依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081704861702431702841705061707241704490.12
211.041713101718141715620.21
单位质量响应值RSD%判断
15383.4815540.040.72数据可信
加速6月-供试品溶液-2023122221批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1127196-12719670.44373.7410.8970.4473.7410.90
2136372-13637275.52575.53
3128096-12809670.94270.94
4134616-13461674.55374.55
5158174-15817487.59987.60
6114404-11440463.35963.36
10min1163139-16313990.34994.053.1290.7494.463.12
2175564-17556497.23097.65
3163310-16331090.44490.84
4171391-17139194.91995.33
5173032-17303295.82896.31
6172542-17254295.55795.91
15min1173399-17339996.03195.462.2696.9296.392.25
2177229-17722998.15299.11
3165758-16575891.80092.70
4170815-17081594.60095.54
5172496-17249695.53196.55
6174506-17450696.64497.53
20min1174282-17428296.52096.512.1597.9597.972.15
2178423-17842398.814100.32
3167451-16745192.73794.14
4174025-17402596.37897.85
5174640-17464096.71998.27
6176736-17673697.87999.30
30min1174279-17427996.51995.772.3198.4897.762.29
2176424-17642497.70799.76
3165606-16560691.71593.64
4171954-17195495.23197.23
5173071-17307195.85097.94
6176177-17617797.57099.53
45min1173014-17301495.81894.311.7598.3296.841.74
2172809-17280995.70598.30
3166095-16609591.98694.42
4167205-16720592.60195.13
5170664-17066494.51797.14
6171998-17199895.25597.76
60min1175328-17532897.10094.552.43100.1397.602.40
2173030-17303095.82798.96
3163122-16312290.34093.28
4171295-17129594.86697.91
5170030-17003094.16597.31
6171503-17150394.98198.02
极限1172916-17291695.76493.872.3899.3397.452.36
2172847-17284795.72699.39
3162087-16208789.76693.21
4168778-16877893.47297.05
5169184-16918493.69797.36
6171140-17114094.78098.34
依折麦布瑞舒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ZT-705-231101-1-D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(%)100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%
111.071859121856321859441863001862331860040.15
211.071851411867371859390.61
单位质量响应值RSD%判断
16802.5316796.660.03数据可信
加速6月-供试品溶液-2023122221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1117266-11726662.82351.9917.2562.8251.9917.25
287599-8759946.92946.93
379782-7978242.74142.74
479951-7995142.83242.83
5104770-10477056.12856.13
6112909-11290960.48860.49
10min1168173-16817390.09585.594.3490.4485.884.38
2156477-15647783.82984.09
3151725-15172581.28381.52
4154930-15493083.00083.24
5159103-15910385.23685.55
6168136-16813690.07590.41
15min1173998-17399893.21592.531.5794.0793.301.60
2172842-17284292.59693.32
3173632-17363293.01993.71
4167929-16792989.96490.66
5172002-17200292.14692.93
6175954-17595494.26395.10
20min1174757-17475793.62295.351.3694.9996.631.34
2179076-17907695.93697.18
3179986-17998696.42397.63
4175411-17541193.97295.17
5178053-17805395.38896.69
6180585-18058596.74498.10
30min1174749-17474993.61895.521.7195.5197.321.68
2179674-17967496.25698.03
3181249-18124997.10098.84
4174571-17457193.52295.24
5178224-17822495.47997.31
6181299-18129997.12799.02
45min1174410-17441093.43694.252.2995.8496.592.24
2175612-17561294.08096.39
3182748-18274897.903100.18
4170342-17034291.25793.50
5175833-17583394.19996.56
6176622-17662294.62197.06
60min1173619-17361993.01294.251.2095.9497.111.15
2175735-17573594.14696.98
3179735-17973596.28999.11
4174605-17460593.54196.29
5175538-17553894.04096.92
6176332-17633294.46697.43
极限1173945-17394593.18793.761.0996.6397.151.09
2175466-17546694.00297.36
3177430-17743095.05498.41
4171932-17193292.10995.38
5175227-17522793.87497.28
6176131-17613194.35897.85
