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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 9.232976602972622982462983732970092977100.21
2 9.282981732985922983820.10
单位质量响应值RSD%判断
32254.6032153.230.23数据可信
供试品溶液-2批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227944-22794463.44966.754.9163.4566.754.91
2254641-25464170.88070.88
3248148-24814869.07269.07
4246151-24615168.51768.52
5225295-22529562.71162.71
6236568-23656865.84965.85
10min1317084-31708488.26188.960.9388.3789.070.93
2322195-32219589.68489.80
3324180-32418090.23690.35
4318057-31805788.53288.65
5316978-31697888.23188.34
6319063-31906388.81288.92
15min1336617-33661793.69894.460.5893.9594.720.58
2340952-34095294.90595.17
3341817-34181795.14595.41
4338760-33876094.29494.56
5337966-33796694.07394.33
6340015-34001594.64494.90
20min1344488-34448895.88996.560.5696.3096.980.57
2349239-34923997.21197.64
3348431-34843196.98697.41
4345269-34526996.10696.53
5345837-34583796.26496.67
6348071-34807196.88697.30
30min1350293-35029397.50598.470.7798.0799.050.78
2357656-35765699.554100.14
3355589-35558998.97999.56
4352302-35230298.06498.64
5351960-35196097.96998.54
6354838-35483898.77099.35
45min1354609-35460998.70699.620.7699.44100.360.77
2362013-362013100.767101.52
3359465-359465100.058100.81
4356077-35607799.11599.86
5356357-35635799.19399.92
6358859-35885999.889100.63
60min1355266-35526698.889100.110.8599.78101.020.85
2364054-364054101.335102.26
3360320-360320100.296101.21
4358026-35802699.657100.56
5358822-35882299.879100.78
6361481-361481100.619101.53
极限1355107-35510798.845100.070.9999.91101.150.99
2364755-364755101.530102.62
3360302-360302100.291101.38
4357762-35776299.584100.66
5357152-35715299.414100.48
6362053-362053100.778101.85
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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 9.232982782977302980112986912979382981300.13
2 9.282977602980102978850.06
单位质量响应值RSD%判断
32300.1132099.680.45数据可信
供试品溶液-2批-pH1.2(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1205665-20566557.25555.405.2257.2555.405.22
2180572-18057250.26950.27
3198262-19826255.19455.19
4202689-20268956.42656.43
5196308-19630854.65054.65
6210551-21055158.61558.62
10min1273825-27382576.23076.871.4676.3376.971.46
2270017-27001775.17075.25
3279138-27913877.70977.80
4276287-27628776.91577.01
5276054-27605476.85076.94
6281519-28151978.37278.47
15min1297499-29749982.82083.801.1683.0484.021.16
2296596-29659682.56982.78
3303995-30399584.62984.85
4300498-30049883.65583.88
5302432-30243284.19484.41
6305197-30519784.96385.19
20min1306787-30678785.40687.401.3285.7787.761.32
2312280-31228086.93587.28
3317024-31702488.25688.62
4313799-31379987.35887.72
5315286-31528687.77288.13
6318467-31846788.65889.03
30min1320497-32049789.22391.151.2689.7391.661.26
2327403-32740391.14591.64
3332340-33234092.52093.03
4325617-32561790.64891.16
5328515-32851591.45591.96
6330218-33021891.92992.45
45min1329233-32923391.65593.561.3692.3194.221.35
2338177-33817794.14594.79
3340919-34091994.90895.57
4332452-33245292.55193.21
5335676-33567693.44894.11
6340006-34000694.65495.32
60min1331117-33111792.17993.851.2792.9894.661.27
2337169-33716993.86494.66
3343149-34314995.52996.35
4334145-33414593.02293.83
5336884-33688493.78594.60
6340244-34024494.72095.55
极限1330953-33095392.13493.941.3893.0994.911.37
2337513-33751393.96094.92
3342577-34257795.37096.35
4333124-33312492.73893.71
5338819-33881994.32395.29
6341693-34169395.12396.11
