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%
114.476689836695956695696694286694606694070.04
214.566691256691226691240.01
单位质量响应值RSD%判断
46261.7145956.320.47数据可信
供试品溶液-2025011021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%
5min1289312-28931236.41032.3522.6536.4132.3522.65
2301972-30197238.00338.00
3179137-17913722.54422.54
4188330-18833023.70123.70
5310170-31017039.03539.03
6273450-27345034.41434.41
10min1552174-55217469.49163.0016.8569.5563.0616.86
2565790-56579071.20571.27
3386990-38699048.70348.74
4399578-39957850.28750.33
5569001-56900171.60971.67
6530119-53011966.71666.77
15min1707180-70718088.99982.7712.8989.1882.9312.91
2724810-72481091.21791.40
3543605-54360568.41368.53
4555654-55565469.92970.05
5724670-72467091.20091.38
6690087-69008786.84887.02
20min1772819-77281997.25993.438.3397.5893.728.36
2793416-79341699.852100.19
3660317-66031783.10183.33
4667489-66748984.00484.24
5793900-79390099.912100.25
6766335-76633596.44396.76
30min1777288-77728897.82298.911.2198.3199.371.22
2796412-796412100.229100.73
3787396-78739699.09499.47
4780725-78072598.25498.63
5797681-797681100.388100.89
6776286-77628697.69698.17
45min1776590-77659097.73499.141.1698.3899.761.16
2794409-79440999.976100.64
3792360-79236099.719100.26
4788180-78818099.19399.74
5798167-798167100.449101.12
6776862-77686297.76898.41
极限1773137-77313797.29998.851.2798.1199.631.26
2793515-79351599.864100.70
3791482-79148299.608100.31
4786001-78600198.91899.63
5795274-795274100.085100.92
6773302-77330297.32098.12
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%
114.476688246693926688416689726691296690320.04
214.566721026720116720560.01
单位质量响应值RSD%判断
46235.8046157.690.12数据可信
供试品溶液-2025011021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%
5min1250128-25012831.41933.3922.5731.4233.3822.57
2316220-31622039.72039.72
3291715-29171536.64236.64
4298226-29822637.46037.46
5151655-15165519.04919.05
6286790-28679036.02436.02
10min1490682-49068261.63464.1617.5761.6964.2217.57
2593593-59359374.56174.63
3551290-55129069.24769.31
4555181-55518169.73669.80
5340910-34091042.82242.85
6533278-53327866.98567.05
15min1656010-65601082.40183.4813.8682.5683.6413.87
2750236-75023694.23794.43
3712038-71203889.43989.62
4701296-70129688.09088.27
5488155-48815561.31761.42
6679822-67982285.39285.56
20min1758594-75859495.28793.999.7295.5894.299.74
2800806-800806100.589100.94
3790396-79039699.28299.61
4776428-77642897.52797.85
5603850-60385075.85076.05
6759643-75964395.41995.73
30min1786320-78632098.77097.773.1699.2298.233.20
2802463-802463100.797101.31
3797666-797666100.195100.69
4783627-78362798.43198.92
5736511-73651192.51392.84
6763765-76376595.93696.41
45min1785552-78555298.67398.512.0099.2999.132.03
2806299-806299101.279101.96
3796668-796668100.069100.73
4780531-78053198.04298.69
5773330-77333097.13897.62
6763062-76306295.84896.48
极限1780970-78097098.09898.101.6498.8898.891.67
2799020-799020100.365101.22
3790348-79034899.275100.10
4780317-78031798.01698.83
5772395-77239597.02097.67
6762970-76297095.83796.63
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%
114.476692506695596692706689956693246692800.04
214.566683406689176686280.07
单位质量响应值RSD%判断
46252.9445922.250.51数据可信
供试品溶液-2025011121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%
5min1321096-32109640.42939.482.8740.4339.482.87
2310565-31056539.10339.10
3307733-30773338.74638.75
4309856-30985639.01439.01
5304216-30421638.30338.30
6327755-32775541.26741.27
10min1585097-58509773.66972.062.6073.7472.132.60
2572396-57239672.07072.13
3568785-56878571.61571.68
4559178-55917870.40570.47
5554873-55487369.86369.93
6593627-59362774.74374.81
15min1736410-73641092.72191.442.6992.9191.632.69
2732378-73237892.21392.40
3718157-71815790.42290.61
4712664-71266489.73189.91
5701615-70161588.34088.52
6756396-75639695.23795.43
20min1785013-78501398.84098.972.0499.1899.312.04
2801753-801753100.948101.29
3781421-78142198.38898.72
4787626-78762699.16999.50
5758603-75860395.51595.84
6801879-801879100.964101.32
30min1792363-79236399.76699.541.95100.27100.041.95
2806754-806754101.577102.08
3783865-78386598.69699.19
4794004-79400499.972100.47
5763760-76376096.16496.65
6802657-802657101.062101.58
45min1788283-78828399.25299.362.0999.93100.032.09
2805612-805612101.434102.11
3781212-78121298.36299.02
4795399-795399100.148100.81
5761150-76115095.83696.48
6803380-803380101.153101.84
极限1788543-78854399.28599.102.11100.1399.932.11
2804519-804519101.296102.14
3778000-77800097.95798.78
4792003-79200399.720100.55
5759002-75900295.56596.37
6800304-800304100.765101.62
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%
114.476706026685336685096691266698076693150.14
214.566688016680026684020.09
单位质量响应值RSD%判断
46255.3645906.730.54数据可信
供试品溶液-2025011121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%
5min1317783-31778340.01731.4234.7040.0231.4234.70
2132915-13291516.73816.74
3143970-14397018.13018.13
4294885-29488537.13437.13
5312094-31209439.30139.30
6295342-29534237.19237.19
10min1582962-58296273.41162.1522.5573.4862.2022.56
2333754-33375442.02942.06
3369531-36953146.53446.56
4549592-54959269.20869.27
5574656-57465672.36572.43
6550557-55055769.33069.39
15min1733582-73358292.37881.8417.2092.5782.0017.22
2483475-48347560.88360.98
3532069-53206967.00267.11
4710547-71054789.47789.65
5733044-73304492.31092.50
6706914-70691489.02089.20
20min1786560-78656099.04991.9811.4099.3992.2711.43
2598149-59814975.32375.52
3652961-65296182.22582.44
4773494-77349497.40497.73
5784167-78416798.74899.09
6787328-78732899.14699.47
30min1792115-79211599.74998.002.60100.2698.452.66
2739359-73935993.10593.43
3777654-77765497.92898.28
4778101-77810197.98498.47
5789946-78994699.47599.98
6792260-79226099.767100.26
45min1792466-79246699.79399.040.89100.4799.650.90
2786629-78662999.05899.54
3783947-78394798.72099.24
4775141-77514197.61198.26
5785684-78568498.93999.61
6794890-794890100.098100.76
极限1787945-78794599.22498.800.86100.0699.570.87
2785518-78551898.91899.56
3782097-78209798.48799.17
4772934-77293497.33398.15
5785978-78597898.97699.81
6792870-79287099.844100.67
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