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%
114.476745776758996750916750146749186751000.08
214.566691296683826687560.08
单位质量响应值RSD%判断
46655.1545931.041.11数据可信
供试品溶液-2025011121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%
5min1293777-29377736.82735.629.4536.8335.629.45
2292216-29221636.63136.63
3292243-29224336.63436.63
4307583-30758338.55738.56
5287933-28793336.09436.09
6231075-23107528.96728.97
10min1543475-54347568.12868.358.0268.1968.408.02
2567418-56741871.12971.19
3558954-55895470.06870.13
4586891-58689173.57073.63
5553359-55335969.36769.43
6461184-46118457.81257.86
15min1700578-70057887.82287.956.2288.0088.126.22
2731612-73161291.71291.89
3712322-71232289.29489.47
4738300-73830092.55092.74
5709359-70935988.92289.10
6617475-61747577.40477.55
20min1772549-77254996.84496.413.5597.1696.733.56
2788435-78843598.83599.17
3776124-77612497.29297.62
4785008-78500898.40598.75
5777496-77749697.46497.79
6714789-71478989.60389.88
30min1774076-77407697.03598.250.9797.5298.740.95
2789104-78910498.91999.42
3779756-77975697.74798.24
4783034-78303498.15898.66
5781237-78123797.93398.42
6795625-79562599.736100.16
45min1773492-77349296.96298.201.0397.6198.841.01
2790001-79000199.03199.69
3779812-77981297.75498.41
4784712-78471298.36899.04
5777280-77728097.43798.09
6794861-79486199.641100.23
极限1774614-77461497.10397.750.6997.9198.560.67
2783402-78340298.20499.03
3776265-77626597.30998.12
4776975-77697597.39898.23
5778655-77865597.60998.42
6788861-78886198.88899.64
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%
114.476703756709456709576705736710196707740.05
214.566729056731256730150.03
单位质量响应值RSD%判断
46356.1946223.560.21数据可信
供试品溶液-2025011121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%
5min1305258-30525838.26633.9616.3038.2733.9616.29
2286996-28699635.97735.98
3206928-20692825.94025.94
4228128-22812828.59828.60
5318941-31894139.98239.98
6279239-27923935.00535.00
10min1574766-57476672.05165.9912.9672.1166.0412.96
2548942-54894268.81468.87
3419005-41900552.52552.57
4471718-47171859.13359.18
5601409-60140975.39175.46
6542574-54257468.01668.07
15min1735305-73530592.17686.2510.1392.3686.4210.14
2716733-71673389.84890.02
3569303-56930371.36671.50
4641973-64197380.47680.62
5755314-75531494.68494.88
6709773-70977388.97589.15
20min1794164-79416499.55495.966.2199.8996.276.23
2784872-78487298.38998.71
3675177-67517784.63884.89
4750195-75019594.04294.32
5797974-797974100.032100.38
6790811-79081199.13499.45
30min1794349-79434999.57799.181.10100.0899.651.14
2793134-79313499.42599.91
3774305-77430597.06597.46
4790519-79051999.09799.53
5798218-798218100.062100.58
6796380-79638099.832100.32
45min1791190-79119099.18199.060.9099.8599.700.94
2792073-79207399.29299.95
3777690-77769097.48998.04
4787398-78739898.70699.31
5796744-79674499.878100.56
6796359-79635999.829100.48
极限1790619-79061999.11098.751.1099.9499.551.14
2789200-78920098.93299.75
3770748-77074896.61997.33
4788572-78857298.85399.62
5792494-79249499.345100.19
6794787-79478799.632100.45
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%
114.476695456703806701096701446709106702180.08
214.566689086686946688010.03
单位质量响应值RSD%判断
46317.7645934.130.59数据可信
供试品溶液-2025011221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%
5min1306709-30670938.58537.623.5538.5937.623.55
2305224-30522438.39938.40
3300129-30012937.75837.76
4308231-30823138.77738.78
5280322-28032235.26635.27
6293675-29367536.94636.95
10min1587049-58704973.85471.973.0073.9272.033.01
2574337-57433772.25472.32
3579851-57985172.94873.01
4586247-58624773.75373.82
5542209-54220968.21268.27
6562686-56268670.78970.85
15min1748740-74874094.19592.492.4294.3892.672.42
2736533-73653392.65992.84
3747748-74774894.07094.25
4748804-74880494.20394.39
5704659-70465988.64988.82
6724588-72458891.15791.34
20min1797418-797418100.31999.501.04100.6699.831.05
2795531-795531100.082100.42
3794429-79442999.943100.28
4795050-795050100.021100.37
5775832-77583297.60397.92
6786981-78698199.00699.34
30min1799421-799421100.57199.671.14101.08100.171.14
2797547-797547100.335100.84
3795733-795733100.107100.61
4797199-797199100.291100.80
5775983-77598397.62298.11
6787638-78763899.08999.59
45min1795440-795440100.07099.301.05100.7599.971.06
2795597-795597100.090100.76
3793344-79334499.806100.48
4792289-79228999.674100.35
5774462-77446297.43198.08
6784902-78490298.74499.41
极限1795172-795172100.03699.200.98100.88100.030.98
2793619-79361999.841100.68
3790508-79050899.450100.29
4791657-79165799.594100.44
5774204-77420497.39998.21
6785949-78594998.87699.70
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%
114.476698426702046697236700946695906698910.04
214.566683296679626681460.04
单位质量响应值RSD%判断
46295.1645889.150.63数据可信
供试品溶液-2025011221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%
5min1281942-28194235.49632.9820.0035.5032.9820.00
2185700-18570023.37923.38
3292738-29273836.85536.85
4296556-29655637.33637.34
5309049-30904938.90838.91
6205903-20590325.92325.92
10min1548821-54882169.09564.8815.6869.1564.9315.68
2399378-39937850.28150.32
3556907-55690770.11370.17
4567915-56791571.49971.56
5591541-59154174.47374.54
6427349-42734953.80253.85
15min1707543-70754389.07885.1312.3989.2585.3012.40
2554853-55485369.85469.98
3724756-72475691.24591.42
4726399-72639991.45291.63
5756918-75691895.29495.48
6586786-58678673.87574.01
20min1781540-78154098.39494.907.6898.7295.207.70
2667805-66780584.07584.31
3790199-79019999.48499.81
4788052-78805299.21499.55
5802283-802283101.005101.35
6692928-69292887.23887.49
30min1789276-78927699.36899.171.1599.8599.631.19
2781487-78148798.38798.77
3790463-79046399.517100.01
4790047-79004799.46599.96
5800735-800735100.810101.33
6774275-77427597.47997.88
45min1789411-78941199.38599.311.09100.0499.931.13
2783967-78396798.69999.24
3792302-79230299.749100.41
4787991-78799199.20699.87
5802303-802303101.008101.69
6776700-77670097.78498.35
极限1787047-78704799.08799.071.3199.9199.871.34
2787392-78739299.13099.84
3790247-79024799.490100.32
4782257-78225798.48499.31
5803072-803072101.105101.96
6771603-77160397.14397.87
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