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)0
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%
110.761652261654921658131660811665431658310.31
210.801676781683141679960.27
单位质量响应值RSD%判断
15411.8015555.190.66数据可信
供试品溶液-25110501批-瑞舒伐他汀钙-pH2.0(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%
5min1117847-11784765.17467.067.2665.1767.057.26
2118115-11811565.32265.32
3129294-12929471.50471.50
4106620-10662058.96558.96
5128142-12814270.86770.87
6127482-12748270.50270.50
10min1160072-16007288.52689.342.6388.8989.712.63
2156495-15649586.54886.91
3165063-16506391.28691.68
4160023-16002388.49988.83
5168128-16812892.98193.37
6159502-15950288.21188.60
15min1171371-17137194.77594.322.5795.6395.192.58
2164228-16422890.82491.67
3174923-17492396.73997.64
4167598-16759892.68893.51
5175667-17566797.15098.06
6169501-16950193.74094.62
20min1179969-17996999.53096.662.58100.9198.062.57
2168671-16867193.28194.63
3178013-17801398.44899.89
4172856-17285695.59696.93
5177960-17796098.41899.87
6171258-17125894.71296.11
30min1176886-17688697.82596.022.6499.7697.962.63
2166771-16677192.23194.10
3178255-17825598.582100.57
4172650-17265095.48297.35
5177104-17710497.94599.94
6170124-17012494.08596.01
45min1173318-17331895.85195.032.1098.3397.492.11
2166354-16635492.00094.38
3176105-17610597.39399.93
4170860-17086094.49296.89
5174753-17475396.64599.19
6169588-16958893.78896.24
60min1172412-17241295.35094.022.0298.3697.012.03
2165373-16537391.45794.35
3173412-17341295.90398.98
4167918-16791892.86595.79
5173186-17318695.77898.86
6167708-16770892.74995.72
极限1171384-17138494.78293.552.3198.3297.062.32
2164077-16407790.74194.14
3173623-17362396.02099.63
4167105-16710592.41595.85
5172620-17262095.46599.08
6166097-16609791.85895.35
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)0
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%
111.681996361999771992852006362003671999800.28
211.722031492016072023780.54
单位质量响应值RSD%判断
17121.5817267.750.61数据可信
供试品溶液-25110501批-依折麦布-pH2.0(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%
5min185044-8504444.40352.5129.2244.4052.5129.22
288727-8872746.32646.33
3109312-10931257.07457.07
456835-5683529.67529.67
5132433-13243369.14669.15
6131062-13106268.43068.43
10min1161608-16160884.37988.435.5384.6388.725.60
2159735-15973583.40183.66
3174834-17483491.28491.60
4161573-16157384.36084.53
5179731-17973193.84194.23
6178693-17869393.29993.68
15min1182758-18275895.42195.932.0796.1496.712.15
2178174-17817493.02893.75
3186579-18657997.41698.24
4180995-18099594.50195.13
5185459-18545996.83297.74
6188400-18840098.36799.27
20min1193863-193863101.22098.731.60102.47100.051.57
2185558-18555896.88398.12
3190363-19036399.392100.76
4188917-18891798.63799.80
5186223-18622397.23198.67
6189648-18964899.019100.46
30min1192737-192737100.63299.741.43102.44101.611.36
2187948-18794898.13199.91
3193479-193479101.019102.94
4193870-193870101.223102.93
5187866-18786698.088100.07
6190334-19033499.377101.37
45min1189231-18923198.80199.581.62101.17102.001.56
2189776-18977699.086101.41
3194019-194019101.301103.78
4193975-193975101.278103.55
5185966-18596697.09699.62
6191401-19140199.934102.48
60min1190260-19026099.33899.301.10102.25102.271.02
2189985-18998599.195102.07
3192925-192925100.730103.77
4192104-192104100.301103.13
5187652-18765297.977101.04
6188189-18818998.257101.36
极限1190987-19098799.71899.421.29103.19102.951.23
2188420-18842098.378101.80
3193427-193427100.992104.59
4192640-192640100.581103.97
5187029-18702997.651101.26
6190042-19004299.225102.87
