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%
1 15.199775319749989766009764519734889758140.17
2 15.239752899747319750100.05
单位质量响应值RSD%判断
64240.5564019.040.25数据可信
供试品溶液-2024122521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%
5min1267064-26706424.88725.261.6624.8925.261.66
2275182-27518225.64325.64
3278016-27801625.90725.91
4269266-26926625.09225.09
5268937-26893725.06125.06
6267707-26770724.94724.95
10min1318510-31851029.68129.941.0329.7229.981.03
2325772-32577230.35730.40
3323748-32374830.16930.21
4320926-32092629.90629.95
5316779-31677929.51929.56
6321854-32185429.99230.03
15min1335856-33585631.29731.430.6431.3931.520.64
2338811-33881131.57331.67
3339326-33932631.62131.71
4339401-33940131.62831.72
5334492-33449231.17031.26
6335865-33586531.29831.39
20min1344797-34479732.13032.150.8032.2732.290.81
2345872-34587232.23132.38
3347998-34799832.42932.57
4346853-34685332.32232.47
5340068-34006831.69031.83
6344287-34428732.08332.23
30min1351971-35197132.79932.860.6133.0033.050.61
2353850-35385032.97433.17
3354460-35446033.03133.23
4354868-35486833.06933.27
5350667-35066732.67732.87
6349649-34964932.58232.78
45min1357758-35775833.33833.360.7933.5933.620.79
2355490-35549033.12733.38
3361865-36186533.72133.98
4360942-36094233.63533.89
5355148-35514833.09533.35
6356851-35685133.25433.51
60min1358341-35834133.39233.470.9433.7033.780.93
2360138-36013833.56033.87
3364533-36453333.96934.28
4359911-35991133.53933.85
5354361-35436133.02233.33
6357807-35780733.34333.65
极限1358336-35833633.39233.660.9433.7534.030.94
2364824-36482433.99734.36
3365604-36560434.06934.44
4361761-36176133.71134.08
5357732-35773233.33633.70
6359292-35929233.48133.84
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%
1 15.199788789803069800329796699817579801280.11
2 15.239817399825769821580.07
单位质量响应值RSD%判断
64524.5664488.380.04数据可信
供试品溶液-t3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%
5min1274512-27451225.43124.343.7625.4324.343.76
2264596-26459624.51324.51
3268523-26852324.87624.88
4267374-26737424.77024.77
5251925-25192523.33923.34
6249591-24959123.12323.12
10min1328371-32837130.42130.181.2230.4630.221.22
2328991-32899130.47830.52
3328151-32815130.40130.44
4324072-32407230.02330.06
5326578-32657830.25530.29
6318584-31858429.51429.55
15min1343951-34395131.86431.670.7931.9631.760.79
2344028-34402831.87131.96
3342827-34282731.76031.85
4340560-34056031.55031.64
5342497-34249731.73031.82
6336995-33699531.22031.31
20min1350533-35053332.47432.370.7332.6232.510.74
2352450-35245032.65232.80
3350626-35062632.48332.63
4349606-34960632.38832.53
5348047-34804732.24432.39
6345135-34513531.97432.11
30min1356337-35633733.01232.950.9833.2133.140.98
2359710-35971033.32433.52
3357212-35721233.09333.29
4355339-35533932.91933.12
5355906-35590632.97233.17
6349280-34928032.35832.55
45min1361874-36187433.52533.321.2133.7833.581.21
2360862-36086233.43133.69
3363487-36348733.67433.93
4358809-35880933.24133.49
5361733-36173333.51233.76
6351413-35141332.55632.80
60min1364476-36447633.76633.521.2134.0833.821.21
2364950-36495033.81034.12
3362875-36287533.61733.93
4361356-36135633.47733.78
5363712-36371233.69534.00
6353263-35326332.72733.03
极限1364172-36417233.73833.590.9034.1133.950.90
2364534-36453433.77134.14
3365747-36574733.88334.25
4361372-36137233.47833.84
5362708-36270833.60233.96
6356658-35665833.04133.40
