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%
111.251768791766491773401757251756281764440.43
211.331765511777071771290.47
单位质量响应值RSD%判断
15683.9115633.630.23数据可信
中间条件24月-供试品溶液-2023122121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%
5min1145724-14572479.68784.103.7379.6984.103.73
2153733-15373384.06784.07
3151275-15127582.72382.72
4163317-16331789.30889.31
5153495-15349583.93783.94
6155214-15521484.87784.88
10min1176142-17614296.32197.461.4896.7697.931.49
2175809-17580996.13996.61
3179943-17994398.39998.86
4182461-18246199.776100.27
5178688-17868897.71398.18
6176351-17635196.43596.91
15min1179732-17973298.28499.711.2999.26100.711.31
2181590-18159099.300100.30
3181831-18183199.432100.44
4186412-186412101.937102.99
5183518-183518100.354101.36
6180902-18090298.92499.93
20min1179486-17948698.14999.542.1299.67101.102.10
2178852-17885297.80399.36
3181123-18112399.045100.60
4183129-183129100.142101.76
5189275-189275103.502105.07
6180335-18033598.614100.17
30min1176795-17679596.67898.992.2098.75101.112.18
2177970-17797097.32099.42
3179862-17986298.355100.46
4180991-18099198.972101.15
5187952-187952102.779104.92
6182606-18260699.856101.96
45min1176405-17640596.46598.331.4399.07100.991.43
2178668-17866897.702100.34
3181129-18112999.048101.70
4178877-17887797.816100.54
5183995-183995100.615103.33
6179775-17977598.308100.97
60min1169938-16993892.92896.502.6796.0799.712.63
2172977-17297794.59097.77
3176222-17622296.36599.57
4178128-17812897.407100.67
5183571-183571100.383103.65
6177957-17795797.313100.52
极限1176186-17618696.34596.311.35100.00100.061.33
2171626-17162693.85197.56
3176595-17659596.569100.31
4176281-17628196.397100.20
5178261-17826197.480101.31
6177835-17783597.247100.99
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%
111.121931681930391909171930311919031924120.51
211.071912941903121908030.37
单位质量响应值RSD%判断
17303.2417236.040.28数据可信
中间条件24月-供试品溶液-2023122121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%
5min1119368-11936862.05361.679.9962.0561.669.99
2126543-12654365.78365.78
3118970-11897061.84661.85
4120520-12052062.65262.65
596211-9621150.01550.01
6130121-13012167.64367.64
10min1172921-17292189.89289.334.3890.2489.674.40
2178140-17814092.60592.97
3174733-17473390.83491.18
4173389-17338990.13590.48
5156949-15694981.58981.87
6174914-17491490.92891.30
15min1182531-18253194.88895.802.3195.7396.642.34
2186635-18663597.02197.90
3186414-18641496.90697.75
4185282-18528296.31897.17
5176526-17652691.76692.50
6188276-18827697.87498.76
20min1184551-18455195.93896.851.0097.3198.221.03
2185840-18584096.60898.03
3187775-18777597.61499.00
4185717-18571796.54497.93
5184666-18466695.99897.24
6189268-18926898.39099.81
30min1182890-18289095.07497.221.9696.9899.131.92
2187676-18767697.56299.52
3184339-18433995.82897.76
4185049-18504996.19798.12
5189496-18949698.509100.28
6192669-192669100.158102.13
45min1181205-18120594.19896.642.0696.6399.092.04
2186919-18691997.16999.67
3186476-18647696.93999.40
4183064-18306495.16597.62
5185451-18545196.40698.73
6192321-19232199.977102.50
60min1177959-17795992.51194.651.8495.4797.641.78
2179990-17999093.56796.60
3180298-18029893.72796.73
4182206-18220694.71997.70
5185811-18581196.59399.45
6186218-18621896.80499.89
极限1182464-18246494.85394.551.2898.3298.061.30
2180079-18007993.61397.17
3181888-18188894.55498.07
4181576-18157694.39197.90
5179319-17931993.21896.61
6185971-18597196.676100.30
