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430060-202303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%
110.103230023224073221533216233221073222580.16
210.093231983234563233270.06
单位质量响应值RSD%判断
31906.7332044.300.31数据可信
供试品溶液-2024122621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%
5min194994-9499426.63122.7611.2326.6322.7611.24
267215-6721518.84318.84
383618-8361823.44223.44
484164-8416423.59523.59
577773-7777321.80321.80
679418-7941822.26422.26
10min1139595-13959539.13436.704.8839.1836.744.89
2122146-12214634.24334.27
3133025-13302537.29237.33
4134228-13422837.63037.67
5124933-12493335.02435.06
6131569-13156936.88436.92
15min1162287-16228745.49644.332.9345.6144.432.93
2153459-15345943.02143.11
3158939-15893944.55744.66
4163817-16381745.92546.03
5152253-15225342.68342.78
6158016-15801644.29844.40
20min1179571-17957150.34149.592.3950.5349.762.40
2173513-17351348.64348.80
3176880-17688049.58749.76
4183297-18329751.38651.56
5171494-17149448.07748.24
6176511-17651149.48349.66
30min1201561-20156156.50656.641.7856.7856.901.78
2200890-20089056.31856.56
3202824-20282456.86057.12
4208302-20830258.39658.66
5197297-19729755.31055.56
6201463-20146356.47856.73
45min1224593-22459362.96363.461.5663.3363.811.56
2228092-22809263.94364.28
3226952-22695263.62463.98
4231945-23194565.02465.39
5221586-22158662.12062.46
6225067-22506763.09563.44
60min1238903-23890366.97467.841.4567.4468.291.45
2243510-24351068.26668.71
3242807-24280768.06968.53
4247640-24764069.42469.89
5237971-23797166.71367.15
6241091-24109167.58868.04
极限1254079-25407971.22972.061.0171.8172.631.01
2257669-25766972.23572.79
3256866-25686672.01072.58
4261476-26147673.30273.89
5254901-25490171.45972.01
6257313-25731372.13572.70
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430060-202303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%
110.103218583220223223383223713223743221930.08
210.093235593230623233100.11
单位质量响应值RSD%判断
31900.3032042.620.32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%
5min1134900-13490037.82337.694.2637.8237.694.25
2139912-13991239.22839.23
3133817-13381737.51937.52
4140531-14053139.40239.40
5132468-13246837.14137.14
6124851-12485135.00535.01
10min1188617-18861752.88453.333.1352.9553.393.13
2192898-19289854.08454.15
3190928-19092853.53253.59
4198387-19838755.62355.69
5190183-19018353.32353.38
6180225-18022550.53150.59
15min1213461-21346159.84960.502.1660.0060.662.16
2217886-21788661.09061.25
3214625-21462560.17660.33
4223643-22364362.70462.86
5215226-21522660.34460.50
6209878-20987858.84558.99
20min1229537-22953764.35764.921.6564.6165.171.66
2232132-23213265.08465.34
3230294-23029464.56964.82
4238489-23848966.86767.13
5231509-23150964.91065.16
6227231-22723163.71063.95
30min1248808-24880869.76070.101.2870.1270.461.28
2250623-25062370.26970.63
3248644-24864469.71470.07
4255924-25592471.75572.13
5249441-24944169.93770.30
6246603-24660369.14269.49
45min1262701-26270173.65574.171.1774.1374.651.18
2265378-26537874.40674.89
3263668-26366873.92674.40
4270266-27026675.77676.27
5263880-26388073.98674.46
6261424-26142473.29773.76
60min1270541-27054175.85376.491.3576.4577.101.35
2273772-27377276.75977.37
3271252-27125276.05376.65
4279711-27971178.42479.04
5272145-27214576.30376.90
6269541-26954175.57376.16
极限1276595-27659577.55177.881.0278.2778.601.02
2278546-27854678.09878.83
3275597-27559777.27178.00
4282931-28293179.32780.08
5277558-27755877.82178.55
6275309-27530977.19077.90
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430060-202303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%
110.103217683226333224253226663221973223380.12
210.093226353225003225680.03
单位质量响应值RSD%判断
31914.6531969.080.13数据可信
供试品溶液-2024122621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%
5min199142-9914227.82326.506.2627.8226.506.26
2102266-10226628.69928.70
391945-9194525.80325.80
489047-8904724.99024.99
587370-8737024.51924.52
696816-9681627.17027.17
10min1145875-14587540.93840.162.3740.9840.202.37
2147583-14758341.41741.46
3143100-14310040.15940.20
4139046-13904639.02139.06
5139520-13952039.15439.20
6143414-14341440.24740.29
15min1169204-16920447.48547.011.5347.6047.121.54
2171476-17147648.12248.24
3167855-16785547.10647.22
4164861-16486146.26646.37
5164976-16497646.29846.40
6166806-16680646.81246.92
20min1184463-18446351.76751.701.1651.9651.891.16
2187826-18782652.71152.91
3185082-18508251.94052.13
4181903-18190351.04851.23
5182481-18248151.21151.39
6183697-18369751.55251.74
30min1205501-20550157.67157.601.1657.9557.871.16
2208748-20874858.58258.87
3207061-20706158.10958.38
4204408-20440857.36457.63
5203062-20306256.98657.25
6202620-20262056.86257.14
45min1224819-22481963.09263.210.7363.4763.580.73
2227748-22774863.91464.30
3226680-22668063.61463.99
4224517-22451763.00763.37
5223433-22343362.70363.07
6224263-22426362.93663.31
60min1235546-23554666.10266.510.7766.5866.990.77
2239767-23976767.28767.78
3238620-23862066.96567.44
4236597-23659766.39766.87
5235179-23517965.99966.47
6236259-23625966.30366.78
极限1247206-24720669.37569.710.7969.9770.300.80
2250910-25091070.41471.02
3250427-25042770.27970.87
4248822-24882269.82870.41
5246283-24628369.11669.69
6246774-24677469.25369.84
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