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%
116.871046221048101041101034571034041040810.63
216.891049751045581047660.29
单位质量响应值RSD%判断
6169.596202.840.39数据可信
供试品溶液-2024120821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min193648-9364890.28589.980.8190.2889.980.82
292324-9232489.00889.01
393059-9305989.71789.72
492890-9289089.55489.55
594530-9453091.13591.14
693521-9352190.16290.16
5min1107104-107104103.257102.370.51103.26102.380.51
2105971-105971102.165102.17
3106275-106275102.458102.46
4106299-106299102.481102.48
5105977-105977102.171102.17
6105503-105503101.714101.71
10min1105964-105964102.158102.410.26102.16102.420.26
2105869-105869102.067102.07
3106358-106358102.538102.54
4106346-106346102.527102.53
5106233-106233102.418102.42
6106610-106610102.781102.78
15min1106109-106109102.298102.410.30102.30102.410.30
2106393-106393102.572102.57
3106037-106037102.229102.23
4106326-106326102.507102.51
5105800-105800102.000102.00
6106701-106701102.869102.87
30min1106689-106689102.857101.600.64102.86101.600.64
2105339-105339101.556101.56
3104804-104804101.040101.04
4105314-105314101.532101.53
5104985-104985101.215101.21
6105162-105162101.385101.39
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%
116.871057951057791048491047771047711051940.52
216.891054971044871049920.69
单位质量响应值RSD%判断
6235.576216.220.22数据可信
供试品溶液-2024120821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min194268-9426890.30388.123.0890.3088.123.08
290286-9028686.48886.49
390712-9071286.89686.90
488146-8814684.43884.44
595870-9587091.83791.84
692660-9266088.76288.76
5min1107889-107889103.351101.610.96103.35101.600.96
2105209-105209100.784100.78
3106372-106372101.898101.90
4105085-105085100.665100.66
5105842-105842101.390101.39
6106007-106007101.548101.55
10min1106513-106513102.033101.400.90102.03101.400.90
2104359-10435999.96999.97
3106360-106360101.886101.89
4106215-106215101.747101.75
5106670-106670102.183102.18
6104976-104976100.560100.56
15min1106478-106478101.999101.260.44102.00101.260.44
2105549-105549101.109101.11
3105305-105305100.876100.88
4105280-105280100.852100.85
5106025-106025101.565101.57
6105603-105603101.161101.16
30min1107085-107085102.581100.980.97102.58100.980.97
2104660-104660100.258100.26
3105932-105932101.476101.48
4105486-105486101.049101.05
5105125-105125100.703100.70
6104210-10421099.82799.83
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%
116.871051801051351048291047241036951047130.58
216.891054351046641050500.52
单位质量响应值RSD%判断
6207.056219.660.15数据可信
供试品溶液-2024120921批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min198003-9800394.07090.692.5894.0790.692.58
291832-9183288.14788.15
395843-9584391.99792.00
494529-9452990.73590.74
595005-9500591.19291.19
691662-9166287.98387.98
5min1104479-104479100.286101.430.83100.29101.440.83
2106287-106287102.022102.02
3105158-105158100.938100.94
4106952-106952102.660102.66
5105419-105419101.188101.19
6105753-105753101.509101.51
10min1105093-105093100.875101.681.12100.88101.681.12
2105805-105805101.559101.56
3104966-104966100.754100.75
4106649-106649102.369102.37
5105122-105122100.903100.90
6107979-107979103.646103.65
15min1105397-105397101.167101.821.18101.17101.821.18
2106051-106051101.795101.80
3105071-105071100.854100.85
4107902-107902103.572103.57
5104816-104816100.610100.61
6107223-107223102.920102.92
30min1104494-104494100.301101.560.95100.30101.560.95
2105896-105896101.646101.65
3105639-105639101.400101.40
4106787-106787102.502102.50
5104965-104965100.753100.75
6107055-107055102.759102.76
