依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.871629751621181627821626141629751626930.22
29.821640491657431648960.73
单位质量响应值RSD%判断
16483.5916791.851.32数据可信
供试品溶液-2023120821批-依折麦布-shui(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174316-7431640.07139.4122.1740.0739.4122.16
287547-8754747.20547.21
369678-6967837.57037.57
463220-6322034.08834.09
594122-9412250.75150.75
649644-4964426.76826.77
10min1166545-16654589.80184.7211.1490.0284.9411.17
2171435-17143592.43892.70
3155336-15533683.75783.97
4145454-14545478.42978.62
5174865-17486594.28794.57
6129120-12912069.62269.77
15min1178036-17803695.99794.334.9496.7295.025.01
2179054-17905496.54697.32
3176498-17649895.16895.84
4170520-17052091.94492.57
5185363-18536399.948100.75
6160240-16024086.40286.94
20min1174588-17458894.13895.372.4395.3996.582.51
2177178-17717895.53496.85
3177780-17778095.85997.06
4176412-17641295.12196.26
5184136-18413699.286100.65
6171120-17112092.26893.28
30min1173260-17326093.42294.831.2295.2096.571.25
2175518-17551894.63996.48
3175012-17501294.36796.10
4177943-17794395.94797.61
5178890-17889096.45898.37
6174616-17461694.15395.68
45min1168966-16896691.10792.331.4393.4094.601.48
2171863-17186392.66995.04
3168837-16883791.03793.30
4171784-17178492.62694.82
5175434-17543494.59497.04
6170539-17053991.95594.01
60min1168225-16822590.70790.871.6893.5193.651.76
2167645-16764590.39493.28
3169847-16984791.58294.35
4168352-16835290.77693.49
5172846-17284693.19996.17
6164226-16422688.55191.11
极限1159566-15956686.03887.063.0889.3590.353.02
2155042-15504283.59986.98
3164944-16494488.93892.21
4165027-16502788.98392.20
5167216-16721690.16393.65
6156962-15696284.63487.69
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.851507211501821507761508191502571505510.21
210.841517891530001523940.57
单位质量响应值RSD%判断
13875.6714058.490.93数据可信
供试品溶液-2023120821批-阿托伐他汀-shui(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100038-10003859.16462.8333.8659.1662.8333.86
2148047-14804787.55787.56
3109160-10916064.55964.56
4128120-12812075.77275.77
5110401-11040165.29365.29
641625-4162524.61824.62
10min1141726-14172683.81986.4412.8084.1586.7912.88
2165061-16506197.62098.11
3149375-14937588.34388.70
4160645-16064595.00895.43
5147888-14788887.46387.83
6112285-11228566.40766.54
15min1154590-15459091.42792.525.1692.2293.345.30
2164943-16494397.55098.58
3158303-15830393.62394.47
4164411-16441197.23598.18
5152949-15294990.45791.31
6143394-14339484.80685.31
20min1156138-15613892.34394.023.5493.6495.363.65
2163177-16317796.50698.08
3160376-16037694.84996.22
4167263-16726398.922100.41
5153225-15322590.62091.97
6153676-15367690.88691.86
30min1157544-15754493.17495.043.2694.9996.903.33
2164636-16463697.36899.48
3161940-16194095.77497.67
4168046-16804699.385101.42
5153604-15360490.84492.70
6158420-15842093.69295.17
45min1162060-16206095.84595.452.1598.1897.852.23
2163794-16379496.87099.52
3159971-15997194.60997.04
4166113-16611398.242100.83
5156032-15603292.28094.64
6160417-16041794.87396.88
60min1161090-16109095.27195.831.9898.1498.762.11
2164017-16401797.002100.19
3163869-16386996.91599.87
4166199-16619998.293101.43
5157863-15786393.36396.23
6159190-15919094.14896.68
极限1161754-16175495.66494.062.3899.0697.522.35
2153913-15391391.02794.75
3160723-16072395.05498.55
4164043-16404397.018100.70
5157489-15748993.14296.53
6156357-15635792.47295.52
