利伐沙班颗粒项目信息
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对照品来源中检院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800
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%
112.724923764927624921014913264907244918580.17
212.654886954880454883700.10
单位质量响应值RSD%判断
38668.0838606.320.12数据可信
影响因素30天-供试品溶液-2024010711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%
5min1163664-16366431.64231.012.2931.6431.002.29
2157624-15762430.47530.47
3160915-16091531.11131.11
4154410-15441029.85329.85
5163364-16336431.58431.58
6162330-16233031.38431.38
10min1210283-21028340.65640.520.9940.7140.570.99
2207044-20704440.02940.08
3210421-21042140.68240.73
4207686-20768640.15340.20
5209344-20934440.47440.53
6212751-21275141.13341.18
15min1232383-23238344.92845.080.7345.0545.200.73
2230863-23086344.63444.75
3234135-23413545.26745.39
4233431-23343145.13145.25
5232308-23230844.91445.03
6235746-23574645.57845.70
20min1245729-24572947.50947.720.8247.7047.910.82
2244235-24423547.22047.41
3248340-24834048.01348.21
4247861-24786147.92148.11
5245292-24529247.42447.62
6249422-24942248.22348.42
30min1262090-26209050.67250.780.6550.9551.050.64
2260556-26055650.37550.65
3263340-26334050.91351.19
4264267-26426751.09351.36
5260994-26099450.46050.73
6264596-26459651.15651.43
45min1274471-27447153.06553.180.5453.4253.540.54
2273661-27366152.90953.26
3275675-27567553.29853.66
4276175-27617553.39553.75
5273353-27335352.84953.21
6277034-27703453.56153.92
60min1281078-28107854.34354.420.3854.7954.870.38
2280312-28031254.19554.64
3281949-28194954.51154.96
4282747-28274754.66555.11
5280400-28040054.21254.66
6282509-28250954.61955.07
极限1286755-28675555.44055.420.2255.9855.960.22
2285846-28584655.26555.80
3286395-28639555.37155.91
4287374-28737455.56056.10
5286126-28612655.31955.86
6287267-28726755.53956.08
利伐沙班颗粒项目信息
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对照品来源中检院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800
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%
112.724898704900454902954904524906404902600.07
212.654902724899304901010.05
单位质量响应值RSD%判断
38542.4538743.160.37数据可信
影响因素30天-供试品溶液-2024010711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%
5min1147609-14760928.53431.104.8828.5331.104.89
2171408-17140833.13533.13
3162470-16247031.40731.41
4157789-15778930.50230.50
5162772-16277231.46531.47
6163184-16318431.54531.55
10min1203764-20376439.39040.581.7739.4440.631.77
2213829-21382941.33541.39
3209455-20945540.49040.54
4207970-20797040.20340.25
5211826-21182640.94841.00
6212697-21269741.11741.17
15min1230223-23022344.50445.131.0244.6245.241.02
2235142-23514245.45545.58
3232057-23205744.85944.98
4231924-23192444.83344.95
5236302-23630245.68045.80
6234960-23496045.42045.54
20min1246350-24635047.62247.911.0247.8148.111.02
2248127-24812747.96548.17
3245425-24542547.44347.64
4246142-24614247.58247.77
5252301-25230148.77248.97
6248726-24872648.08148.28
30min1264596-26459651.14951.110.5551.4251.380.55
2263849-26384951.00551.28
3262953-26295350.83251.11
4263709-26370950.97851.25
5267111-26711151.63551.91
6263995-26399551.03351.31
45min1277240-27724053.59353.520.5253.9553.880.52
2275933-27593353.34153.71
3275329-27532953.22453.58
4276198-27619853.39253.75
5279392-27939254.00954.37
6276952-27695253.53853.90
60min1287090-28709055.49754.850.8055.9455.300.79
2281759-28175954.46754.92
3281564-28156454.42954.88
4282932-28293254.69455.14
5285918-28591855.27155.73
6283242-28324254.75455.20
极限1288932-28893255.85455.720.5456.3956.260.54
2287315-28731555.54156.09
3286653-28665355.41355.95
4288085-28808555.69056.23
5290974-29097456.24856.79
6287431-28743155.56356.11
利伐沙班颗粒项目信息
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对照品来源中检院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800
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%
112.724898034907874897944901684902914901690.09
212.654895484887544891510.12
单位质量响应值RSD%判断
38535.3038668.060.25数据可信
影响因素30天-供试品溶液-2024010711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%
5min1158401-15840130.65329.895.0830.6529.885.08
2154344-15434429.86829.87
3154056-15405629.81229.81
4160973-16097331.15131.15
5159385-15938530.84330.84
6139467-13946726.98926.99
10min1206270-20627039.91639.761.7639.9739.811.77
2207536-20753640.16140.21
3205548-20554839.77739.83
4206835-20683540.02640.08
5208269-20826940.30340.35
6198363-19836338.38638.43
15min1228925-22892544.30144.510.8344.4244.630.83
2231071-23107144.71644.83
3229439-22943944.40044.52
4230657-23065744.63644.75
5232761-23276145.04345.16
6227304-22730443.98744.10
20min1242673-24267346.96147.290.5747.1547.480.57
2245035-24503547.41847.61
3243460-24346047.11347.30
4244671-24467147.34847.54
5246537-24653747.70947.90
6243717-24371747.16347.35
30min1258517-25851750.02750.440.4950.3050.710.49
2261641-26164150.63250.90
3259824-25982450.28050.55
4261088-26108850.52550.80
5261856-26185650.67350.95
6260878-26087850.48450.74
45min1270155-27015552.27952.800.5652.6353.150.55
2273616-27361652.94953.30
3272101-27210152.65653.01
4273729-27372952.97153.33
5274279-27427953.07753.43
6273093-27309352.84853.19
60min1276871-27687153.57954.050.5454.0254.490.53
2280267-28026754.23654.68
3278569-27856953.90754.35
4280439-28043954.26954.71
5280790-28079054.33754.78
6278935-27893553.97854.41
极限1282225-28222554.61555.010.4655.1455.540.47
2284780-28478055.10955.64
3283724-28372454.90555.43
4285718-28571855.29155.83
5285419-28541955.23355.77
6283769-28376954.91455.44
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