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081743601743501744391746231745641744670.08
211.041725881727801726840.08
单位质量响应值RSD%判断
15746.1215641.670.48数据可信
长期6月-供试品溶液-2023122221批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1128742-12874270.24474.6714.8470.2474.6814.83
2134338-13433873.29773.30
3141544-14154477.22977.23
4102775-10277556.07656.08
5156005-15600585.11985.12
6157771-15777186.08386.08
10min1166416-16641690.79993.524.6591.1993.934.68
2177655-17765596.93297.34
3176051-17605196.05696.49
4157557-15755785.96686.28
5173373-17337394.59595.07
6177327-17732796.75397.23
15min1172861-17286194.31696.121.6795.2197.051.66
2179700-17970098.04798.99
3176655-17665596.38697.35
4176263-17626396.17296.96
5172686-17268694.22095.22
6178834-17883497.57598.59
20min1169182-16918292.30996.112.3293.7397.582.30
2179336-17933697.84999.34
3180184-18018498.31199.81
4177436-17743696.81298.14
5173722-17372294.78696.31
6176984-17698496.56698.12
30min1167882-16788291.59996.262.8893.5398.262.86
2181001-18100198.757100.79
3178580-17858097.43699.48
4177424-17742496.80698.67
5173074-17307494.43296.48
6180600-18060098.538100.63
45min1167746-16774691.52595.062.5093.9797.602.46
2176433-17643396.26598.85
3177697-17769796.95599.54
4177930-17793097.08299.48
5169810-16981092.65195.22
6175782-17578295.91098.55
60min1168498-16849891.93594.701.8094.8897.771.78
2176228-17622896.15399.27
3174851-17485195.40298.53
4176417-17641796.25699.19
5171219-17121993.42096.51
6174220-17422095.05798.23
极限1170591-17059193.07793.621.6096.5497.211.54
2175289-17528995.64199.29
3172161-17216193.93497.59
4173441-17344194.63298.11
5167350-16735091.30994.92
6170685-17068593.12996.83
依折麦布瑞舒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ZT-705-231101-1-D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(%)100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%
111.071868511873121872331871771875811872310.15
211.071875371883531879450.31
单位质量响应值RSD%判断
16913.3716977.870.27数据可信
长期6月-供试品溶液-2023122221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1108640-10864057.70059.9619.7857.7059.9619.78
285077-8507745.18545.19
3112114-11211459.54559.55
494005-9400549.92749.93
5140142-14014274.43174.43
6137390-13739072.97072.97
10min1166684-16668488.52889.633.2988.8589.963.34
2161932-16193286.00486.26
3172245-17224591.48191.81
4163989-16398987.09787.37
5171028-17102890.83591.25
6176660-17666093.82694.23
15min1175098-17509892.99793.631.4793.8194.461.49
2175530-17553093.22693.96
3175253-17525393.07993.92
4176289-17628993.62994.39
5174221-17422192.53193.45
6181373-18137396.32997.26
20min1171927-17192791.31394.231.7892.6495.581.78
2177611-17761194.33195.58
3180652-18065295.94797.30
4177335-17733594.18595.47
5176663-17666393.82895.26
6180287-18028795.75397.21
30min1170997-17099790.81995.092.6792.6596.972.65
2181854-18185496.58598.36
3179663-17966395.42197.31
4179221-17922195.18796.99
5177360-17736094.19896.15
6185184-18518498.354100.35
45min1171072-17107290.85994.012.1493.2096.412.10
2177385-17738594.21196.52
3178539-17853994.82497.24
4180791-18079196.02098.35
5173999-17399992.41394.89
6180213-18021395.71398.25
60min1171576-17157691.12693.361.3293.9796.281.31
2177380-17738094.20997.04
3175574-17557493.25096.20
4177527-17752794.28797.15
5175113-17511393.00595.99
6177494-17749494.26997.34
极限1174012-17401292.42092.631.2495.7796.071.15
2177820-17782094.44297.80
3173133-17313391.95395.42
4175471-17547193.19596.59
5171472-17147291.07194.58
6174490-17449092.67496.27