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%
111.251772541793351784531781191796241785570.54
211.331776951766811771880.41
单位质量响应值RSD%判断
15871.7315638.831.05数据可信
中间条件24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%
5min1131018-13101871.21080.999.8971.2180.999.89
2134928-13492873.33573.34
3142197-14219777.28677.29
4159227-15922786.54286.54
5164344-16434489.32389.32
6162306-16230688.21688.22
10min1177509-17750996.47996.222.1896.8796.672.20
2169583-16958392.17192.58
3177444-17744496.44396.87
4178686-17868697.11897.60
5180774-18077498.25398.75
6178244-17824496.87897.37
15min1183835-18383599.91798.301.40100.8599.281.40
2178009-17800996.75197.67
3180561-18056198.13899.10
4178259-17825996.88697.91
5183688-18368899.837100.88
6180786-18078698.26099.29
20min1189869-189869103.19798.572.43104.68100.102.37
2180971-18097198.36099.82
3177679-17767996.57198.08
4181524-18152498.661100.22
5179295-17929597.44999.05
6178790-17879097.17598.75
30min1181664-18166498.73798.061.09100.80100.141.05
2182686-18268699.293101.30
3177622-17762296.54098.59
4181470-18147098.632100.74
5180488-18048898.098100.24
6178546-17854697.04299.16
45min1180062-18006297.86698.021.16100.47100.651.16
2181031-18103198.393100.95
3176937-17693796.16898.75
4181424-18142498.607101.26
5183116-18311699.526102.21
6179543-17954397.584100.24
60min1175142-17514295.19295.640.8998.3498.800.83
2177133-17713396.27499.38
3177356-17735696.39699.51
4176215-17621595.77598.98
5173212-17321294.14397.38
6176713-17671396.04699.24
极限1175160-17516095.20295.130.1998.8898.830.14
2175397-17539795.33198.97
3175213-17521395.23198.88
4175112-17511295.17698.91
5174680-17468094.94198.70
6174601-17460194.89898.63
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%
111.121930751933781950411930481933641935810.43
211.071926251918501922380.29
单位质量响应值RSD%判断
17408.3617365.670.18数据可信
中间条件24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%
5min186329-8632944.57558.3220.7244.5758.3220.72
298659-9865950.94150.94
399713-9971351.48551.49
4112142-11214257.90357.90
5148781-14878176.82176.82
6132061-13206168.18868.19
10min1168188-16818886.84188.552.9687.0988.873.02
2167362-16736286.41586.70
3167518-16751886.49586.78
4170087-17008787.82288.14
5178058-17805891.93792.36
6177772-17777291.79092.17
15min1183602-18360294.80094.711.6295.5395.521.66
2181735-18173593.83694.60
3183912-18391294.96095.73
4178561-17856192.19793.01
5186288-18628896.18797.12
6186447-18644796.26997.16
20min1191523-19152398.89095.841.63100.1597.191.55
2185298-18529895.67696.96
3183707-18370794.85496.15
4185513-18551395.78797.11
5184238-18423895.12896.60
6183454-18345494.72496.15
30min1183262-18326294.62495.650.9896.4397.520.96
2187641-18764196.88598.70
3183857-18385794.93296.75
4187151-18715196.63298.49
5185334-18533495.69497.69
6184225-18422595.12297.07
45min1185328-18532895.69195.880.6598.0298.290.69
2185560-18556095.81198.17
3184082-18408295.04897.40
4186029-18602996.05398.44
5187743-18774396.93899.47
6185473-18547395.76698.24
60min1180138-18013893.01193.501.2295.8796.441.13
2182232-18223294.09396.98
3183668-18366894.83497.71
4181533-18153393.73296.66
5177248-17724891.51994.59
6181704-18170493.82096.83
极限1179401-17940192.63193.170.6696.0196.630.61
2180741-18074193.32396.73
3181152-18115293.53596.94
4182220-18222094.08697.53
5179018-17901892.43396.01
6180133-18013393.00996.54
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%
