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%
110.153213983216023205753216583217403213950.15
210.173199913218213209060.41
单位质量响应值RSD%判断
31664.5331554.180.25数据可信
供试品溶液-JPS7149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%
5min145894-4589413.01512.463.8013.0112.463.80
241238-4123811.69511.69
344176-4417612.52812.53
445222-4522212.82412.82
544161-4416112.52412.52
642932-4293212.17512.17
10min183805-8380523.76623.452.2023.7923.472.21
279609-7960922.57622.60
382140-8214023.29423.31
485032-8503224.11424.14
582720-8272023.45823.48
682799-8279923.48123.50
15min1103271-10327129.28629.392.3229.3529.452.32
2100618-10061828.53428.59
3101906-10190628.89928.96
4107580-10758030.50830.57
5104643-10464329.67529.74
6103747-10374729.42129.48
20min1120257-12025734.10333.751.6534.2133.861.65
2116830-11683033.13233.24
3117512-11751233.32533.43
4121656-12165634.50034.61
5120268-12026834.10734.22
6117547-11754733.33533.44
30min1142044-14204440.28239.791.8640.4539.951.86
2137670-13767039.04239.20
3137669-13766939.04139.20
4143624-14362440.73040.90
5142137-14213740.30840.47
6138711-13871139.33739.50
45min1167342-16734247.45646.711.9547.6946.941.95
2161640-16164045.83946.06
3161723-16172345.86346.09
4168469-16846947.77648.01
5166914-16691447.33547.57
6162102-16210245.97046.20
60min1186735-18673552.95651.841.8953.2752.151.88
2179681-17968150.95551.26
3179567-17956750.92351.23
4186633-18663352.92753.24
5184032-18403252.18952.50
6180096-18009651.07351.38
极限1216410-21641061.37160.561.6961.7760.961.68
2211574-21157460.00060.39
3209770-20977059.48859.88
4217967-21796761.81362.22
5215779-21577961.19261.59
6209863-20986359.51559.91
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%
110.154762144772294781334782514781074775870.19
210.174790224782604786410.12
单位质量响应值RSD%判断
47052.9147064.010.02数据可信
供试品溶液-JPS7664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%
5min148913-489139.3179.622.469.329.622.44
252334-523349.9699.97
349385-493859.4079.41
451090-510909.7329.73
550478-504789.6159.62
650926-509269.7019.70
10min187897-8789716.74317.112.0016.7617.132.00
291837-9183717.49417.51
389517-8951717.05217.07
492143-9214317.55217.57
589375-8937517.02517.04
688208-8820816.80216.82
15min1111623-11162321.26321.531.6921.3121.581.70
2116393-11639322.17122.22
3112785-11278521.48421.53
4113522-11352221.62421.67
5113044-11304421.53321.58
6110871-11087121.11921.16
20min1129728-12972824.71125.111.4324.7925.201.43
2135058-13505825.72725.81
3131740-13174025.09525.17
4132225-13222525.18725.27
5132081-13208125.16025.24
6130225-13022524.80624.89
30min1155567-15556729.63330.001.1729.7530.121.18
2160431-16043130.56030.69
3157462-15746229.99430.12
4157731-15773130.04630.17
5158149-15814930.12530.25
6155502-15550229.62129.74
45min1183101-18310134.87835.260.9235.0535.440.91
2187499-18749935.71635.89
3185925-18592535.41635.59
4185302-18530235.29835.47
5185657-18565735.36535.54
6183253-18325334.90735.08
60min1202741-20274138.61939.121.0238.8539.351.02
2207961-20796139.61439.85
3206195-20619539.27739.51
4205653-20565339.17439.41
5206615-20661539.35739.59
6202951-20295138.65938.89
极限1238386-23838645.40945.670.5445.7045.960.55
2241768-24176846.05446.36
3239952-23995245.70846.00
4240576-24057645.82646.12
5239155-23915545.55645.85
6238657-23865745.46145.75
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%