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.871642241649511654171656301660241652490.42
29.821632571640041636300.33
单位质量响应值RSD%判断
16742.5516662.930.34数据可信
供试品溶液-2023120822批-依折麦布-shui(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153060-5306028.49636.9825.5528.5036.9825.55
288492-8849247.52547.53
352044-5204427.95127.95
489073-8907347.83747.84
575107-7510740.33740.34
655380-5538029.74229.74
10min1131093-13109370.40574.937.2570.5675.147.30
2147704-14770479.32679.59
3135170-13517072.59472.75
4155628-15562883.58183.85
5137551-13755173.87374.10
6129999-12999969.81769.98
15min1159487-15948785.65489.153.3986.2089.773.43
2165302-16530288.77789.48
3167113-16711389.74990.31
4175905-17590594.47195.20
5166114-16611489.21389.85
6162085-16208587.04987.60
20min1170052-17005291.32891.670.5192.3592.790.50
2169568-16956891.06892.27
3171052-17105291.86592.92
4171251-17125191.97293.23
5170310-17031091.46692.60
6171902-17190292.32193.36
30min1171355-17135592.02891.360.6593.5692.990.67
2169760-16976091.17192.87
3169828-16982891.20892.78
4171284-17128491.99093.76
5170038-17003891.32092.96
6168435-16843590.45992.01
45min1158293-15829385.01387.742.0887.0689.872.03
2162002-16200287.00589.21
3162929-16292987.50289.58
4163507-16350787.81390.09
5164875-16487588.54890.69
6168581-16858190.53892.59
60min1154147-15414782.78683.633.1085.3086.253.00
2146684-14668478.77881.47
3156629-15662984.11986.68
4159298-15929885.55288.32
5158490-15849085.11887.76
6159039-15903985.41387.97
极限1152471-15247181.88682.091.8684.8685.171.81
2149840-14984080.47383.60
3149647-14964780.36983.40
4154901-15490183.19186.43
5153315-15331582.33985.45
6156882-15688284.25587.28
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.851529261527761531801531761532591530630.14
210.841513361520991517180.36
单位质量响应值RSD%判断
14107.1913996.130.56数据可信
供试品溶液-2023120822批-阿托伐他汀-shui(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114142-11414267.09759.8635.4667.1059.8635.46
292529-9252954.39254.39
3114435-11443567.27067.27
4148655-14865587.38587.39
5102067-10206759.99960.00
639157-3915723.01823.02
10min1155972-15597291.68789.189.1992.0689.519.29
2149784-14978488.04988.35
3157056-15705692.32492.70
4163343-16334396.02096.51
5159321-15932193.65593.99
6124733-12473373.32373.45
15min1158893-15889393.40494.903.0994.2995.733.19
2156639-15663992.07992.87
3163666-16366696.20997.10
4167901-16790198.69999.72
5165602-16560297.34898.20
6155929-15592991.66192.20
20min1162252-16225295.37895.501.3596.7896.861.31
2158487-15848793.16594.47
3163109-16310995.88297.30
4162108-16210895.29496.86
5164246-16424696.55097.94
6164570-16457096.74197.79
30min1162788-16278895.69395.520.9497.6297.401.09
2160906-16090694.58796.41
3162918-16291895.77097.72
4164304-16430496.58598.68
5163593-16359396.16798.10
6160423-16042394.30395.89
45min1154773-15477390.98294.842.4193.4497.252.30
2159199-15919993.58495.93
3162311-16231195.41397.90
4162095-16209595.28697.92
5163798-16379896.28798.75
6165811-16581197.47099.58
60min1156187-15618791.81393.833.5094.7896.773.45
2149766-14976688.03890.90
3162236-16223695.36998.38
4163917-16391796.35799.52
5163606-16360696.17499.17
6162021-16202195.24297.89
极限1158019-15801992.89094.251.5496.3797.711.50
2157354-15735492.49995.85
3159553-15955393.79297.34
4162895-16289595.75699.45
5160914-16091494.59298.13
6163226-16322695.95199.13