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)0
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%
110.761637091630071641081631991643081636660.35
210.801654381656911655640.11
单位质量响应值RSD%判断
15210.5915330.000.56数据可信
供试品溶液-25110502批-瑞舒伐他汀钙-pH2.0(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%
5min198013-9801354.96162.567.7354.9662.567.73
2115057-11505764.51964.52
3120181-12018167.39267.39
4105865-10586559.36459.36
5110530-11053061.98061.98
6119768-11976867.16067.16
10min1150030-15003084.13085.433.1084.4485.783.11
2151127-15112784.74585.10
3160206-16020689.83690.21
4148136-14813683.06883.40
5148770-14877083.42383.77
6155848-15584887.39387.77
15min1161949-16194990.81490.891.3291.5991.711.33
2159302-15930289.32990.16
3164936-16493692.48993.36
4162180-16218090.94391.73
5160220-16022089.84490.65
6163933-16393391.92692.78
20min1169180-16918094.86994.282.4296.1595.612.42
2165484-16548492.79694.12
3171990-17199096.44497.83
4165824-16582492.98794.28
5162938-16293891.36892.68
6173369-17336997.21898.59
30min1169601-16960195.10593.761.9096.9195.611.89
2162379-16237991.05592.90
3167965-16796594.18796.11
4166822-16682293.54695.36
5165169-16516992.61994.43
6171266-17126696.03897.95
45min1169535-16953595.06893.762.4297.4096.132.41
2162936-16293691.36793.71
3169657-16965795.13697.58
4164530-16453092.26194.59
5163676-16367691.78294.11
6172903-17290396.95699.40
60min1165639-16563992.88392.121.2395.7495.021.24
2162612-16261291.18594.04
3164787-16478792.40595.38
4163786-16378691.84494.69
5161704-16170490.67693.52
6167195-16719593.75596.74
极限1165963-16596393.06591.291.9396.4494.691.91
2159606-15960689.50092.86
3162443-16244391.09194.58
4162365-16236591.04794.40
5159425-15942589.39892.74
6166967-16696793.62897.13
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)0
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%
111.681992751986731980061981351988781985930.27
211.722020762032442026600.41
单位质量响应值RSD%判断
17002.8317291.811.20数据可信
供试品溶液-25110502批-依折麦布-pH2.0(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%
5min157629-5762930.17441.9528.6130.1741.9528.61
2113568-11356859.46359.46
395448-9544849.97549.98
457097-5709729.89529.90
567734-6773435.46535.46
689213-8921346.71146.71
10min1151874-15187479.51983.288.3279.6983.528.37
2178031-17803193.21593.55
3166345-16634587.09687.37
4139654-13965473.12173.29
5155187-15518781.25481.45
6163256-16325685.47985.74
15min1177525-17752592.95093.552.1593.5694.252.24
2185589-18558997.17298.02
3178350-17835093.38294.14
4173843-17384391.02291.59
5177720-17772093.05293.70
6179021-17902193.73394.47
20min1187770-18777098.31497.551.5099.4498.761.57
2189246-18924699.087100.48
3187498-18749898.17299.45
4182864-18286495.74596.82
5182717-18271795.66996.83
6187723-18772398.29099.54
30min1187142-18714297.98598.210.7599.6699.970.80
2190021-19002199.493101.43
3185884-18588497.32799.15
4187307-18730798.07299.68
5188170-18817098.524100.22
6186937-18693797.87899.68
45min1189371-18937199.15298.701.05101.37101.001.07
2187630-18763098.241100.73
3189581-18958199.262101.63
4186247-18624797.51799.67
5186743-18674397.776100.02
6191413-191413100.222102.57
60min1186812-18681297.81398.160.73100.58101.010.79
2190133-19013399.551102.59
3186266-18626697.527100.44
4187147-18714797.988100.68
5187447-18744798.145100.93
6187051-18705197.938100.84
极限1187743-18774398.30097.210.92101.61100.610.90
2187512-18751298.179101.77
3183474-18347496.06599.52
4185778-18577897.271100.51
5185188-18518896.962100.29
6184323-18432396.50999.96
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)0
