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%
19.863173463173493175173169993170153172450.08
210.023169493168073168780.04
单位质量响应值RSD%判断
32174.9531624.551.23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%
5min154166-5416615.22217.037.5715.2217.027.56
261375-6137517.24817.25
367020-6702018.83418.83
458422-5842216.41816.42
558435-5843516.42216.42
664104-6410418.01518.01
10min1108359-10835930.45231.002.7030.4831.032.70
2109111-10911130.66330.69
3114682-11468232.22932.26
4110279-11027930.99131.02
5106650-10665029.97130.00
6112831-11283131.70831.74
15min1137813-13781338.72938.491.7738.8138.571.77
2135454-13545438.06638.15
3139808-13980839.29039.37
4137608-13760838.67138.75
5132915-13291537.35337.43
6138090-13809038.80738.89
20min1157343-15734344.21844.372.3744.3644.522.37
2154865-15486543.52143.66
3164377-16437746.19446.34
4158876-15887644.64844.79
5153756-15375643.20943.35
6158179-15817944.45244.60
30min1184569-18456951.86951.711.3752.0851.931.37
2182196-18219651.20251.42
3187676-18767652.74252.97
4183910-18391051.68451.90
5180410-18041050.70050.91
6185251-18525152.06052.28
45min1210347-21034759.11359.091.0159.4159.391.02
2208643-20864358.63458.94
3213059-21305959.87560.19
4211432-21143259.41859.72
5207066-20706658.19158.49
6210942-21094259.28059.59
60min1227206-22720663.85163.870.8064.2564.270.80
2225662-22566263.41763.82
3229605-22960564.52564.94
4227802-22780264.01864.42
5224775-22477563.16863.56
6228582-22858264.23864.64
极限1244488-24448868.70868.950.6569.2169.460.66
2244455-24445568.69869.20
3247739-24773969.62170.14
4245925-24592569.11169.62
5243281-24328168.36868.87
6246216-24621669.19369.71
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%
19.863173933175783176563176143175853175650.04
210.023177143177913177520.02
单位质量响应值RSD%判断
32207.4031711.781.10数据可信
供试品溶液-2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%
5min1129785-12978536.40436.336.6736.4036.336.67
2120499-12049933.79933.80
3118319-11831933.18833.19
4140501-14050139.41039.41
5135621-13562138.04138.04
6132377-13237737.13137.13
10min1181102-18110250.79851.744.0550.8651.804.05
2177111-17711149.67949.74
3176104-17610449.39649.45
4192638-19263854.03454.10
5192742-19274254.06354.13
6187134-18713452.49052.55
15min1205303-20530357.58758.712.8357.7358.862.84
2204881-20488157.46857.61
3202630-20263056.83756.97
4215091-21509160.33260.49
5216988-21698860.86461.02
6210978-21097859.17859.33
20min1221369-22136962.09362.992.1162.3363.242.12
2221106-22110662.01962.25
3219430-21943061.54961.78
4229243-22924364.30264.56
5230921-23092164.77265.03
6225421-22542163.23063.48
30min1240425-24042567.43868.151.5767.7868.501.59
2240236-24023667.38567.72
3238852-23885266.99767.33
4246188-24618869.05569.42
5248542-24854269.71570.08
6243493-24349368.29968.65
45min1256903-25690372.06072.501.2372.5272.961.24
2256015-25601571.81172.26
3254810-25481071.47371.92
4260435-26043573.05173.53
5263334-26333473.86474.34
6259278-25927872.72673.19
60min1266760-26676074.82574.971.0175.4075.551.03
2264809-26480974.27874.85
3264201-26420174.10774.67
4267977-26797775.16675.77
5271644-27164476.19576.80
6268232-26823275.23875.83
极限1274169-27416976.90377.030.7877.6177.740.79
2272672-27267276.48377.18
3272627-27262776.47177.16
4274732-27473277.06177.79
5278430-27843078.09978.83
6275112-27511277.16877.88
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%