111.251748461760411761551764641764561759920.38
211.331760961749991755480.45
单位质量响应值RSD%判断
15643.7315494.090.68数据可信
中间条件24月-供试品溶液-2023122321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%
5min1140897-14089777.49474.764.0077.4974.764.00
2128782-12878270.83170.83
3140813-14081377.44877.45
4139432-13943276.68876.69
5129946-12994671.47171.47
6135723-13572374.64874.65
10min1175262-17526296.39595.573.1696.8395.983.16
2175998-17599896.80097.19
3174140-17414095.77896.21
4178535-17853598.19598.62
5162951-16295189.62490.02
6175651-17565196.60997.02
15min1180129-18012999.07298.482.35100.0499.422.35
2180991-18099199.546100.48
3177372-17737297.55598.52
4179419-17941998.68199.65
5171902-17190294.54795.44
6184482-184482101.466102.42
20min1181231-18123199.67899.502.56101.19100.992.55
2179108-17910898.51099.99
3181998-181998100.100101.60
4180964-18096499.531101.05
5173899-17389995.64597.07
6188198-188198103.510105.02
30min1178181-17818198.00097.962.49100.07100.012.48
2181152-18115299.634101.67
3177841-17784197.81399.87
4182949-182949100.623102.70
5170024-17002493.51495.47
6178552-17855298.204100.29
45min1179780-17978098.88098.041.18101.49100.631.20
2178072-17807297.940100.53
3178478-17847898.164100.77
4179660-17966098.814101.45
5174217-17421795.82098.29
6179282-17928298.606101.24
60min1178750-17875098.31397.942.10101.48101.072.07
2182302-182302100.267103.40
3174459-17445995.95399.10
4176743-17674397.209100.39
5173802-17380295.59298.60
6182319-182319100.276103.46
极限1175964-17596496.78197.531.04100.49101.211.06
2178716-17871698.294101.98
3176323-17632396.978100.66
4179555-17955598.756102.48
5174902-17490296.19799.73
6178467-17846798.158101.90
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%
111.121911041917241925821922051922351919700.30
211.071917571910171913870.28
单位质量响应值RSD%判断
17263.4917288.800.11数据可信
中间条件24月-供试品溶液-2023122321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%
5min1103161-10316153.60747.8914.9253.6147.8914.93
283818-8381843.55643.56
3108565-10856556.41656.42
475117-7511739.03439.03
5100955-10095552.46152.46
681315-8131542.25542.26
10min1176077-17607791.49884.764.9491.8085.034.96
2163391-16339184.90685.15
3166724-16672486.63886.95
4153124-15312479.57179.79
5162799-16279984.59884.89
6156572-15657281.36281.60
15min1184281-18428195.76193.251.8696.5793.991.90
2177119-17711992.03992.75
3179802-17980293.43494.23
4174541-17454190.70091.36
5180907-18090794.00894.77
6180066-18006693.57194.26
20min1185109-18510996.19195.861.6797.5397.111.67
2180995-18099594.05495.28
3187300-18730097.33098.64
4181871-18187194.50995.67
5182891-18289195.03996.32
6188646-18864698.02999.24
30min1182610-18261094.89395.281.2296.7797.061.15
2184578-18457895.91597.66
3183368-18336895.28797.14
4186978-18697897.16398.85
5180578-18057893.83795.65
6181968-18196894.55996.31
45min1183971-18397195.60095.831.0698.0098.151.05
2181260-18126094.19196.47
3187081-18708197.21699.60
4185670-18567096.48398.71
5184099-18409995.66798.00
6184443-18444395.84598.12
60min1182951-18295195.07095.421.1998.0098.271.13
2186025-18602596.66799.47
3180850-18085093.97896.90
4181936-18193694.54397.31
5183783-18378395.50298.37
6186253-18625396.78699.59
极限1180837-18083793.97195.261.2697.4398.641.20
2182688-18268894.93398.27
3183595-18359595.40598.85
4185928-18592896.61799.91
5185968-18596896.638100.03
6180868-18086893.98897.33
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