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400
标示量(mg)30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%
112.339939339936939939849934399920919934280.08
212.319928649937189932910.07
单位质量响应值RSD%判断
80569.9980689.760.11数据可信
供试品溶液-2024010911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%
5min1207719-20771919.24418.532.5919.2418.532.58
2192242-19224217.81017.81
3199881-19988118.51818.52
4199466-19946618.48018.48
5197843-19784318.32918.33
6202964-20296418.80418.80
10min1245376-24537622.73322.530.8122.7722.560.82
2241812-24181222.40322.43
3241441-24144122.36822.40
4244667-24466722.66722.70
5240962-24096222.32422.35
6244688-24468822.66922.70
15min1263302-26330224.39424.340.3124.4624.410.32
2262217-26221724.29324.36
3261810-26181024.25624.32
4263321-26332124.39624.46
5262124-26212424.28524.35
6263810-26381024.44124.51
20min1273462-27346225.33525.300.1625.4525.410.18
2272721-27272125.26625.37
3272986-27298625.29125.40
4272559-27255925.25125.36
5273074-27307425.29925.41
6273684-27368425.35625.47
30min1282358-28235826.15926.180.3026.3126.330.30
2282298-28229826.15426.30
3283609-28360926.27526.43
4281268-28126826.05826.21
5282771-28277126.19726.35
6283352-28335226.25126.40
45min1290165-29016526.88326.870.3627.0827.070.35
2289881-28988126.85627.05
3291323-29132326.99027.18
4288268-28826826.70726.90
5290678-29067826.93027.12
6290172-29017226.88327.08
60min1292067-29206727.05927.130.4727.3027.370.47
2292594-29259427.10827.35
3294717-29471727.30427.54
4290714-29071426.93327.17
5293295-29329527.17227.41
6293439-29343927.18627.43
极限1296273-29627327.44827.300.4227.7327.580.42
2293446-29344627.18627.47
3295646-29564627.39027.68
4293153-29315327.15927.44
5295065-29506527.33627.62
6294345-29434527.27027.56
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400
标示量(mg)30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%
112.339929019926359918549921889925069924170.05
212.319932589931219931900.01
单位质量响应值RSD%判断
80488.0080681.560.17数据可信
供试品溶液-2024010911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%
5min1209815-20981519.44918.962.2419.4518.962.24
2204069-20406918.91718.92
3205467-20546719.04619.05
4199031-19903118.45018.45
5209111-20911119.38419.38
6199574-19957418.50018.50
10min1247068-24706822.90322.701.1322.9422.731.13
2242174-24217422.44922.48
3245965-24596522.80022.83
4242012-24201222.43422.46
5248623-24862323.04723.08
6243436-24343622.56622.60
15min1264285-26428524.49924.340.8024.5724.410.80
2261624-26162424.25224.32
3263140-26314024.39224.46
4259330-25933024.03924.11
5265158-26515824.57924.65
6261826-26182624.27124.34
20min1272281-27228125.24025.230.6325.3525.340.64
2272109-27210925.22425.33
3273433-27343325.34725.46
4269657-26965724.99725.10
5274422-27442225.43825.55
6270911-27091125.11325.22
30min1281006-28100626.04926.080.4026.2026.230.41
2282152-28215226.15526.31
3282352-28235226.17326.33
4279308-27930825.89126.04
5281823-28182326.12426.28
6281193-28119326.06626.22
45min1288236-28823626.71926.780.4326.9226.980.43
2290207-29020726.90127.10
3290004-29000426.88327.08
4287092-28709226.61326.81
5289559-28955926.84127.04
6288237-28823726.71926.91
60min1291469-29146927.01827.080.3327.2627.320.33
2292734-29273427.13627.38
3293438-29343827.20127.44
4290778-29077826.95427.19
5292443-29244327.10927.35
6291969-29196927.06527.30
极限1293371-29337127.19527.190.3627.4827.480.37
2293696-29369627.22527.51
3294510-29451027.30027.59
4291465-29146527.01827.30
5293974-29397427.25127.54
6293183-29318327.17727.46
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400