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%
116.871067011058211052591053571057721057820.54
216.891054561050831052700.26
单位质量响应值RSD%判断
6270.426232.680.43数据可信
供试品溶液-2024120921批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min195361-9536190.97690.740.9890.9890.740.98
293690-9369089.38189.38
394985-9498590.61790.62
494811-9481190.45190.45
596550-9655092.11092.11
695266-9526690.88590.88
5min1105108-105108100.274101.380.82100.27101.380.82
2106012-106012101.137101.14
3105515-105515100.663100.66
4106807-106807101.895101.90
5107355-107355102.418102.42
6106831-106831101.918101.92
10min1105680-105680100.820102.030.85100.82102.030.85
2106876-106876101.961101.96
3106079-106079101.201101.20
4107837-107837102.878102.88
5107560-107560102.614102.61
6107684-107684102.732102.73
15min1105773-105773100.909101.790.78100.91101.790.78
2106903-106903101.987101.99
3105689-105689100.829100.83
4107799-107799102.842102.84
5106840-106840101.927101.93
6107190-107190102.261102.26
30min1105591-105591100.735101.400.47100.74101.400.47
2106459-106459101.563101.56
3105923-105923101.052101.05
4106132-106132101.251101.25
5106755-106755101.846101.85
6106860-106860101.946101.95
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%
116.871053561056361054181053451054311054370.12
216.891061531061471061500.01
单位质量响应值RSD%判断
6249.976284.780.40数据可信
供试品溶液-22024121021批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min196331-9633191.66990.451.5291.6790.451.52
293809-9380989.26989.27
394590-9459090.01290.01
493882-9388289.33889.34
597324-9732492.61492.61
694352-9435289.78689.79
5min1105069-10506999.984100.581.2799.98100.581.27
2107236-107236102.046102.05
3104158-10415899.11799.12
4107174-107174101.987101.99
5106051-106051100.918100.92
6104484-10448499.42799.43
10min1104876-10487699.800101.161.7399.80101.161.73
2108705-108705103.444103.44
3105576-105576100.466100.47
4108592-108592103.336103.34
5105241-105241100.148100.15
6104820-10482099.74799.75
15min1105164-105164100.074100.531.44100.07100.541.43
2107694-107694102.482102.48
3104178-10417899.13699.14
4107396-107396102.198102.20
5104941-10494199.86299.86
6104515-10451599.45799.46
30min1104755-10475599.685100.371.4599.69100.371.45
2107364-107364102.168102.17
3104381-10438199.32999.33
4107469-107469102.268102.27
5104689-10468999.62299.62
6104185-10418599.14399.14
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%
116.871049891054391051141063751062571056350.62
216.891059171059151059160.01
单位质量响应值RSD%判断
6261.716270.930.11数据可信
供试品溶液-22024121021批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min193823-9382389.29790.571.9089.3090.571.90
298767-9876794.00294.00
394401-9440189.84789.85
494626-9462690.06190.06
594895-9489590.31790.32
694457-9445789.90089.90
5min1104483-10448399.442101.071.8599.44101.071.85
2106811-106811101.658101.66
3109279-109279104.007104.01
4107351-107351102.172102.17
5104497-10449799.45699.46
6104711-10471199.65999.66
10min1103153-10315398.176101.392.2398.18101.402.23
2106824-106824101.670101.67
3109869-109869104.568104.57
4108175-108175102.956102.96
5106252-106252101.126101.13
6104932-10493299.87099.87
15min1103524-10352498.530101.091.8898.53101.091.88
2107166-107166101.996102.00
3109251-109251103.980103.98
4106876-106876101.720101.72
5105506-105506100.416100.42
6104978-10497899.91399.91
30min1103127-10312798.152100.751.9898.15100.751.99
2106303-106303101.174101.17
3108671-108671103.428103.43
4107678-107678102.483102.48
5105081-105081100.011100.01
6104283-10428399.25299.25
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