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%
114.626726286734926740576745386745916738610.13
214.636735676726156730910.11
单位质量响应值RSD%判断
46091.7246007.590.13数据可信
供试品溶液-J057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%
5min1245383-24538330.92129.815.8730.9229.815.87
2227321-22732128.64528.64
3248199-24819931.27631.28
4240234-24023430.27230.27
5245436-24543630.92830.93
6212641-21264126.79526.80
10min1597333-59733375.27173.363.6075.3273.413.60
2573898-57389872.31872.37
3598385-59838575.40375.46
4551816-55181669.53569.59
5604286-60428676.14776.20
6567278-56727871.48371.53
15min1800963-800963100.93098.571.64101.1198.741.65
2773740-77374097.50097.67
3786625-78662599.12399.30
4766967-76696796.64696.81
5791006-79100699.67699.85
6773988-77398897.53197.69
20min1802488-802488101.122100.440.53101.47100.780.54
2795488-795488100.240100.57
3799848-799848100.790101.13
4799699-799699100.771101.10
5793020-79302099.929100.27
6791982-79198299.799100.12
30min1804644-804644101.394100.350.53101.91100.850.54
2794872-794872100.163100.66
3794586-794586100.127100.64
4794841-794841100.159100.65
5796022-796022100.308100.82
6793033-79303399.931100.42
45min1803261-803261101.220100.170.68101.90100.840.68
2792054-79205499.808100.47
3794344-794344100.096100.77
4799686-799686100.769101.43
5789994-78999499.548100.23
6790386-79038699.597100.26
极限1801922-801922101.051101.082.26101.90101.922.24
2792462-79246299.859100.69
3791713-79171399.765100.61
4801384-801384100.983101.81
5788097-78809799.309100.15
6837322-837322105.512106.34
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%
114.626711756713176710856702486713236710300.07
214.636729656732676731160.04
单位质量响应值RSD%判断
45898.0846009.300.18数据可信
供试品溶液-J057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%
5min1255408-25540832.25130.498.3032.2530.498.30
2222159-22215928.05328.05
3267734-26773433.80833.81
4225784-22578428.51128.51
5223136-22313628.17628.18
6254369-25436932.12032.12
10min1598024-59802475.51574.401.8975.5774.451.89
2583840-58384073.72473.77
3607437-60743776.70476.76
4582279-58227973.52773.57
5578788-57878873.08673.13
6584615-58461573.82273.88
15min1792355-792355100.05499.171.07100.2399.341.07
2780466-78046698.55398.72
3798323-798323100.808100.99
4783460-78346098.93199.10
5781620-78162098.69998.87
6775937-77593797.98198.16
20min1795910-795910100.503100.350.71100.85100.690.71
2793404-793404100.187100.52
3797694-797694100.728101.08
4797412-797412100.693101.03
5799680-799680100.979101.31
6784054-78405499.00699.35
30min1793413-793413100.188100.310.48100.70100.820.48
2794502-794502100.325100.83
3798636-798636100.847101.37
4797774-797774100.738101.24
5794096-794096100.274100.78
6787929-78792999.495100.00
45min1792675-792675100.094100.190.69100.78100.870.69
2796116-796116100.529101.20
3793146-793146100.154100.84
4795358-795358100.433101.10
5799816-799816100.996101.66
6783616-78361698.95199.62
极限1790954-79095499.87799.890.68100.72100.730.67
2788900-78890099.618100.45
3791362-79136299.929100.78
4795809-795809100.490101.33
5797118-797118100.656101.49
6782231-78223198.77699.61
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%
114.626749976751806743016745686743586746810.06
214.636737456740376738910.04
单位质量响应值RSD%判断
46147.8146062.270.14数据可信
供试品溶液-J057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%
5min1228112-22811228.71033.438.1828.7133.438.18
2280618-28061835.31935.32
3259230-25923032.62732.63
4267606-26760633.68133.68
5266287-26628733.51533.51
6291736-29173636.71836.72
10min1579232-57923272.90276.842.8672.9576.902.86
2625892-62589278.77578.83
3617213-61721377.68277.74
4602088-60208875.77975.83
5615578-61557877.47677.53
6623191-62319178.43578.50
15min1797022-797022100.313101.791.01100.48101.971.01
2812566-812566102.269102.46
3816880-816880102.812103.00
4801578-801578100.886101.07
5807995-807995101.694101.88
6816433-816433102.756102.95
20min1811381-811381102.120102.590.46102.46102.950.47
2814997-814997102.575102.94
3820278-820278103.240103.60
4816951-816951102.821103.17
5810365-810365101.992102.35
6816898-816898102.815103.18
30min1813779-813779102.422102.660.37102.93103.180.37
2814997-814997102.575103.11
3819251-819251103.111103.64
4817670-817670102.912103.43
5811083-811083102.083102.61
6817209-817209102.854103.39
45min1810897-810897102.059102.270.46102.74102.960.46
2812265-812265102.231102.93
3817700-817700102.915103.61
4813888-813888102.436103.13
5806547-806547101.512102.21
6813955-813955102.444103.15
极限1806987-806987101.567101.890.38102.41102.760.38
2811156-811156102.092102.96
3810133-810133101.963102.83
4810042-810042101.952102.82
5805329-805329101.358102.22
6813770-813770102.421103.30
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%
114.626737216739666735936741386733656737570.05
214.636742876734276738570.10
单位质量响应值RSD%判断
46084.6146059.950.04数据可信
供试品溶液-J057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%
5min1252910-25291031.85433.195.7131.8533.195.71
2278437-27843735.06935.07
3282395-28239535.56735.57
4262408-26240833.05033.05
5262376-26237633.04633.05
6242668-24266830.56430.56
10min1598387-59838775.36676.421.4875.4276.481.48
2614727-61472777.42477.48
3619265-61926577.99678.06
4608354-60835476.62276.68
5602538-60253875.88975.94
6597290-59729075.22875.28
15min1808984-808984101.891102.390.65102.07102.570.65
2815143-815143102.667102.85
3813328-813328102.438102.63
4816061-816061102.782102.96
5819270-819270103.186103.37
6804738-804738101.356101.53
20min1809253-809253101.925102.680.60102.27103.040.61
2816493-816493102.837103.20
3814802-814802102.624102.98
4818053-818053103.033103.39
5822462-822462103.588103.94
6810629-810629102.098102.44
30min1810914-810914102.134102.840.80102.65103.360.80
2814404-814404102.573103.10
3812788-812788102.370102.90
4824194-824194103.807104.33
5825178-825178103.930104.46
6811497-811497102.207102.72
45min1810467-810467102.078102.240.32102.77102.940.32
2813193-813193102.421103.12
3811944-811944102.264102.97
4814488-814488102.584103.28
5813044-813044102.402103.10
6807312-807312101.680102.37
极限1804570-804570101.335101.970.47102.19102.830.47
2810506-810506102.083102.95
3808766-808766101.863102.74
4811515-811515102.210103.08
5815264-815264102.682103.55
6806956-806956101.635102.49
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