氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.793360073364313366363368063365503364860.09
214.843384893393063388980.18
单位质量响应值RSD%判断
22750.9122836.790.27数据可信
供试品溶液-H328批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1180393-18039345.92442.006.2345.9242.006.23
2161654-16165441.15341.15
3173520-17352044.17444.17
4155772-15577239.65639.66
5153988-15398839.20239.20
6164590-16459041.90141.90
10min1375755-37575595.65891.582.9995.7391.652.99
2360763-36076391.84291.91
3365151-36515192.95993.03
4351958-35195889.60089.67
5344560-34456087.71787.78
6360167-36016791.69091.76
15min1405663-405663103.272101.651.16103.51101.871.16
2399010-399010101.579101.80
3396779-396779101.011101.24
4392493-39249399.920100.13
5402874-402874102.562102.77
6398965-398965101.567101.79
20min1403489-403489102.719101.500.96103.13101.900.96
2399808-399808101.782102.17
3397028-397028101.074101.47
4393710-393710100.229100.61
5402286-402286102.413102.80
6396003-396003100.813101.21
30min1402866-402866102.560101.351.49103.14101.911.49
2405366-405366103.197103.76
3394817-394817100.511101.08
4389103-38910399.05799.61
5400199-400199101.881102.43
6396362-396362100.905101.46
45min1401359-401359102.177100.991.22102.93101.721.22
2400046-400046101.842102.57
3393646-393646100.213100.95
4388688-38868898.95199.66
5399736-399736101.763102.49
6396641-396641100.976101.70
极限1399665-399665101.745100.601.18102.67101.501.18
2396936-396936101.051101.95
3393052-393052100.062100.96
4387559-38755998.66399.54
5399764-399764101.771102.66
6393951-393951100.291101.19
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.793378343375093377003381763382493378940.10
214.843377603376633377120.03
单位质量响应值RSD%判断
22846.1122756.870.28数据可信
供试品溶液-H328批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179905-17990545.78441.796.4145.7841.796.41
2158378-15837840.30640.31
3172482-17248243.89543.90
4156991-15699139.95339.95
5151921-15192138.66338.66
6165587-16558742.14042.14
10min1363704-36370492.56091.211.8592.6491.281.86
2347103-34710388.33588.40
3360367-36036791.71091.78
4363270-36327092.44992.52
5353746-35374690.02590.09
6362241-36224192.18792.26
15min1398406-398406101.391101.880.53101.62102.100.53
2401460-401460102.168102.38
3400244-400244101.859102.08
4403986-403986102.811103.03
5399212-399212101.596101.81
6398654-398654101.454101.68
20min1394832-394832100.481101.680.92100.88102.080.91
2403330-403330102.644103.03
3398583-398583101.436101.83
4404489-404489102.939103.33
5398532-398532101.423101.81
6397551-397551101.173101.57
30min1396897-396897101.007101.490.65101.57102.050.65
2401474-401474102.172102.73
3398269-398269101.356101.92
4402441-402441102.418102.98
5397706-397706101.213101.77
6395964-395964100.769101.33
45min1396405-396405100.882101.430.88101.62102.160.88
2401385-401385102.149102.88
3395671-395671100.695101.43
4404390-404390102.914103.65
5396966-396966101.024101.75
6396584-396584100.927101.66
极限1395828-395828100.735101.130.88101.64102.030.88
2399276-399276101.612102.51
3393389-393389100.114101.02
4403360-403360102.652103.56
5396064-396064100.795101.68
6396283-396283100.851101.75
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