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%
1 15.199788249788379791529785309794169789520.04
2 15.239806349793069799700.10
单位质量响应值RSD%判断
64447.1464344.710.12数据可信
供试品溶液-2024122621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%
5min1291031-29103127.00827.051.3027.0127.051.30
2295106-29510627.38627.39
3295467-29546727.42027.42
4288245-28824526.74926.75
5286073-28607326.54826.55
6292961-29296127.18727.19
10min1330933-33093330.71130.710.3830.7630.760.38
2331385-33138530.75330.80
3332766-33276630.88130.93
4330793-33079330.69830.74
5330884-33088430.70630.75
6328941-32894130.52630.57
15min1345326-34532632.04731.980.5732.1432.070.57
2343788-34378831.90432.00
3347906-34790632.28632.38
4344692-34469231.98832.08
5343544-34354431.88131.98
6342151-34215131.75231.85
20min1349987-34998732.47932.540.5332.6332.680.53
2350040-35004032.48432.63
3352919-35291932.75132.90
4352626-35262632.72432.87
5350144-35014432.49432.64
6348010-34801032.29632.44
30min1355721-35572133.01132.980.4533.2133.180.45
2352987-35298732.75832.96
3357484-35748433.17533.38
4356403-35640333.07533.28
5354371-35437132.88633.09
6355370-35537032.97933.18
45min1360302-36030233.43633.400.2833.7033.660.28
2360197-36019733.42733.69
3361155-36115533.51633.78
4359524-35952433.36433.62
5359976-35997633.40633.66
6358225-35822533.24433.50
60min1362892-36289233.67733.410.5633.9933.720.56
2358497-35849733.26933.58
3358606-35860633.27933.60
4357805-35780533.20533.52
5361663-36166333.56333.88
6360334-36033433.43933.75
极限1362592-36259233.64933.590.6434.0233.960.63
2361716-36171633.56833.94
3364854-36485433.85934.23
4361241-36124133.52433.89
5363346-36334633.71934.09
6358096-35809633.23233.60
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%
1 15.199716389717759722959697389712989713490.10
2 15.239883929862899873400.16
单位质量响应值RSD%判断
63946.6164828.630.97数据可信
供试品溶液-t3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%
5min1278638-27863825.86226.332.0425.8626.332.03
2290943-29094327.00527.00
3283060-28306026.27326.27
4279203-27920325.91525.91
5290822-29082226.99326.99
6279649-27964925.95625.96
10min1332694-33269430.88030.880.6830.9230.920.68
2336955-33695531.27531.32
3331421-33142130.76230.81
4331719-33171930.78930.83
5332653-33265330.87630.92
6330493-33049330.67530.72
15min1348407-34840732.33832.280.7632.4332.370.75
2352593-35259332.72732.82
3345133-34513332.03432.13
4346954-34695432.20332.30
5346341-34634132.14632.24
6346938-34693832.20232.30
20min1355225-35522532.97132.920.7233.1233.070.72
2358769-35876933.30033.45
3355682-35568233.01333.16
4354102-35410232.86733.01
5352585-35258532.72632.88
6351609-35160932.63532.78
30min1361112-36111233.51733.480.6833.7233.690.68
2364801-36480133.86034.07
3361914-36191433.59233.80
4359486-35948633.36633.57
5359041-35904133.32533.53
6358138-35813833.24133.44
45min1364630-36463033.84433.800.6034.1034.060.59
2365751-36575133.94834.21
3367410-36741034.10234.36
4362879-36287933.68133.94
5361683-36168333.57033.83
6362743-36274333.66933.93
60min1367088-36708834.07233.920.7334.3934.240.73
2369748-36974834.31934.64
3365986-36598633.97034.29
4362585-36258533.65433.97
5364069-36406933.79234.11
6363502-36350233.73934.05
极限1370095-37009534.35133.910.8834.7234.290.88
2367866-36786634.14434.52
3366123-36612333.98334.36
4363355-36335533.72634.10
5361670-36167033.56933.94
6363202-36320233.71134.08
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