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)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%
115.024786714789294779814779754796184786350.15
215.044786234788624787420.04
单位质量响应值RSD%判断
31866.5131831.250.08数据可信
供试品溶液-2024122921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%
5min1127806-12780623.98125.636.5723.9825.636.56
2133565-13356525.06225.06
3132849-13284924.92724.93
4147965-14796527.76427.76
5147756-14775627.72427.72
6129656-12965624.32824.33
10min1177206-17720633.25034.683.4933.2934.723.49
2184923-18492334.69834.74
3181715-18171534.09634.14
4191858-19185835.99936.05
5193076-19307636.22836.27
6180159-18015933.80433.84
15min1204858-20485838.43939.762.5338.5339.862.53
2213350-21335040.03240.13
3209494-20949439.30939.41
4217319-21731940.77740.88
5218316-21831640.96441.07
6208017-20801739.03239.13
20min1223869-22386942.00643.141.6142.1743.301.61
2230459-23045943.24243.41
3228154-22815442.81042.97
4233769-23376943.86444.04
5233524-23352443.81843.99
6229626-22962643.08643.25
30min1247461-24746146.43347.110.9746.6647.350.98
2251853-25185347.25747.50
3251121-25112147.11947.35
4254078-25407847.67447.92
5252788-25278847.43247.68
6249185-24918546.75646.99
45min1265822-26582249.87850.260.6750.1850.580.68
2266835-26683550.06850.39
3269228-26922850.51750.83
4269772-26977250.61950.95
5269409-26940950.55150.88
6266195-26619549.94850.26
60min1275781-27578151.74651.960.4252.1452.360.43
2276068-27606851.80052.20
3277594-27759452.08752.48
4277867-27786752.13852.55
5278373-27837352.23352.64
6275860-27586051.76152.16
极限1283903-28390353.27053.400.5053.7553.880.51
2285271-28527153.52754.01
3284914-28491453.46053.94
4284882-28488253.45453.95
5286301-28630153.72054.22
6282162-28216252.94453.42
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)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%
115.024789764782954779494782804790054785010.10
215.044833964819614826780.22
单位质量响应值RSD%判断
31857.5932092.950.53数据可信
供试品溶液-2024122921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%
5min1125727-12572723.49825.374.6423.5025.374.64
2135476-13547625.32025.32
3144928-14492827.08727.09
4134671-13467125.17025.17
5138991-13899125.97725.98
6134580-13458025.15325.15
10min1178427-17842733.34734.632.2833.3934.682.28
2184729-18472934.52534.57
3191083-19108335.71335.76
4183779-18377934.34834.39
5186985-18698534.94734.99
6186879-18687934.92734.97
15min1207334-20733438.75039.801.5638.8439.901.58
2213106-21310639.82939.93
3217395-21739540.63040.74
4211798-21179839.58439.68
5213812-21381239.96140.06
6214273-21427340.04740.15
20min1226360-22636042.30643.171.1142.4743.341.11
2231275-23127543.22543.39
3234140-23414043.76043.93
4230613-23061343.10143.27
5231519-23151943.27043.44
6231988-23198843.35843.52
30min1249976-24997646.72047.260.6346.9547.500.64
2253358-25335847.35247.59
3253966-25396647.46547.71
4252640-25264047.21847.45
5252714-25271447.23147.47
6254530-25453047.57147.81
45min1267877-26787750.06550.360.3250.3750.680.33
2269503-26950350.36950.69
3269984-26998450.45950.78
4269813-26981350.42750.74
5269416-26941650.35350.67
6270265-27026550.51250.83
60min1278551-27855152.06052.050.1352.4552.450.14
2277975-27797551.95352.35
3279030-27903052.15052.56
4278285-27828552.01152.41
5278619-27861952.07352.48
6278483-27848352.04852.45
极限1287298-28729853.69553.380.4654.1753.870.45
2285839-28583953.42253.91
3285825-28582553.42053.92
4285660-28566053.38953.88
5283282-28328252.94553.43
6285830-28583053.42153.91