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.871626611632321636751647121649181638400.59
29.821623201635971629580.56
单位质量响应值RSD%判断
16599.8016594.500.03数据可信
供试品溶液-2023120823批-依折麦布-shui(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100652-10065254.40039.5820.8654.4039.5820.86
264795-6479535.02035.02
376313-7631341.24541.25
461745-6174533.37133.37
559420-5942032.11532.11
676500-7650041.34641.35
10min1163556-16355688.39780.525.3988.7080.745.43
2139749-13974975.53075.73
3149030-14903080.54780.78
4146845-14684579.36679.55
5144681-14468178.19678.37
6149996-14999681.06981.30
15min1169575-16957591.65189.321.8292.4489.991.87
2160402-16040286.69387.31
3164662-16466288.99589.67
4164772-16477289.05589.68
5165400-16540089.39490.01
6166757-16675790.12890.81
20min1170075-17007591.92192.141.1093.2293.311.09
2169132-16913291.41192.51
3169442-16944291.57992.75
4168702-16870291.17992.30
5172276-17227693.11094.22
6173288-17328893.65794.84
30min1166064-16606489.75390.900.9891.5792.580.92
2167953-16795390.77492.38
3166949-16694990.23191.91
4168071-16807190.83892.47
5169756-16975691.74893.38
6170377-17037792.08493.79
45min1158402-15840285.61287.261.1687.9289.441.09
2160844-16084486.93289.04
3161683-16168387.38589.57
4161074-16107487.05689.19
5162987-16298788.09090.23
6163705-16370588.47890.69
60min1154480-15448083.49284.691.4586.2887.361.37
2155916-15591684.26886.86
3158579-15857985.70888.37
4156008-15600884.31886.93
5160303-16030386.63989.27
6154919-15491983.72986.43
极限1151404-15140481.83082.381.4285.0885.511.32
2155795-15579584.20387.26
3153223-15322382.81385.96
4151219-15121981.73084.81
5153255-15325582.83085.94
6149599-14959980.85484.02
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.851510641514391516361524681525861518390.44
210.841509681519431514560.46
单位质量响应值RSD%判断
13994.3813971.960.12数据可信
供试品溶液-2023120823批-阿托伐他汀-shui(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192183-9218354.45369.6815.6254.4569.6715.63
2127090-12709075.07375.07
3135197-13519779.86279.86
4137952-13795281.49081.49
5103189-10318960.95560.95
6112103-11210366.22066.22
10min1150687-15068789.01290.434.0189.3190.824.04
2153185-15318590.48890.91
3156573-15657392.48992.93
4157458-15745893.01293.46
5142073-14207383.92484.26
6158562-15856293.66494.03
15min1152702-15270290.20392.281.4691.0093.171.49
2155619-15561991.92692.85
3155567-15556791.89592.85
4158469-15846993.60994.58
5155970-15597092.13392.94
6158968-15896893.90494.79
20min1155514-15551491.86493.941.8393.1695.341.81
2159412-15941294.16695.60
3156851-15685192.65494.12
4158103-15810393.39394.88
5160648-16064894.89696.21
6163640-16364096.66498.07
30min1155740-15574091.99793.741.6193.8195.661.59
2158660-15866093.72295.68
3156146-15614692.23794.22
4158714-15871493.75495.76
5160386-16038694.74296.59
6162494-16249495.98797.93
45min1155419-15541991.80893.371.5894.1395.811.56
2156733-15673392.58495.06
3156046-15604692.17894.67
4158273-15827393.49496.02
5160000-16000094.51496.88
6161875-16187595.62198.10
60min1156486-15648692.43893.791.4295.2796.761.37
2158125-15812593.40696.39
3157610-15761093.10296.11
4158100-15810093.39196.44
5162942-16294296.25299.15
6159405-15940594.16297.17
极限1157459-15745993.01393.220.6296.3696.700.60
2158511-15851193.63497.14
3156133-15613392.22995.75
4158092-15809293.38796.95
5158934-15893493.88497.31
6157708-15770893.16096.69
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