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%
110.761632161632651634821641561625991633440.35
210.801652801655111653960.10
单位质量响应值RSD%判断
15180.6715314.440.63数据可信
供试品溶液-25110503批-瑞舒伐他汀钙-pH2.0(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%
5min1111327-11132762.52164.902.9262.5264.902.91
2116568-11656865.46465.46
3115797-11579765.03165.03
4115337-11533764.77264.77
5113159-11315963.54963.55
6121195-12119568.06268.06
10min1151274-15127484.95486.011.1285.3086.371.13
2154641-15464186.84587.21
3153804-15380486.37586.74
4152786-15278685.80486.16
5151194-15119484.91085.26
6155251-15525187.18887.57
15min1159305-15930589.46592.872.2390.2893.712.22
2164496-16449692.38093.23
3165305-16530592.83493.68
4170708-17070895.86896.71
5165652-16565293.02993.85
6166718-16671893.62894.49
20min1162137-16213791.05594.972.3192.3796.322.30
2168100-16810094.40495.76
3168761-16876194.77596.13
4171025-17102596.04797.42
5171369-17136996.24097.58
6173268-17326897.30698.69
30min1161120-16112090.48494.862.7392.3196.742.70
2169514-16951495.19897.08
3167490-16749094.06195.94
4169903-16990395.41697.32
5175216-17521698.400100.28
6170257-17025795.61597.54
45min1161727-16172790.82595.082.3493.1597.492.33
2170662-17066295.84398.26
3169271-16927195.06197.47
4169567-16956795.22897.66
5171591-17159196.36498.79
6172977-17297797.14399.60
60min1155220-15522087.17193.743.5290.0096.683.47
2167340-16734093.97796.92
3168337-16833794.53797.47
4169416-16941695.14398.10
5170693-17069395.86098.82
6170488-17048895.74598.74
极限1160588-16058890.18593.561.9393.5097.021.93
2167532-16753294.08597.55
3166293-16629393.38996.85
4166690-16669093.61297.10
5169392-16939295.12998.62
6169138-16913894.98798.51
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)0
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%
111.681994872001681993701979351992801992480.41
211.722001722001792001760.01
单位质量响应值RSD%判断
17058.9017079.860.09数据可信
供试品溶液-25110503批-依折麦布-pH2.0(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%
5min189356-8935646.99645.1314.2747.0045.1314.28
297266-9726651.15651.16
399306-9930652.22952.23
477882-7788240.96140.96
566889-6688935.18035.18
684157-8415744.26244.26
10min1169952-16995289.38586.974.9189.6587.234.94
2171247-17124790.06690.35
3176323-17632392.73693.03
4158132-15813283.16883.40
5157627-15762782.90383.10
6158921-15892183.58383.83
15min1181493-18149395.45596.822.2796.2197.562.26
2181364-18136495.38796.17
3189254-18925499.537100.34
4189599-18959999.718100.41
5182356-18235695.90996.56
6180491-18049194.92895.64
20min1182331-18233195.89699.382.1597.18100.662.13
2186220-18622097.94199.26
3193525-193525101.783103.14
4191390-191390100.660101.90
5189372-18937299.599100.79
6190937-190937100.422101.66
30min1181672-18167295.54999.342.2497.37101.162.17
2188213-18821398.989100.85
3188223-18822398.994100.92
4191160-191160100.539102.34
5194390-194390102.238103.98
6189639-18963999.739101.53
45min1183551-18355196.537100.262.1298.89102.642.09
2191741-191741100.845103.25
3192287-192287101.132103.61
4192683-192683101.340103.70
5188576-18857699.180101.49
6194973-194973102.544104.89
60min1178218-17821893.73299.733.1896.62102.663.11
2188467-18846799.123102.09
3192869-192869101.438104.47
4194651-194651102.375105.30
5190233-190233100.051102.91
6193334-193334101.682104.60
极限1185194-18519497.40199.841.53100.81103.331.52
2188154-18815498.958102.48
3191327-191327100.627104.23
4193251-193251101.639105.13
5189403-18940399.615103.03
6191709-191709100.828104.31
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