110.154780934787764774904771354761794775350.21
210.174805774808354807060.04
单位质量响应值RSD%判断
47047.7847267.060.33数据可信
供试品溶液-JPS7157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%
5min164783-6478312.31411.883.3712.3111.883.38
261626-6162611.71411.71
361917-6191711.77011.77
465159-6515912.38612.39
559625-5962511.33411.33
661808-6180811.74911.75
10min1101253-10125319.24718.213.5519.2718.233.55
296000-9600018.24818.27
395039-9503918.06618.09
497701-9770118.57218.59
592527-9252717.58817.61
692186-9218617.52317.54
15min1125214-12521423.80222.404.0423.8522.454.03
2116827-11682722.20722.26
3116459-11645922.13722.19
4121725-12172523.13823.19
5113306-11330621.53821.59
6113369-11336921.55021.60
20min1144219-14421927.41425.673.7327.5125.763.74
2134491-13449125.56525.65
3133373-13337325.35325.44
4136567-13656725.96026.05
5131868-13186825.06625.15
6129831-12983124.67924.76
30min1169563-16956332.23230.393.3832.3730.523.38
2159842-15984230.38430.51
3158667-15866730.16130.29
4160994-16099430.60330.74
5156572-15657229.76229.89
6153696-15369629.21629.34
45min1196342-19634237.32235.562.9437.5135.742.94
2187404-18740435.62335.80
3185494-18549435.26035.44
4189290-18929035.98236.17
5183488-18348834.87935.05
6180413-18041334.29434.47
60min1215615-21561540.98639.222.6341.2439.472.63
2206679-20667939.28739.53
3204522-20452238.87739.12
4208100-20810039.55739.80
5203779-20377938.73638.97
6199407-19940737.90538.14
极限1249246-24924647.37946.011.6747.7046.311.68
2241001-24100145.81146.12
3240194-24019445.65845.96
4243977-24397746.37746.69
5239254-23925445.47945.78
6238453-23845345.32745.62
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%
110.154764954786124764804787944776144775990.24
210.174829954808874819410.31
单位质量响应值RSD%判断
47054.0947388.500.51数据可信
供试品溶液-2024112221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%
5min1122165-12216523.19123.633.9223.1923.633.92
2127684-12768424.23924.24
3125816-12581623.88423.88
4129314-12931424.54824.55
5126028-12602823.92423.92
6115796-11579621.98221.98
10min1176731-17673133.54934.061.6633.5934.101.66
2181032-18103234.36634.41
3182486-18248634.64234.68
4179990-17999034.16834.21
5181326-18132634.42134.46
6174859-17485933.19433.23
15min1206385-20638539.17839.571.1439.2739.671.14
2209973-20997339.86039.96
3210637-21063739.98640.08
4208454-20845439.57139.67
5210389-21038939.93940.04
6204902-20490238.89738.99
20min1224230-22423042.56643.011.1142.7343.181.10
2227772-22777243.23843.40
3229514-22951443.56943.73
4225691-22569142.84343.01
5228869-22886943.44743.61
6223458-22345842.41942.58
30min1247954-24795447.07047.241.0047.3047.481.00
2250000-25000047.45847.69
3251258-25125847.69747.93
4248550-24855047.18347.42
5250857-25085747.62147.86
6244554-24455446.42446.65
45min1263766-26376650.07150.460.8350.3850.770.83
2267395-26739550.76051.08
3267184-26718450.72051.04
4265266-26526650.35650.67
5268376-26837650.94651.26
6262894-26289449.90650.21
60min1271945-27194551.62452.050.7452.0252.450.74
2275394-27539452.27952.68
3276269-27626952.44552.85
4273277-27327751.87752.27
5276238-27623852.43952.84
6272112-27211251.65652.04
极限1278506-27850652.86953.180.5853.3553.670.59
2281343-28134353.40853.89
3281725-28172553.48053.97
4280157-28015753.18353.67
5281343-28134353.40853.90
6277897-27789752.75453.23
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