利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.034788194786424785334784524787314786350.04
215.014823454833464828460.15
单位质量响应值RSD%判断
31845.3132168.290.72数据可信
供试品溶液-24102101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%
5min195419-9541917.74517.625.3717.7417.625.39
2100429-10042918.67618.68
3100764-10076418.73918.74
488530-8853016.46416.46
590416-9041616.81416.81
693006-9300617.29617.30
10min1170981-17098131.79730.953.3831.8330.983.39
2174118-17411832.38032.41
3168431-16843131.32231.35
4163846-16384630.47030.50
5160604-16060429.86729.89
6160623-16062329.87029.90
15min1203777-20377737.89537.082.6737.9837.162.67
2207100-20710038.51338.60
3200072-20007237.20637.29
4194837-19483736.23336.31
5193331-19333135.95336.03
6197328-19732836.69636.77
20min1223920-22392041.64141.032.1941.7941.172.20
2227622-22762242.33042.48
3221100-22110041.11741.26
4216732-21673240.30540.44
5214266-21426639.84639.98
6220082-22008240.92841.07
30min1252712-25271246.99646.581.6847.2146.791.68
2255500-25550047.51447.73
3251813-25181346.82847.04
4245159-24515945.59145.80
5245457-24545745.64645.85
6252193-25219346.89947.11
45min1275871-27587151.30251.091.3751.6051.371.38
2277860-27786051.67251.97
3277216-27721651.55351.84
4270756-27075650.35150.63
5269190-26919050.06050.34
6277326-27732651.57351.86
60min1290780-29078054.07553.680.9554.4554.050.95
2290457-29045754.01554.40
3289455-28945553.82954.21
4285606-28560653.11353.48
5284825-28482552.96853.33
6290818-29081854.08254.45
极限1298394-29839455.49155.310.9755.9655.770.98
2297572-29757255.33855.81
3300613-30061355.90456.37
4293926-29392654.66055.11
5294046-29404654.68255.13
6300030-30003055.79556.26
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.034813304812834813054807684810654811500.05
215.014877824874364876090.06
单位质量响应值RSD%判断
32012.6432485.611.04数据可信
供试品溶液-1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%
5min1102276-10227618.87719.131.3218.8819.131.32
2102564-10256418.93118.93
3104238-10423819.24019.24
4102672-10267218.95018.95
5105750-10575019.51919.52
6104364-10436419.26319.26
10min1164303-16430330.32629.861.2230.3629.901.23
2160480-16048029.62029.65
3163180-16318030.11930.15
4163101-16310130.10430.14
5159564-15956429.45129.48
6160153-16015329.56029.59
15min1190695-19069535.19734.841.2535.2834.921.24
2187115-18711534.53634.62
3189401-18940134.95835.04
4191769-19176935.39535.48
5185441-18544134.22734.31
6188059-18805934.71134.79
20min1211492-21149239.03638.301.5239.1838.451.51
2205059-20505937.84837.99
3208389-20838938.46338.60
4210407-21040738.83538.98
5203381-20338137.53937.68
6206470-20647038.10938.25
30min1237706-23770643.87443.111.4344.0843.321.43
2231289-23128942.69042.89
3233993-23399343.18943.39
4236931-23693143.73143.94
5229011-22901142.26942.47
6232603-23260342.93243.13
45min1261524-26152448.27047.721.1448.5548.001.14
2255607-25560747.17847.45
3259961-25996147.98248.26
4261740-26174048.31048.59
5255011-25501147.06847.34
6257510-25751047.52947.80
60min1277766-27776651.26850.621.1951.6350.981.20
2271128-27112850.04350.39
3276094-27609450.96051.32
4277370-27737051.19551.55
5270155-27015549.86350.21
6273161-27316150.41850.77
极限1294568-29456854.36953.750.9554.8154.190.94
2288902-28890253.32453.76
3291624-29162453.82654.27
4294299-29429954.32054.76
5288320-28832053.21653.65
6289485-28948553.43153.87
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.034879044876454884584883984885604881930.09
215.014873354874844874100.03
单位质量响应值RSD%判断
32481.2432472.350.02数据可信
供试品溶液-2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%
5min1117754-11775421.58122.402.0721.5822.402.08
2124833-12483322.87822.88
3123299-12329922.59722.60
4124014-12401422.72822.73
5121980-12198022.35522.36
6121335-12133522.23722.24
10min1158114-15811428.97729.711.4429.0129.741.44
2163476-16347629.96030.00
3164533-16453330.15430.19
4163616-16361629.98630.02
5161377-16137729.57529.61
6161444-16144429.58829.62
15min1182322-18232233.41434.071.2233.5034.151.22
2188387-18838734.52634.61
3188277-18827734.50534.59
4185860-18586034.06234.15
5185395-18539533.97734.06
6185046-18504633.91334.00
20min1200907-20090736.82037.301.0836.9637.441.08
2206481-20648137.84237.99
3205739-20573937.70637.85
4203343-20334337.26737.41
5201977-20197737.01637.16
6202547-20254737.12137.26
30min1228088-22808841.80242.030.8342.0042.240.83
2230232-23023242.19442.40
3232665-23266542.64042.85
4228617-22861741.89842.11
5227429-22742941.68141.89
6228934-22893441.95742.16
45min1252127-25212746.20746.500.7146.4846.780.70
2255831-25583146.88647.16
3256197-25619746.95347.23
4252679-25267946.30846.58
5252824-25282446.33546.61
6252834-25283446.33746.61
60min1267151-26715148.96149.230.5749.3149.580.57
2269130-26913049.32349.68
3271330-27133049.72650.08
4268690-26869049.24349.60
5267599-26759949.04349.39
6267761-26776149.07249.42
极限1284077-28407752.06352.320.3952.4952.750.40
2285949-28594952.40652.85
3287012-28701252.60053.04
4286200-28620052.45252.89
5284759-28475952.18852.62
6284822-28482252.19952.63
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