氢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250
标示量(mg)40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%
114.636810646807246811746825286830066816990.15
214.626798996809616804300.12
单位质量响应值RSD%判断
46595.9746541.040.09数据可信
供试品溶液-J057批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1222815-22281527.76427.3312.7127.7627.3412.71
2189775-18977523.64723.65
3236689-23668929.49329.49
4180136-18013622.44622.45
5242020-24202030.15730.16
6244768-24476830.50030.50
10min1577359-57735971.94371.723.3171.9971.763.32
2548611-54861168.36168.40
3585135-58513572.91272.96
4556275-55627569.31669.35
5595593-59559374.21574.27
6590308-59030873.55773.61
15min1796258-79625899.21999.212.0599.3999.372.05
2786344-78634497.98498.14
3817070-817070101.813101.98
4771590-77159096.14696.30
5809883-809883100.917101.09
6795768-79576899.15899.33
20min1815254-815254101.586102.400.83101.92102.730.83
2820615-820615102.254102.57
3834141-834141103.940104.28
4824428-824428102.730103.04
5818156-818156101.948102.29
6818194-818194101.953102.29
30min1817387-817387101.852102.300.69102.35102.810.68
2819952-819952102.172102.66
3831041-831041103.554104.07
4823722-823722102.642103.13
5817797-817797101.903102.42
6816187-816187101.703102.21
45min1812481-812481101.241102.040.80101.91102.710.80
2817985-817985101.927102.58
3829644-829644103.379104.07
4823546-823546102.620103.28
5814937-814937101.547102.23
6814836-814836101.534102.21
极限1811400-811400101.106101.740.74101.95102.580.74
2815497-815497101.617102.44
3827537-827537103.117103.98
4818575-818575102.000102.83
5813359-813359101.350102.20
6812430-812430101.235102.08
氢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250
标示量(mg)40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%
114.636802396794846789756796656794046795530.07
214.626805176801376803270.04
单位质量响应值RSD%判断
46449.2846533.990.13数据可信
供试品溶液-J057批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1215225-21522526.86327.637.2026.8627.637.20
2215547-21554726.90326.90
3253217-25321731.60531.60
4217895-21789527.19627.20
5208907-20890726.07426.07
6217558-21755827.15427.15
10min1570364-57036471.18971.892.0171.2371.942.01
2568615-56861570.97171.02
3596742-59674274.48174.53
4572346-57234671.43671.48
5566001-56600170.64470.69
6581851-58185172.62372.67
15min1794099-79409999.11498.450.9799.2898.620.97
2787834-78783498.33298.50
3797556-79755699.54599.72
4791374-79137498.77498.94
5775733-77573396.82296.98
6786212-78621298.13098.30
20min1823701-823701102.809102.600.40103.14102.940.40
2825154-825154102.990103.32
3822160-822160102.616102.96
4824535-824535102.913103.24
5820448-820448102.403102.73
6816338-816338101.890102.22
30min1822900-822900102.709102.480.24103.21102.980.24
2819699-819699102.309102.81
3821663-821663102.554103.07
4823392-823392102.770103.27
5820364-820364102.392102.89
6818375-818375102.144102.64
45min1820524-820524102.412102.360.20103.08103.030.19
2818352-818352102.141102.81
3818362-818362102.142102.83
4821020-821020102.474103.15
5819888-819888102.333103.00
6822459-822459102.654103.32
极限1818559-818559102.167102.010.24103.01102.850.24
2817382-817382102.020102.86
3816872-816872101.956102.81
4819776-819776102.319103.16
5817211-817211101.999102.83
6813954-813954101.592102.43
氢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250
标示量(mg)40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%
114.636779886773606776946784446760666775100.14
214.626775876771296773580.05
单位质量响应值RSD%判断
46309.6446330.920.04数据可信
供试品溶液-J057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%
5min1273800-27380034.30032.749.3934.3032.749.38
2266751-26675133.41733.42
3293309-29330936.74436.74
4219589-21958927.50927.51
5253834-25383431.79931.80
6260907-26090732.68532.69
10min1627213-62721378.57476.794.4478.6376.844.44
2626328-62632878.46378.52
3636019-63601979.67779.74
4560644-56064470.23570.28
5609189-60918976.31676.37
6618238-61823877.45077.50
15min1820131-820131102.742101.522.85102.93101.702.85
2826229-826229103.506103.69
3822995-822995103.101103.29
4764389-76438995.75995.92
5815007-815007102.100102.28
6813431-813431101.902102.09
20min1822012-822012102.977102.950.84103.34103.300.84
2833616-833616104.431104.79
3822071-822071102.985103.35
4816838-816838102.329102.65
5822638-822638103.056103.41
6813507-813507101.912102.27
30min1822827-822827103.079102.870.73103.61103.390.74
2830493-830493104.040104.57
3821028-821028102.854103.39
4814120-814120101.989102.48
5823029-823029103.105103.63
6815243-815243102.129102.65
45min1820602-820602102.801102.730.68103.50103.420.68
2829971-829971103.974104.68
3819164-819164102.621103.33
4815861-815861102.207102.87
5820358-820358102.770103.46
6814068-814068101.982102.68
极限1818525-818525102.541102.450.77103.41103.320.77
2828509-828509103.791104.67
3816818-816818102.327103.21
4812186-812186101.746102.58
5819837-819837102.705103.57
6811160-811160101.618102.48
氢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250
标示量(mg)40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%
114.636753376761286764156771036760356762040.10
214.626758076777256767660.21
单位质量响应值RSD%判断
46220.3746290.420.11数据可信
供试品溶液-J057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%
5min1271043-27104334.00231.724.3334.0031.724.33
2250439-25043931.41831.42
3238654-23865429.93929.94
4255737-25573732.08232.08
5246016-24601630.86330.86
6254965-25496531.98631.99
10min1626431-62643178.58675.902.1278.6475.962.12
2603006-60300675.64775.70
3594018-59401874.52074.57
4592955-59295574.38774.44
5600507-60050775.33475.39
6613414-61341476.95377.01
15min1814898-814898102.229101.011.04102.42101.191.05
2802852-802852100.718100.90
3801564-801564100.557100.73
4800891-800891100.472100.65
5794999-79499999.73399.91
6815913-815913102.357102.54
20min1818172-818172102.640102.550.49103.00102.900.49
2822376-822376103.168103.51
3815699-815699102.330102.67
4813539-813539102.059102.40
5813280-813280102.026102.37
6821619-821619103.073103.42
30min1815566-815566102.313102.160.38102.84102.680.38
2818312-818312102.658103.18
3812280-812280101.901102.41
4812825-812825101.969102.48
5810364-810364101.661102.17
6816759-816759102.463102.99
45min1813208-813208102.017101.930.60102.72102.620.60
2820050-820050102.876103.57
3810049-810049101.621102.30
4806928-806928101.230101.91
5809065-809065101.498102.18
6815726-815726102.333103.03
极限1811205-811205101.766101.940.78102.64102.800.77
2822146-822146103.139104.00
3810662-810662101.698102.55
4806013-806013101.115101.97
5807512-807512101.303102.15
6818120-818120102.634103.50
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