标示量(mg)30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%
112.339938229930029940809933529935699935650.05
212.311008135100783610079860.03
单位质量响应值RSD%判断
80581.1081883.511.14数据可信
供试品溶液-2024010612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%
5min1222837-22283720.49320.431.6920.4920.431.69
2220750-22075020.30120.30
3228956-22895621.05621.06
4217784-21778420.02820.03
5220828-22082820.30820.31
6221758-22175820.39420.39
10min1258453-25845323.76823.780.5923.8023.820.58
2258538-25853823.77623.81
3260781-26078123.98324.02
4258572-25857223.77923.81
5259036-25903623.82223.86
6256100-25610023.55223.59
15min1274831-27483125.27525.320.6225.3525.390.62
2276982-27698225.47225.55
3275695-27569525.35425.43
4275972-27597225.38025.45
5276024-27602425.38425.46
6272127-27212725.02625.10
20min1283838-28383826.10326.130.6726.2226.250.67
2285585-28558526.26426.38
3284084-28408426.12626.24
4286462-28646226.34426.46
5283922-28392226.11126.23
6280905-28090525.83325.95
30min1292549-29254926.90426.960.5627.0627.120.57
2294871-29487127.11827.28
3293464-29346426.98827.15
4293577-29357726.99927.16
5294124-29412427.04927.21
6290187-29018726.68726.84
45min1299567-29956727.54927.550.4827.7527.750.48
2300607-30060727.64527.85
3299599-29959927.55227.76
4299853-29985327.57627.78
5300713-30071327.65527.86
6296837-29683727.29827.50
60min1302511-30251127.82027.820.4028.0728.070.41
2303204-30320427.88428.13
3302762-30276227.84328.10
4302757-30275727.84328.09
5303538-30353827.91528.17
6300145-30014527.60327.85
极限1303518-30351827.91327.940.4728.2128.230.46
2304846-30484628.03528.33
3304794-30479428.03028.33
4303896-30389627.94828.24
5304488-30448828.00228.30
6301130-30113027.69327.99
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400
标示量(mg)30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%
112.339939759943719941549935029928329937670.07
212.311002504100301010027570.04
单位质量响应值RSD%判断
80597.4981458.730.76数据可信
供试品溶液-2024010612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%
5min1212745-21274519.61418.932.1719.6118.932.17
2205968-20596818.98918.99
3200283-20028318.46518.46
4203091-20309118.72418.72
5202407-20240718.66018.66
6207429-20742919.12319.12
10min1256199-25619923.62023.460.7123.6523.480.71
2256432-25643223.64123.67
3252723-25272323.29923.33
4253205-25320523.34423.37
5252526-25252623.28123.31
6255430-25543023.54923.58
15min1273767-27376725.23925.130.5725.3125.200.57
2273757-27375725.23825.31
3273567-27356725.22125.29
4272005-27200525.07725.15
5269775-26977524.87124.94
6272873-27287325.15725.23
20min1281352-28135225.93925.940.6626.0526.050.67
2281260-28126025.93026.04
3282955-28295526.08626.20
4281649-28164925.96626.08
5277904-27790425.62125.73
6282931-28293126.08426.20
30min1289076-28907626.65126.710.7926.8126.870.79
2289937-28993726.73026.89
3292768-29276826.99127.15
4289915-28991526.72826.88
5285859-28585926.35426.51
6290683-29068326.79926.96
45min1294670-29467027.16627.240.8227.3727.440.82
2295518-29551827.24527.45
3299666-29966627.62727.83
4295532-29553227.24627.45
5292241-29224126.94327.14
6295003-29500327.19727.40
60min1297709-29770927.44727.510.8327.6927.760.82
2298136-29813627.48627.73
3302896-30289627.92528.17
4298375-29837527.50827.75
5295346-29534627.22927.47
6298136-29813627.48627.73
极限1299393-29939327.60227.640.7227.8927.930.71
2299851-29985127.64427.94
3303486-30348627.97928.27
4299000-29900027.56627.86
5296854-29685427.36827.66
6299955-29995527.65427.95
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