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%
114.686740306733266735196737786733466736000.05
214.576725036728966727000.05
单位质量响应值RSD%判断
45885.5646170.210.44数据可信
供试品溶液-2025011021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%
5min1253101-25310131.90935.646.8431.9135.646.84
2277632-27763235.00235.00
3300598-30059837.89737.90
4307137-30713738.72138.72
5275883-27588334.78134.78
6281749-28174935.52135.52
10min1544561-54456168.65472.853.4768.7172.913.47
2574895-57489572.47872.54
3598049-59804975.39775.46
4591287-59128774.54574.61
5567066-56706671.49171.55
6591347-59134774.55274.61
15min1720639-72063990.85294.912.9791.0295.092.97
2748503-74850394.36594.54
3764580-76458096.39296.58
4768904-76890496.93797.13
5734888-73488892.64992.83
6779553-77955398.28098.46
20min1770430-77043097.129100.062.2097.45100.402.20
2786826-78682699.19799.53
3809367-809367102.038102.39
4812828-812828102.475102.83
5779030-77903098.21498.55
6803787-803787101.335101.68
30min1769448-76944897.00699.962.4297.49100.472.43
2784124-78412498.85699.36
3808425-808425101.920102.44
4815243-815243102.779103.30
5775023-77502397.70998.20
6805183-805183101.511102.03
45min1768765-76876596.92099.822.3197.56100.492.32
2784820-78482098.94499.61
3805246-805246101.519102.21
4813653-813653102.579103.27
5774677-77467797.66598.32
6803551-803551101.305101.99
极限1766346-76634696.61599.642.3297.42100.482.32
2784086-78408698.85199.68
3806271-806271101.648102.51
4809840-809840102.098102.96
5773424-77342497.50798.33
6802130-802130101.126101.98
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%
114.686727246726416732306737656735206731760.08
214.576718716716996717850.02
单位质量响应值RSD%判断
45856.6846107.410.39数据可信
供试品溶液-2025011021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%
5min1291466-29146636.78234.574.6636.7834.574.66
2265675-26567533.52733.53
3270861-27086134.18234.18
4288332-28833236.38736.39
5265107-26510733.45633.46
6261961-26196133.05933.06
10min1583436-58343673.62871.802.5573.6971.862.55
2548237-54823769.18669.24
3564818-56481871.27871.34
4587530-58753074.14574.21
5562700-56270071.01171.07
6566836-56683671.53371.59
15min1741185-74118593.53592.941.9593.7293.121.95
2708263-70826389.38189.55
3746737-74673794.23694.41
4738115-73811593.14893.33
5738393-73839393.18393.36
6746284-74628494.17994.35
20min1784099-78409998.95198.842.2299.2999.172.22
2750909-75090994.76395.08
3797922-797922100.696101.03
4784314-78431498.97899.32
5798951-798951100.825101.15
6782981-78298198.81099.14
30min1782391-78239198.73698.802.3099.2499.302.29
2750562-75056294.71995.20
3798758-798758100.801101.30
4784191-78419198.96399.47
5800447-800447101.014101.51
6781126-78112698.57699.07
45min1778969-77896998.30498.512.2898.9799.172.28
2747576-74757694.34294.98
3796730-796730100.545101.21
4782108-78210898.70099.37
5795464-795464100.385101.05
6782814-78281498.78999.45
极限1779969-77996998.43098.462.2199.2699.282.21
2748147-74814794.41495.21
3795840-795840100.433101.27
4780738-78073898.52799.36
5794499-794499100.264101.10
6782029-78202998.69099.51
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%
114.686728446731486730046726526737056730710.06
214.576680166680446680300.01
单位质量响应值RSD%判断
45849.5245849.690.01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%
5min1286891-28689136.30935.598.3336.3135.598.33
2321036-32103640.63140.63
3251496-25149631.83031.83
4276038-27603834.93634.94
5284801-28480136.04536.04
6267020-26702033.79433.79
10min1583886-58388673.89772.442.9773.9672.502.98
2598369-59836975.73075.80
3552094-55209469.87369.93
4569340-56934072.05672.11
5572704-57270472.48272.54
6557782-55778270.59370.65
15min1758787-75878796.03394.361.8296.2294.541.83
2761975-76197596.43696.63
3735954-73595493.14393.31
4750997-75099795.04795.23
5728694-72869492.22492.40
6737222-73722293.30393.48
20min1793837-793837100.46999.911.12100.81100.251.12
2800665-800665101.333101.69
3794466-794466100.548100.87
4786059-78605999.48499.82
5775451-77545198.14298.48
6786053-78605399.48399.81
30min1788964-78896499.85299.651.51100.36100.161.50
2803098-803098101.641102.16
3796327-796327100.784101.28
4785098-78509899.36399.87
5769211-76921197.35297.85
6781635-78163598.92499.42
45min1792627-792627100.31599.481.33100.99100.151.33
2798148-798148101.014101.71
3793248-793248100.394101.05
4782547-78254799.04099.71
5770414-77041497.50498.16
6779400-77940098.64199.30
极限1788749-78874999.82599.241.34100.67100.081.34
2797055-797055100.876101.74
3791260-791260100.142100.97
4779182-77918298.61499.45
5767508-76750897.13697.96
6781220-78122098.87299.70
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%
114.686731466724746729666730676728226728950.04
214.576724866721736723300.04
单位质量响应值RSD%判断
45837.5346144.820.48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%
5min1290036-29003636.59534.957.3136.5934.957.31
2275949-27594934.81734.82
3272112-27211234.33334.33
4266201-26620133.58733.59
5249524-24952431.48331.48
6308334-30833438.90338.90
10min1586575-58657574.01071.853.2874.0771.913.29
2559406-55940670.58270.64
3566951-56695171.53471.59
4550802-55080269.49669.55
5555462-55546270.08470.14
6597691-59769175.41275.48
15min1732160-73216092.37993.272.0292.5693.452.02
2732483-73248392.41992.59
3741463-74146393.55293.73
4719956-71995690.83991.01
5745910-74591094.11394.28
6763573-76357396.34296.53
20min1771228-77122897.30899.011.9597.6599.351.94
2783064-78306498.80199.13
3776711-77671198.00098.33
4771580-77158097.35297.68
5809249-809249102.105102.43
6796563-796563100.504100.86
30min1767633-76763396.85498.891.9297.3599.381.92
2783960-78396098.91499.41
3774125-77412597.67398.17
4774371-77437197.70498.19
5807633-807633101.901102.40
6794664-794664100.265100.78
45min1767143-76714396.79298.571.8497.4599.241.84
2780416-78041698.46799.13
3772534-77253497.47398.13
4770147-77014797.17197.82
5802551-802551101.260101.93
6794668-794668100.265100.95
极限1765542-76554296.59098.401.9297.4199.221.91
2775276-77527697.81998.64
3771801-77180197.38098.20
4770213-77021397.18097.99
5803513-803513101.381102.22
6792843-792843100.035100.89
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