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)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%
115.024787904777564793054790274777944785340.15
215.044780034786874783450.11
单位质量响应值RSD%判断
31859.7931804.850.13数据可信
供试品溶液-JPS8079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%
5min181432-8143215.28816.9216.3915.2916.9216.38
276756-7675614.41014.41
377871-7787114.61914.62
4101271-10127119.01219.01
5113842-11384221.37221.37
689748-8974816.84916.85
10min1108940-10894020.45221.609.9620.4821.639.97
2104875-10487519.68919.71
3106290-10629019.95419.98
4122725-12272523.04023.07
5134414-13441425.23425.27
6113046-11304621.22321.25
15min1126664-12666423.77924.707.3823.8424.777.40
2123759-12375923.23423.29
3124668-12466823.40423.46
4138390-13839025.98026.05
5148232-14823227.82827.91
6127832-12783223.99824.06
20min1141904-14190426.64027.465.3126.7427.575.33
2140387-14038726.35526.45
3140420-14042026.36226.46
4152434-15243428.61728.73
5159181-15918129.88430.01
6143334-14333426.90927.01
30min1163957-16395730.78031.243.8830.9231.383.91
2161901-16190130.39430.53
3161369-16136930.29430.43
4171474-17147432.19132.35
5177123-17712333.25233.43
6162470-16247030.50130.65
45min1188408-18840835.37135.762.6935.5735.962.71
2188508-18850835.38935.58
3185911-18591134.90235.09
4194943-19494336.59736.81
5198584-19858437.28137.51
6186514-18651435.01535.21
60min1209231-20923139.28039.351.6739.5339.611.70
2207928-20792839.03539.28
3205536-20553638.58638.84
4212584-21258439.90940.18
5214847-21484740.33440.63
6207389-20738938.93439.19
极限1246016-24601646.18646.031.1146.5046.361.13
2245553-24555346.09946.41
3243267-24326745.66945.98
4246890-24689046.35046.69
5248568-24856846.66547.02
6240976-24097645.23945.56
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)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%
115.024789984771104785934783264777784781610.16
215.044788954778734783840.16
单位质量响应值RSD%判断
31834.9531807.450.07数据可信
供试品溶液-JPS8079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%
5min195387-9538717.91418.028.7617.9118.028.77
287192-8719216.37516.37
3109854-10985420.63120.63
4100667-10066718.90518.91
594155-9415517.68217.68
688417-8841716.60516.60
10min1121021-12102122.72822.645.5822.7622.675.58
2115951-11595121.77621.80
3132102-13210224.80924.84
4123375-12337523.17023.20
5117675-11767522.09922.13
6113159-11315921.25121.28
15min1136838-13683825.69825.734.2725.7725.804.28
2132892-13289224.95725.02
3147548-14754827.70927.79
4138853-13885326.07726.15
5134875-13487525.32925.40
6131119-13111924.62424.69
20min1151557-15155728.46228.342.9228.5728.452.93
2147604-14760427.72027.83
3158518-15851829.77029.89
4152442-15244228.62928.74
5148881-14888127.96028.07
6146322-14632227.47927.58
30min1169502-16950231.83232.022.2531.9932.172.26
2167137-16713731.38831.54
3177678-17767833.36833.54
4171392-17139232.18732.35
5169378-16937831.80931.96
6167792-16779231.51131.66
45min1193268-19326836.29636.581.3436.5136.801.35
2191644-19164435.99136.19
3199371-19937137.44237.67
4195384-19538436.69336.91
5194534-19453436.53336.74
6194647-19464736.55536.76
60min1212864-21286439.97640.251.2040.2540.521.21
2210813-21081339.59139.85
3218062-21806240.95241.24
4213621-21362140.11840.39
5214252-21425240.23640.51
6216346-21634640.63040.89
极限1245149-24514946.03946.410.6046.3846.750.61
2246128-24612846.22346.55
3249515-24951546.85947.22
4247269-24726946.43746.78
5247550-24755046.49046.83
6247234-24723446.43046.76
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