苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.591014621010321010681008761012291011330.22
219.481011731005061008400.47
单位质量响应值RSD%判断
5162.485176.590.20数据可信
供试品溶液-2025032621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%
5min199332-9933298.15198.971.6798.1598.971.67
2101020-10102099.81999.82
3101806-101806100.596100.60
4101234-101234100.031100.03
597231-9723196.07596.08
6100354-10035499.16199.16
10min1101091-10109199.889100.311.56100.05100.471.56
2102457-102457101.239101.41
3102966-102966101.742101.91
4102219-102219101.004101.17
598557-9855797.38597.55
6101788-101788100.578100.74
15min1101015-10101599.814100.101.57100.14100.431.57
2101757-101757100.547100.88
3102867-102867101.644101.98
4102171-102171100.956101.29
598311-9831197.14297.46
6101702-101702100.493100.83
20min1100647-10064799.45199.841.4999.95100.341.49
2101780-101780100.570101.07
3102194-102194100.979101.49
4102006-102006100.793101.30
598185-9818597.01897.50
6101410-101410100.204100.70
30min1100173-10017398.98299.741.6399.64100.411.63
2101918-101918100.706101.38
3102294-102294101.078101.75
4101954-101954100.742101.41
597957-9795796.79397.44
6101369-101369100.164100.83
45min1100382-10038299.18999.451.66100.02100.281.66
2101785-101785100.575101.41
3102253-102253101.037101.88
4100995-10099599.794100.63
597525-9752596.36697.17
6100911-10091199.711100.55
极限1100111-10011198.92199.281.6099.91100.281.60
2101336-101336100.131101.14
3102087-102087100.873101.89
4101374-101374100.169101.17
597537-9753796.37897.35
6100380-10038099.187100.19
苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.591007811008821009451008681007601008470.08
219.481007501002431004960.36
单位质量响应值RSD%判断
5147.885158.930.16数据可信
供试品溶液-2025032621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%
5min193051-9305192.23398.673.6592.2398.673.65
2102585-102585101.683101.68
3101361-101361100.469100.47
4102580-102580101.678101.68
598209-9820997.34597.35
699499-9949998.62498.62
10min199641-9964198.765101.191.9498.92101.351.94
2104560-104560103.640103.81
3101617-101617100.723100.89
4104332-104332103.414103.58
5101645-101645100.751100.91
6100723-10072399.837100.00
15min199815-9981598.937101.101.9399.26101.441.94
2104494-104494103.575103.92
3102180-102180101.281101.62
4104095-104095103.179103.52
5101270-101270100.379100.71
6100155-10015599.27499.60
20min199505-9950598.630101.011.7899.11101.511.78
2103830-103830102.917103.43
3102317-102317101.417101.92
4103982-103982103.067103.58
5101290-101290100.399100.90
6100510-10051099.626100.12
30min199512-9951298.637100.761.8199.28101.431.82
2103920-103920103.006103.69
3101709-101709100.814101.49
4103746-103746102.833103.52
5100892-100892100.005100.67
6100167-10016799.28699.95
45min199373-9937398.499100.431.8399.31101.271.83
2103630-103630102.719103.58
3101288-101288100.397101.24
4103344-103344102.435103.29
5100889-100889100.002100.83
699403-9940398.52999.36
极限199347-9934798.473100.151.7399.45101.151.74
2102896-102896101.991103.02
3100541-10054199.657100.67
4103501-103501102.591103.62
5100344-10034499.461100.46
699576-9957698.70099.69
苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.592012542024012025312003662004222013950.52
219.482020462019962020210.02
单位质量响应值RSD%判断
10280.5010370.690.62数据可信
供试品溶液-2025032621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%
5min1179571-17957188.83691.503.3588.8491.503.35
2176246-17624687.19187.19
3188387-18838793.19793.20
4186270-18627092.15092.15
5185819-18581991.92691.93
6193493-19349395.72395.72
10min1202394-202394100.126100.710.39100.27100.860.39
2204324-204324101.081101.23
3203711-203711100.778100.93
4203120-203120100.485100.64
5203393-203393100.620100.77
6204496-204496101.166101.33
15min1204188-204188101.014101.020.46101.33101.340.46
2205585-205585101.705102.02
3204723-204723101.278101.60
4203292-203292100.571100.89
5203042-203042100.447100.77
6204319-204319101.079101.41
20min1203658-203658100.752101.040.46101.23101.530.46
2205017-205017101.424101.91
3205588-205588101.706102.20
4203517-203517100.682101.17
5203210-203210100.530101.02
6204442-204442101.139101.64
30min1203189-203189100.520100.570.41101.17101.230.40
2204347-204347101.092101.74
3203751-203751100.798101.46
4203489-203489100.668101.32
5201902-20190299.883100.54
6203086-203086100.469101.13
45min1204064-204064100.952100.800.49101.77101.620.48
2205389-205389101.608102.43
3203107-203107100.479101.31
4203236-203236100.543101.37
5202638-202638100.247101.07
6204103-204103100.972101.80
极限1203323-203323100.586100.550.54101.57101.540.53
2204829-204829101.331102.32
3204272-204272101.055102.05
4202483-202483100.170101.16
5202211-202211100.036101.03
6202392-202392100.125101.13
苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.592021172014342015372022312020202018680.18
219.482018992018812018900.01
单位质量响应值RSD%判断
10304.6510363.960.41数据可信
供试品溶液-2025032621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%
5min1181995-18199589.95892.865.2789.9692.865.27
2204833-204833101.246101.25
3177640-17764087.80587.81
4182088-18208890.00490.00
5193216-19321695.50495.50
6187478-18747892.66892.67
10min1209143-209143103.377101.751.67103.53101.911.67
2209884-209884103.743103.91
3203362-203362100.519100.67
4207276-207276102.454102.60
5204090-204090100.879101.04
6201366-20136699.53399.69
15min1210307-210307103.952102.221.55104.27102.541.55
2209581-209581103.593103.93
3205846-205846101.747102.06
4207881-207881102.753103.07
5205690-205690101.670102.00
6201551-20155199.62499.94
20min1210294-210294103.946101.811.95104.44102.301.95
2209549-209549103.577104.09
3204068-204068100.868101.35
4207347-207347102.489102.98
5205189-205189101.422101.92
6199410-19941098.56699.05
30min1208680-208680103.148101.851.82103.82102.521.82
2209856-209856103.729104.42
3205226-205226101.441102.09
4208322-208322102.971103.63
5204574-204574101.118101.78
6199692-19969298.70599.36
45min1209191-209191103.400101.721.63104.24102.551.63
2208370-208370102.995103.85
3203614-203614100.644101.46
4208068-208068102.845103.68
5204922-204922101.290102.12
6200595-20059599.15299.97
极限1207553-207553102.591101.431.45103.60102.431.45
2208301-208301102.961103.99
3203700-203700100.686101.67
4206997-206997102.316103.32
5204151-204151100.909101.91
6200513-20051399.111100.09
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