氨溴酸替格列净片项目信息
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%
114.683373103369803370853374313371243371860.06
214.573355533355253355390.01
单位质量响应值RSD%判断
22969.0723029.440.19数据可信
供试品溶液-2025011421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%
5min1186224-18622446.98546.925.1046.9846.925.10
2174716-17471644.08144.08
3203411-20341151.32151.32
4185373-18537346.77046.77
5182779-18277946.11646.12
6183194-18319446.22046.22
10min1352689-35268988.98489.461.6489.0689.541.64
2354063-35406389.33189.40
3363481-36348191.70791.79
4358633-35863390.48490.56
5351918-35191888.79088.87
6346784-34678487.49487.57
15min1397056-397056100.178100.322.02100.40100.552.02
2400032-400032100.929101.15
3403481-403481101.799102.04
4408307-408307103.017103.25
5388610-38861098.04798.27
6388320-38832097.97498.20
20min1396021-39602199.917100.471.68100.31100.871.68
2402489-402489101.549101.94
3401612-401612101.328101.74
4407231-407231102.745103.15
5390442-39044298.51098.90
6391473-39147398.77099.16
30min1393000-39300099.155100.341.9599.72100.901.95
2401750-401750101.363101.92
3404856-404856102.146102.72
4406907-406907102.664103.24
5389600-38960098.29798.85
6390016-39001698.40298.95
45min1394541-39454199.54499.871.81100.27100.601.80
2400968-400968101.165101.89
3399484-399484100.791101.54
4404585-404585102.078102.82
5386163-38616397.43098.15
6389269-38926998.21498.93
极限1386201-38620197.44099.312.2698.33100.202.25
2400181-400181100.967101.86
3399169-399169100.711101.63
4405115-405115102.212103.12
5385162-38516297.17798.06
6385753-38575397.32698.20
氨溴酸替格列净片项目信息
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%
114.683363363364453364753362173362183363380.04
214.573355933356233356080.01
单位质量响应值RSD%判断
22911.3123034.180.38数据可信
供试品溶液-2025011421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%
5min1182695-18269546.14846.353.3646.1546.353.36
2192018-19201848.50348.50
3175018-17501844.20944.21
4179377-17937745.31045.31
5183200-18320046.27546.28
6188709-18870947.66747.67
10min1353847-35384789.38088.001.8189.4688.071.81
2346847-34684787.61287.69
3340260-34026085.94886.02
4342168-34216886.43086.51
5355612-35561289.82689.90
6351452-35145288.77588.85
15min1398427-398427100.64199.392.19100.8799.622.19
2389820-38982098.46798.69
3389032-38903298.26898.48
4380288-38028896.05996.28
5402794-402794101.744101.97
6400602-400602101.190101.42
20min1398984-398984100.78199.152.20101.1899.542.20
2389644-38964498.42298.81
3385445-38544597.36297.74
4380449-38044996.10096.48
5401710-401710101.470101.87
6398922-398922100.766101.16
30min1398153-398153100.57298.822.29101.1399.382.29
2387775-38777597.95098.51
3384684-38468497.16997.71
4378284-37828495.55396.09
5399867-399867101.004101.57
6398617-398617100.689101.25
45min1397311-397311100.35998.782.46101.0999.502.46
2387299-38729997.83098.55
3385789-38578997.44898.15
4376356-37635695.06695.76
5402161-402161101.584102.32
6397425-397425100.388101.12
极限1398635-398635100.69398.762.55101.5999.652.54
2388742-38874298.19499.08
3381446-38144696.35197.22
4377608-37760895.38296.24
5401487-401487101.414102.32
6398038-398038100.542101.44
氨溴酸替格列净片项目信息
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%
114.683358693365953361003357663361883361040.10
214.573357503362163359830.10
单位质量响应值RSD%判断
22895.3723059.920.51数据可信
供试品溶液-2025011521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%
5min1175446-17544644.30843.545.1744.3143.545.16
2174406-17440644.04544.04
3160560-16056040.54840.55
4186945-18694547.21247.21
5168769-16876942.62142.62
6168229-16822942.48542.49
10min1336111-33611184.88285.302.1384.9685.372.12
2349486-34948688.26088.33
3341155-34115586.15686.22
4337587-33758785.25585.33
5333894-33389484.32384.39
6328264-32826482.90182.97
15min1382301-38230196.54798.162.9096.7698.382.89
2402177-402177101.567101.79
3398815-398815100.718100.93
4387022-38702297.74097.96
5390516-39051698.62298.83
6371380-37138093.78994.00
20min1380575-38057596.11198.803.0296.4999.183.02
2402391-402391101.621102.01
3402408-402408101.625102.00
4394923-39492399.735100.12
5393536-39353699.38599.76
6373514-37351494.32894.69
30min1380696-38069696.14298.402.7896.6898.942.78
2402402-402402101.624102.18
3400277-400277101.087101.64
4393018-39301899.25499.80
5386129-38612997.51498.06
6375322-37532294.78595.31
45min1382065-38206596.48898.522.7497.1899.232.74
2400235-400235101.076101.80
3400447-400447101.130101.85
4391583-39158398.89199.61
5393184-39318499.296100.00
6373212-37321294.25294.93
极限1380685-38068596.13998.102.9397.0098.972.93
2400151-400151101.055101.95
3401773-401773101.465102.35
4389576-38957698.38599.26
5386262-38626297.54898.42
6372149-37214993.98494.82
氨溴酸替格列净片项目信息
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%
114.683356413358863357693356813361633358280.07
214.573350783356753353760.13
单位质量响应值RSD%判断
22876.5723018.260.44数据可信
供试品溶液-2025011521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%
5min1179257-17925745.33044.914.0045.3344.914.00
2184874-18487446.75046.75
3169923-16992342.96942.97
4167620-16762042.38742.39
5182152-18215246.06246.06
6181712-18171245.95045.95
10min1330423-33042383.55686.532.6283.6386.612.62
2355566-35556689.91489.99
3340229-34022986.03586.11
4336280-33628085.03785.11
5341785-34178586.42986.51
6348894-34889488.22688.30
15min1381172-38117296.38999.582.4396.6099.802.43
2404086-404086102.183102.41
3389242-38924298.42998.64
4386639-38663997.77197.98
5397560-397560100.533100.75
6404067-404067102.178102.40
20min1381176-38117696.39099.572.2596.7799.962.25
2404343-404343102.248102.65
3388369-38836998.20998.59
4389547-38954798.50798.88
5397855-397855100.607101.00
6401321-401321101.484101.88
30min1381091-38109196.36899.302.1496.9099.852.14
2396639-396639100.300100.87
3388284-38828498.18798.73
4388096-38809698.14098.68
5397613-397613100.546101.10
6404420-404420102.268102.83
45min1379747-37974796.02899.372.4396.73100.092.43
2401419-401419101.509102.24
3385446-38544697.47098.18
4390944-39094498.86099.56
5395405-39540599.988100.71
6404872-404872102.382103.12
极限1380313-38031396.17198.942.0897.0399.822.08
2401342-401342101.489102.39
3384628-38462897.26398.13
4389474-38947498.48899.36
5392982-39298299.375100.27
6398843-398843100.857101.76
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