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%
19.993356453358063355753355423362903357720.10
210.013375793370103372940.12
单位质量响应值RSD%判断
33610.8133695.700.18数据可信
供试品溶液-2024112221-1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%
5min187059-8705923.18921.495.6023.1921.495.59
277402-7740220.61720.62
375720-7572020.16920.17
478451-7845120.89720.90
585230-8523022.70222.70
680227-8022721.37021.37
10min1133789-13378935.63734.971.4035.6835.001.40
2129851-12985134.58834.62
3128878-12887834.32834.36
4130824-13082434.84734.88
5132776-13277635.36735.40
6131575-13157535.04735.08
15min1161474-16147443.01142.681.1243.1142.771.11
2159684-15968442.53442.63
3156952-15695241.80641.90
4161349-16134942.97843.07
5160232-16023242.68042.78
6161655-16165543.05943.15
20min1179959-17995947.93547.901.0248.1048.061.02
2179838-17983847.90248.07
3176426-17642646.99447.15
4181168-18116848.25748.42
5179836-17983647.90248.07
6181653-18165348.38648.55
30min1208037-20803755.41455.091.1355.6655.341.13
2207448-20744855.25755.50
3202766-20276654.01054.25
4208417-20841755.51555.76
5205422-20542254.71754.96
6208930-20893055.65155.90
45min1232530-23253061.93861.831.1762.2862.161.17
2234266-23426662.40062.73
3227529-22752960.60660.93
4234208-23420862.38562.72
5230238-23023861.32761.67
6233872-23387262.29562.63
60min1247900-24790066.03266.071.0366.4866.511.03
2250808-25080866.80667.25
3243609-24360964.88965.32
4249921-24992166.57067.01
5247106-24710665.82066.26
6248930-24893066.30666.75
极限1263438-26343870.17070.260.6670.7370.810.66
2265676-26567670.76771.32
3260667-26066769.43269.97
4264700-26470070.50771.06
5263612-26361270.21770.77
6264489-26448970.45071.00
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%
19.993408363403173405903403293403503404840.07
210.013415413419183417300.08
单位质量响应值RSD%判断
34082.4834138.860.12数据可信
供试品溶液-2024112221-1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%
5min1102073-10207326.82424.816.9626.8224.816.96
298203-9820325.80725.81
3100428-10042826.39226.39
489476-8947623.51423.51
589560-8956023.53623.54
686749-8674922.79722.80
10min1142839-14283937.53736.912.4937.5836.952.50
2142574-14257437.46737.51
3144693-14469338.02438.07
4138427-13842736.37736.42
5138778-13877836.47036.51
6135350-13535035.56935.61
15min1168349-16834944.24143.921.4644.3544.021.46
2169618-16961844.57444.68
3169777-16977744.61644.72
4165074-16507443.38043.48
5165877-16587743.59143.69
6164146-16414643.13643.23
20min1185556-18555648.76348.660.8848.9448.840.89
2187263-18726349.21149.39
3186737-18673749.07349.25
4183450-18345048.20948.38
5184511-18451148.48848.66
6183497-18349748.22248.39
30min1208965-20896554.91454.990.5155.1855.250.52
2210716-21071655.37455.64
3210318-21031855.27055.53
4208158-20815854.70254.95
5209128-20912854.95755.21
6208213-20821354.71754.97
45min1229756-22975660.37860.480.5460.7360.830.54
2230812-23081260.65661.01
3232190-23219061.01861.37
4229168-22916860.22360.57
5230091-23009160.46660.81
6228803-22880360.12860.47
60min1242585-24258563.74963.820.3764.2064.270.37
2243223-24322363.91764.37
3244238-24423864.18464.64
4242444-24244463.71264.16
5243018-24301863.86364.31
6241584-24158463.48663.93
极限1255177-25517767.05866.950.4067.6267.500.40
2254106-25410666.77767.34
3256173-25617367.32067.88
4253306-25330666.56767.12
5254538-25453866.89167.44
6255240-25524067.07567.62
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