-供试品溶液-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121131932032068232000196.6198.061.6496.37%~99.74%
232033031933731983496.56
332268632274332271497.43
432566032601832583998.37
532586332669332627898.50
6333921334232334076100.86
2024030221132964333110433037499.7497.732.8894.78%~100.68%
232422032488032455097.98
330713030838030775592.91
431960231975431967896.51
532530232594632562498.31
6334281334354334318100.93
2024030321132056432254432155497.0899.271.2997.93%~100.60%
233074033013633043899.76
3330883331822331352100.04
4331374332239331806100.17
532526132631832579098.36
6332106331623331864100.19
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101675801682801688691692011695751687010.47
210.081697201713601705400.68
单位质量响应值RSD%判断
16703.0716918.650.91数据可信
中间条件36月-供试品溶液-依折麦布-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121118575118677018626099.47100.551.0499.45%~101.64%
2187852187417187634100.21
318623518566118594899.31
4189643190585190114101.53
5188814189395189104100.99
6190759190350190554101.77
2024030221118248418256718252697.4898.890.7998.08%~99.70%
218637518623418630499.50
318483918514418499298.80
418533818452518493298.76
518595018716218655699.63
618553918585018569499.17
2024030321117608917593317601194.0096.892.0294.84%~98.94%
218531418561118546299.05
318313818258518286297.66
417848517831017839895.27
518474018444118459098.58
618140718108518124696.79
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.383116173129973139033141733151243135630.43
211.413151233180003165620.65
单位质量响应值RSD%判断
27553.8727744.260.49数据可信
中间条件36月-供试品溶液-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121132162932258732210896.4398.242.2195.96%~100.52%
232064131991332027795.88
332685532690732688197.86
432911332995032953298.65
532981332877132929298.58
6340651340914340782102.02
2024030221132030732025432028095.8897.111.2595.84%~98.38%
232603132596432599897.60
331856531961531909095.53
432356432423032389796.97
532872432873632873098.41
632873532781632827698.28
2024030321131917631963531940695.6298.321.7896.49%~100.16%
2336514336391336452100.73
333014232962132988298.76
432507332521332514397.34
533232733123733178299.33
632789232778732784098.15
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