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%
115.024767854767404771484770844773824770280.06
215.044819844816504818170.05
单位质量响应值RSD%判断
31759.5232035.700.62数据可信
供试品溶液-2024122821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%
5min1129296-12929624.22421.378.1624.2221.378.16
2120300-12030022.53922.54
3112847-11284721.14221.14
4104145-10414519.51219.51
5110832-11083220.76520.76
6106903-10690320.02920.03
10min1182833-18283334.25432.403.4534.2932.433.45
2177377-17737733.23233.27
3169865-16986531.82531.86
4170625-17062531.96732.00
5169935-16993531.83831.87
6166943-16694331.27731.31
15min1210186-21018639.37938.082.1639.4838.162.17
2206681-20668138.72238.82
3200189-20018937.50637.59
4202684-20268437.97338.06
5200983-20098337.65537.74
6198642-19864237.21637.30
20min1229121-22912142.92641.931.3743.0942.081.37
2225710-22571042.28742.44
3221704-22170441.53741.69
4222503-22250341.68741.84
5222712-22271241.72641.88
6221106-22110641.42541.57
30min1253708-25370847.53346.950.9147.7747.170.92
2252945-25294547.39047.62
3249955-24995546.83047.05
4250011-25001146.84047.06
5248639-24863946.58346.80
6248215-24821546.50446.72
45min1275201-27520151.56051.250.5651.8751.560.56
2275344-27534451.58751.89
3274093-27409351.35251.65
4272336-27233651.02351.32
5272584-27258451.06951.37
6271869-27186950.93551.23
60min1286764-28676453.72653.750.5254.1354.140.52
2288830-28883054.11354.51
3288551-28855154.06154.44
4285302-28530253.45253.83
5285912-28591253.56653.95
6286010-28601053.58553.96
极限1297876-29787655.80855.690.4956.3056.170.50
2298874-29887455.99556.48
3298508-29850855.92656.40
4296755-29675555.59856.07
5296386-29638655.52956.00
6295065-29506555.28155.75
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%
115.024772134764944767264769184772164769130.07
215.044786964784944785950.03
单位质量响应值RSD%判断
31751.8631821.480.16数据可信
供试品溶液-2024122821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%
5min1174918-17491832.88532.874.2732.8932.884.27
2176955-17695533.26833.27
3163196-16319630.68130.68
4185237-18523734.82534.83
5170620-17062032.07732.08
6178225-17822533.50733.51
10min1235049-23504944.19044.421.5144.2444.471.51
2235559-23555944.28644.34
3232745-23274543.75743.81
4242695-24269545.62845.69
5233964-23396443.98644.04
6237595-23759544.66944.72
15min1262997-26299749.44449.170.7349.5749.300.73
2260061-26006148.89249.02
3260132-26013248.90649.03
4264528-26452849.73249.87
5259892-25989248.86148.99
6261469-26146949.15749.29
20min1277741-27774152.21651.680.7552.4351.900.75
2273241-27324151.37051.58
3274790-27479051.66151.87
4277021-27702152.08152.30
5273713-27371351.45951.67
6272911-27291151.30851.52
30min1291785-29178554.85754.500.4655.1554.800.46
2288214-28821454.18554.48
3289989-28998954.51954.81
4290596-29059654.63354.94
5290165-29016554.55254.85
6288517-28851754.24254.54
45min1302792-30279256.92656.410.7657.3256.800.76
2297394-29739455.91156.30
3301165-30116556.62057.00
4301685-30168556.71857.11
5300009-30000956.40356.79
6297321-29732155.89756.29
60min1307150-30715057.74557.480.4558.2357.960.44
2304210-30421057.19357.67
3307237-30723757.76258.24
4305591-30559157.45257.94
5306067-30606757.54258.02
6304194-30419457.19057.67
极限1310698-31069858.41258.150.5558.9958.730.55
2307809-30780957.86958.44
3310925-31092558.45559.03
4309092-30909258.11058.70
5310421-31042158.36058.94
6306813-30681357.68258.26
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%
115.024801614802384804164803064799754802190.04
215.044851854845164848500.10
单位质量响应值RSD%判断
31971.9732237.370.59数据可信
供试品溶液-2024122821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%
5min1127112-12711223.66122.904.5823.6622.904.58
2119482-11948222.24122.24
3129049-12904924.02224.02
4123038-12303822.90322.90
5125616-12561623.38323.38
6113748-11374821.17421.17
10min1180363-18036333.57433.262.3233.6133.302.32
2176624-17662432.87832.91
3181727-18172733.82733.87
4179307-17930733.37733.42
5182733-18273334.01534.05
6171449-17144931.91431.95
15min1208918-20891838.88938.461.8638.9838.551.87
2204651-20465138.09538.19
3207959-20795938.71038.81
4207556-20755638.63538.73
5210651-21065139.21139.31
6199859-19985937.20337.29
20min1227426-22742642.33441.931.4842.4942.081.48
2224742-22474241.83441.99
3226016-22601642.07242.23
4226517-22651742.16542.32
5227849-22784942.41342.57
6218824-21882440.73340.88
30min1248758-24875846.30546.011.3046.5446.241.31
2248530-24853046.26246.49
3248061-24806146.17546.41
4247404-24740446.05346.28
5249586-24958646.45946.69
6240803-24080344.82445.04
45min1265610-26561049.44249.100.9249.7549.400.93
2264079-26407949.15749.46
3265357-26535749.39549.70
4264080-26408049.15749.46
5264431-26443149.22249.53
6258998-25899848.21148.50
60min1274435-27443551.08550.700.9351.4751.080.93
2272531-27253150.73051.11
3273669-27366950.94251.33
4273038-27303850.82451.21
5273172-27317250.84951.24
6267397-26739749.77450.15
极限1279973-27997352.11551.870.7052.5952.340.70
2279155-27915551.96352.43
3280079-28007952.13552.61
4279814-27981452.08652.56
5277784-27778451.70852.18
6275114-27511451.21151.67
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