普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.871058211057341058411061841059431059050.17
216.891052031044081048060.54
单位质量响应值RSD%判断
6277.716205.210.83数据可信
供试品溶液-2024120821批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min195741-9574191.48889.891.9491.4989.891.94
296643-9664392.35092.35
392140-9214088.04788.05
492973-9297388.84388.84
594309-9430990.12090.12
692599-9259988.48688.49
5min1108022-108022103.223102.051.01103.22102.051.01
2107646-107646102.864102.86
3106362-106362101.637101.64
4105128-105128100.458100.46
5107316-107316102.549102.55
6106277-106277101.556101.56
10min1107478-107478102.704102.381.06102.70102.381.06
2108302-108302103.491103.49
3105925-105925101.220101.22
4106439-106439101.711101.71
5108546-108546103.724103.72
6106123-106123101.409101.41
15min1107803-107803103.014102.601.23103.01102.601.23
2109017-109017104.174104.17
3105889-105889101.185101.19
4106537-106537101.804101.80
5108670-108670103.843103.84
6106301-106301101.579101.58
30min1107615-107615102.834102.630.94102.83102.630.94
2108710-108710103.881103.88
3106400-106400101.673101.67
4106774-106774102.031102.03
5108424-108424103.608103.61
6106506-106506101.775101.77
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.871053511045291050331048091056251050690.42
216.891052741057781055260.34
单位质量响应值RSD%判断
6228.166247.840.23数据可信
供试品溶液-2024120821批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min195413-9541391.22285.996.3691.2285.996.36
282013-8201378.41178.41
392793-9279388.71788.72
485227-8522781.48481.48
588174-8817484.30184.30
696027-9602791.80991.81
5min1106304-106304101.635100.260.86101.63100.260.86
2104889-104889100.282100.28
3104806-104806100.203100.20
4103541-10354198.99398.99
5104538-10453899.94799.95
6105099-105099100.483100.48
10min1104201-10420199.62499.570.4999.6299.560.49
2104555-10455599.96399.96
3104704-104704100.105100.11
4103892-10389299.32999.33
5104190-10419099.61499.61
6103301-10330198.76498.76
15min1106643-106643101.95999.591.19101.9699.591.19
2103451-10345198.90798.91
3103918-10391899.35499.35
4103384-10338498.84398.84
5103771-10377199.21399.21
6103817-10381799.25799.26
30min1106885-106885102.19099.581.43102.1999.581.43
2103722-10372299.16699.17
3103725-10372599.16999.17
4103368-10336898.82898.83
5104613-104613100.018100.02
6102641-10264198.13398.13
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.871058451050931052161052391055421053870.29
216.891049681047591048640.15
单位质量响应值RSD%判断
6247.016208.640.44数据可信
供试品溶液-2024120921批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min190026-9002686.21387.086.7286.2187.086.72
279354-7935475.99375.99
395151-9515191.12191.12
495066-9506691.04091.04
594987-9498790.96490.96
691003-9100387.14987.15
5min1104887-104887100.44599.630.95100.4499.630.95
2104065-10406599.65899.66
3105147-105147100.694100.69
4103268-10326898.89498.89
5104307-10430799.88999.89
6102543-10254398.20098.20
10min1104722-104722100.287100.320.79100.29100.320.79
2103477-10347799.09499.09
3105855-105855101.372101.37
4105413-105413100.948100.95
5104619-104619100.188100.19
6104435-104435100.012100.01
15min1104513-104513100.087100.800.50100.09100.800.50
2104985-104985100.539100.54
3106019-106019101.529101.53
4105392-105392100.928100.93
5105091-105091100.640100.64
6105562-105562101.091101.09
30min1106999-106999102.467101.040.78102.47101.040.78
2104589-104589100.159100.16
3104980-104980100.534100.53
4105472-105472101.005101.00
5105511-105511101.042101.04
6105510-105510101.041101.04
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.871041781036581033791035351023391034180.66
216.891052311058361055340.41
单位质量响应值RSD%判断
6130.296248.311.35数据可信
供试品溶液-2024120921批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min193207-9320789.82289.531.1889.8289.531.18
294666-9466691.22891.23
393396-9339690.00490.00
491791-9179188.45888.46
592501-9250189.14289.14
691869-9186988.53388.53
5min1105699-105699101.861102.690.88101.86102.690.88
2107111-107111103.221103.22
3106015-106015102.165102.17
4106140-106140102.286102.29
5108204-108204104.275104.27
6106173-106173102.317102.32
10min1105542-105542101.709103.020.92101.71103.020.92
2107612-107612103.704103.70
3106486-106486102.619102.62
4106432-106432102.567102.57
5108311-108311104.378104.38
6107016-107016103.130103.13
15min1105815-105815101.972102.930.80101.97102.930.80
2108143-108143104.216104.22
3106487-106487102.620102.62
4106225-106225102.368102.37
5107403-107403103.503103.50
6106788-106788102.910102.91
30min1105156-105156101.337102.590.74101.34102.590.74
2107218-107218103.324103.32
3106257-106257102.398102.40
4106178-106178102.322102.32
5107222-107222103.328103.33
6106723-106723102.847102.85
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