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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 9.234811414800274806844804284797134803990.12
2 9.284810314815004812660.07
单位质量响应值RSD%判断
52047.5651860.560.26数据可信
供试品溶液-1批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1326167-32616756.27658.332.7756.2858.332.77
2330642-33064257.04857.05
3334274-33427457.67557.67
4351321-35132160.61660.62
5342818-34281859.14959.15
6343294-34329459.23159.23
10min1435178-43517875.08577.161.3675.1877.251.36
2447013-44701377.12777.22
3450694-45069477.76277.86
4448843-44884377.44277.54
5450717-45071777.76677.86
6450640-45064077.75277.85
15min1475580-47558082.05583.121.0682.2783.351.06
2480048-48004882.82683.05
3482715-48271583.28683.51
4478227-47822782.51282.74
5490114-49011484.56384.79
6483958-48395883.50183.73
20min1488646-48864684.31085.661.0884.6786.021.08
2495388-49538885.47385.83
3499003-49900386.09786.46
4493300-49330085.11385.48
5504335-50433587.01787.39
6498163-49816385.95286.32
30min1505957-50595787.29788.350.9787.7988.850.97
2509299-50929987.87388.38
3514403-51440388.75489.26
4508374-50837487.71488.22
5518913-51891389.53290.05
6515267-51526788.90389.41
45min1514784-51478488.82090.110.8889.4690.760.88
2523802-52380290.37691.03
3524113-52411390.42991.09
4519094-51909489.56390.22
5527810-52781091.06791.73
6523892-52389290.39191.05
60min1519701-51970189.66890.840.9790.4691.640.97
2523655-52365590.35091.15
3529453-52945391.35192.16
4523500-52350090.32391.13
5533583-53358392.06392.88
6528952-52895291.26492.07
极限1525062-52506290.59391.310.7291.5392.260.72
2527447-52744791.00491.96
3530572-53057291.54492.50
4525857-52585790.73091.69
5535075-53507592.32193.29
6531193-53119391.65192.61
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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 9.234798044813014795974800214801314801710.14
2 9.284809734790504800120.29
单位质量响应值RSD%判断
52022.8651725.430.41数据可信
供试品溶液-1批-pH1.2(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1296265-29626551.19648.872.9051.2048.872.90
2272302-27230247.05547.05
3286427-28642749.49649.50
4282797-28279748.86948.87
5281421-28142148.63148.63
6277561-27756147.96447.96
10min1381392-38139265.90665.460.5265.9965.540.52
2377414-37741465.21965.30
3381048-38104865.84765.93
4377880-37788065.29965.38
5378407-37840765.39065.47
6376764-37676465.10665.19
15min1412617-41261771.30271.170.4871.5071.360.48
2411640-41164071.13371.32
3415326-41532671.77071.96
4410776-41077670.98471.17
5411168-41116871.05271.24
6409587-40958770.77870.97
20min1430146-43014674.33174.240.3174.6574.550.31
2430536-43053674.39874.70
3430858-43085874.45474.77
4427549-42754973.88274.19
5430131-43013174.32874.64
6428391-42839174.02874.33
30min1450243-45024377.80477.840.3178.2478.280.31
2451252-45125277.97878.41
3451302-45130277.98778.42
4447758-44775877.37477.81
5451113-45111377.95478.39
6451106-45110677.95378.38
45min1463923-46392380.16880.370.4280.7480.940.41
2467885-46788580.85381.41
3466691-46669180.64681.21
4462733-46273379.96280.52
5465361-46536180.41680.98
6464078-46407880.19580.75
60min1472090-47209081.57981.490.4282.2882.180.41
2474593-47459382.01282.71
3472018-47201881.56782.27
4468706-46870680.99481.69
5471197-47119781.42582.12
6470676-47067681.33582.03
极限1477824-47782482.57082.360.6283.4183.200.62
2480681-48068183.06483.89
3476511-47651182.34383.18
4471724-47172481.51682.34
5477394-47739482.49683.33
6475651-47565182.19583.02
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