19.863170133169933169953170483160273168150.14
210.023196153197853197000.04
单位质量响应值RSD%判断
32131.3431906.190.50数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199135-9913527.75427.074.0727.7527.074.07
291672-9167225.66525.66
394204-9420426.37426.37
495437-9543726.71926.72
596791-9679127.09827.10
6102872-10287228.80028.80
10min1139349-13934939.01338.631.3539.0638.671.35
2135668-13566837.98238.02
3137209-13720938.41438.46
4136402-13640238.18838.23
5138703-13870338.83238.88
6140499-14049939.33539.38
15min1160477-16047744.92844.761.0845.0444.871.08
2157645-15764544.13544.24
3159048-15904844.52844.64
4158609-15860944.40544.51
5161780-16178045.29345.40
6161765-16176545.28845.40
20min1176081-17608149.29649.240.9349.4849.420.93
2174521-17452148.86049.04
3175364-17536449.09649.28
4173818-17381848.66348.85
5177903-17790349.80649.99
6177570-17757049.71349.90
30min1196941-19694155.13655.120.9655.4055.380.97
2195955-19595554.86055.12
3196837-19683755.10755.37
4194309-19430954.40054.66
5200090-20009056.01856.29
6197146-19714655.19455.47
45min1217032-21703260.76160.820.7861.1261.170.79
2215892-21589260.44260.79
3217492-21749260.89061.25
4215127-21512760.22860.58
5219992-21999261.59061.95
6217844-21784460.98961.35
60min1230557-23055764.54864.660.6465.0165.110.64
2229993-22999364.39064.84
3230705-23070564.58965.05
4231353-23135364.77165.22
5233614-23361465.40465.87
6229415-22941564.22864.69
极限1245349-24534968.68968.710.7269.2669.280.72
2244310-24431068.39868.96
3247318-24731869.24069.81
4243702-24370268.22868.79
5247788-24778869.37269.95
6244053-24405368.32668.90
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%
19.863178693182613178723179003177543179310.07
210.023169983170993170480.03
单位质量响应值RSD%判断
32244.5231641.521.34数据可信
供试品溶液-2批-pH4.5(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%
5min1235579-23557966.11568.526.3366.1268.526.33
2262792-26279273.75273.75
3238842-23884267.03167.03
4245870-24587069.00369.00
5259857-25985772.92972.93
6221926-22192662.28362.28
10min1306595-30659586.04686.562.8986.1686.682.89
2316790-31679088.90789.03
3301686-30168684.66884.78
4308969-30896986.71286.83
5320053-32005389.82389.94
6296575-29657583.23483.34
15min1335553-33555394.17392.662.2094.4392.922.20
2336566-33656694.45794.73
3323859-32385990.89191.14
4329243-32924392.40292.66
5336283-33628394.37894.65
6319504-31950489.66989.91
20min1342208-34220896.04194.671.9296.4595.081.92
2339289-33928995.22195.65
3329540-32954092.48592.89
4338966-33896695.13195.54
5344587-34458796.70897.14
6329274-32927492.41192.80
30min1347234-34723497.45196.281.8298.0296.851.83
2344536-34453696.69497.28
3335527-33552794.16694.72
4345827-34582797.05697.63
5350048-35004898.24198.83
6335238-33523894.08494.63
45min1349205-34920598.00497.401.9698.7498.131.96
2353639-35363999.249100.00
3338217-33821794.92095.64
4347754-34775497.59798.33
5353929-35392999.330100.08
6339569-33956995.30096.00
60min1350022-35002298.23497.191.7499.1398.081.74
2346444-34644497.22998.14
3338341-33834194.95595.83
4347424-34742497.50498.40
5354772-35477299.567100.49
6340836-34083695.65696.52
极限1353446-35344699.19597.751.48100.2598.801.48
2348483-34848397.80298.88
3341111-34111195.73396.76
4349817-34981798.17699.24
5353492-35349299.207100.29
6343367-34336796.36697.39
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