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081712661713391712831716061714361713860.09
211.041730461735841733150.22
单位质量响应值RSD%判断
15468.0515698.821.05数据可信
中间条件6月-供试品溶液-2023122221批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1131411-13141172.21176.448.3072.2176.448.30
2145805-14580580.12180.12
3153034-15303484.09384.09
4148972-14897281.86181.86
5125382-12538268.89868.90
6130061-13006171.47071.47
10min1170756-17075693.83293.720.9294.2394.150.91
2170480-17048093.68094.13
3170068-17006893.45493.92
4171421-17142194.19794.65
5172658-17265894.87795.26
6167980-16798092.30692.70
15min1174547-17454795.91594.841.8696.8495.781.85
2176008-17600896.71897.68
3171295-17129594.12895.11
4174158-17415895.70196.68
5172526-17252694.80595.71
6166982-16698291.75892.67
20min1174515-17451595.89794.581.4697.3596.051.45
2173074-17307495.10696.61
3171573-17157394.28195.79
4172023-17202394.52896.04
5173999-17399995.61497.05
6167538-16753892.06493.48
30min1169767-16976793.28893.791.1395.2895.781.14
2172225-17222594.63996.67
3170091-17009193.46695.50
4172541-17254194.81396.85
5171890-17189094.45596.42
6167519-16751992.05393.98
45min1169226-16922692.99194.012.7895.5096.532.73
2171494-17149494.23796.79
3167140-16714091.84594.40
4179976-17997698.898101.46
5171341-17134194.15396.65
6167292-16729291.92894.37
60min1171533-17153394.25993.131.3497.2896.171.34
2171083-17108394.01297.09
3167830-16783092.22495.29
4171638-17163894.31797.43
5168583-16858392.63895.65
6166208-16620891.33394.29
极限1172217-17221794.63593.441.7798.1897.001.74
2170772-17077293.84197.44
3166667-16666791.58595.16
4171832-17183294.42398.06
5172905-17290595.01398.54
6165908-16590891.16894.63
依折麦布瑞舒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ZT-705-231101-1-D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(%)100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%
111.071863321861321867541866571867131865180.15
211.071872411880681876540.32
单位质量响应值RSD%判断
16848.9616951.580.43数据可信
中间条件6月-供试品溶液-2023122221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174384-7438439.61353.4320.8239.6153.4320.82
2116613-11661362.10162.10
3121897-12189764.91564.92
4111286-11128659.26459.26
574832-7483239.85139.85
6102953-10295354.82754.83
10min1149456-14945679.59187.564.9779.8187.855.01
2171702-17170291.43891.78
3169403-16940390.21490.57
4165518-16551888.14588.47
5161392-16139285.94886.17
6168993-16899389.99690.30
15min1168951-16895189.97392.892.5790.6493.682.62
2181884-18188496.86197.71
3175803-17580393.62294.48
4175517-17551793.47094.29
5171386-17138691.27091.97
6173043-17304392.15292.96
20min1174528-17452892.94394.301.2494.1195.601.29
2180843-18084396.30697.70
3177789-17778994.68096.06
4176830-17683094.16995.51
5177026-17702694.27495.48
6175465-17546593.44294.76
30min1173292-17329292.28594.581.5093.9696.401.56
2181329-18132996.56598.49
3177893-17789394.73596.64
4178993-17899395.32197.18
5177420-17742094.48396.21
6176658-17665894.07895.91
45min1174224-17422492.78194.271.2994.9796.621.32
2179954-17995495.83398.30
3174651-17465193.00995.44
4178874-17887495.25897.65
5177553-17755394.55496.81
6176915-17691594.21496.57
60min1176450-17645093.96793.941.2296.6796.811.25
2179359-17935995.51698.51
3175313-17531393.36196.31
4178422-17842295.01797.94
5173647-17364792.47495.25
6175224-17522493.31496.20
极限1177281-17728194.40994.341.2397.6497.731.17
2178913-17891395.27898.80
3174297-17429792.82096.29
4178547-17854795.08498.53
5179175-17917595.41898.71
6174691-17469193.03096.43
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