利伐沙班颗粒片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.203239313237433236633239113240403238580.05
210.353237813239793238800.05
单位质量响应值RSD%判断
31750.7831292.751.03数据可信
供试品溶液-2023073011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%
5min1124420-12442035.38432.668.0235.3832.668.02
2122177-12217734.74634.75
3123067-12306734.99935.00
4106355-10635530.24630.25
5105840-10584030.10030.10
6107237-10723730.49730.50
10min1164423-16442346.76045.372.9346.8445.442.94
2163245-16324546.42546.50
3163357-16335746.45746.53
4154740-15474044.00644.07
5154223-15422343.85943.93
6157185-15718544.70244.77
15min1184871-18487152.57551.981.1052.7652.151.11
2184056-18405652.34452.52
3184560-18456052.48752.67
4180662-18066251.37851.54
5180370-18037051.29551.46
6182083-18208351.78351.95
20min1198288-19828856.39156.270.2656.6956.560.27
2198296-19829656.39356.69
3198031-19803156.31856.62
4197145-19714556.06656.35
5197296-19729656.10956.39
6198063-19806356.32756.61
30min1215790-21579061.36861.480.4161.7961.900.39
2215530-21553061.29561.72
3215034-21503461.15461.58
4216834-21683461.66562.07
5216673-21667361.62062.02
6217284-21728461.79362.20
45min1230820-23082065.64365.750.6166.2066.300.59
2229500-22950065.26765.83
3229796-22979665.35265.91
4231674-23167465.88666.43
5232753-23275366.19366.73
6232669-23266966.16966.71
60min1239139-23913968.00968.390.5568.7269.090.53
2239651-23965168.15468.86
3239091-23909167.99568.70
4241659-24165968.72569.41
5241439-24143968.66369.35
6241879-24187968.78869.48
极限1248904-24890470.78670.900.4271.6471.740.41
2248423-24842370.64971.50
3247935-24793570.51071.37
4249964-24996471.08771.93
5249898-24989871.06871.91
6250627-25062771.27672.12
利伐沙班颗粒片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.203243873242973239383239613238163240800.08
210.353245373243393244380.05
单位质量响应值RSD%判断
31772.5531346.670.96数据可信
供试品溶液-2023073011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%
5min1122134-12213434.69234.382.3334.6934.382.33
2123717-12371735.14135.14
3123141-12314134.97834.98
4119335-11933533.89733.90
5121632-12163234.54934.55
6116187-11618733.00333.00
10min1162452-16245246.14446.130.6546.2246.200.65
2164249-16424946.65446.73
3162773-16277346.23546.31
4161890-16189045.98446.06
5161621-16162145.90845.98
6161377-16137745.83945.91
15min1179360-17936050.94752.041.1551.1352.221.14
2183778-18377852.20252.38
3183814-18381452.21252.39
4184084-18408452.28852.47
5182742-18274251.90752.09
6185568-18556852.71052.89
20min1198125-19812556.27756.230.6356.5756.530.62
2197401-19740156.07156.37
3197082-19708255.98156.28
4198241-19824156.31056.60
5196787-19678755.89756.19
6200193-20019356.86457.16
30min1214837-21483761.02461.500.6961.4461.920.69
2216280-21628061.43461.86
3217208-21720861.69762.12
4216467-21646761.48761.91
5215225-21522561.13461.55
6218972-21897262.19862.62
45min1229660-22966065.23465.830.9165.7966.390.91
2230129-23012965.36765.93
3234325-23432566.55967.12
4233526-23352666.33266.89
5229850-22985065.28865.84
6233055-23305566.19966.76
60min1238669-23866967.79368.390.8068.4969.100.79
2239592-23959268.05568.76
3243851-24385169.26569.97
4241535-24153568.60769.31
5239469-23946968.02068.72
6241556-24155668.61369.32
极限1246507-24650770.02070.790.8370.8771.640.82
2247820-24782070.39271.25
3252213-25221371.64072.50
4250625-25062571.18972.04
5248479-24847970.58071.43
6249687-24968770.92371.78
利伐沙班颗粒片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.203232893235553233793234883235283234480.04
210.353225613226723226160.03
单位质量响应值RSD%判断
31710.5931170.631.22数据可信
供试品溶液-JPS5249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%
5min1136048-13604838.79140.568.1238.7940.568.12
2128160-12816036.54236.54
3132012-13201237.64137.64
4149538-14953842.63842.64
5153812-15381243.85643.86
6153956-15395643.89743.90
10min1186115-18611553.06752.663.1853.1552.753.19
2177991-17799150.75150.83
3181838-18183851.84751.93
4188087-18808753.62953.72
5180131-18013151.36151.46
6193906-19390655.28855.39
15min1207956-20795659.29459.221.8959.5059.421.91
2201736-20173657.52157.71
3206002-20600258.73758.94
4210085-21008559.90260.12
5206967-20696759.01359.22
6213359-21335960.83561.06
20min1220917-22091762.99063.151.6463.3363.491.65
2216933-21693361.85462.18
3218706-21870662.36062.69
4220909-22090962.98863.33
5226547-22654764.59564.94
6224826-22482664.10564.46
30min1236095-23609567.31867.360.6667.7967.840.67
2234376-23437666.82867.29
3235507-23550767.15067.62
4236601-23660167.46267.95
5235908-23590867.26467.75
6238986-23898668.14268.64
45min1250086-25008671.30771.451.8671.9372.081.86
2247695-24769570.62571.23
3249596-24959671.16771.78
4248005-24800570.71471.35
5248242-24824270.78171.42
6259871-25987174.09774.75
60min1256443-25644373.12072.880.4573.9073.660.45
2253965-25396572.41373.18
3256880-25688073.24474.02
4254786-25478672.64773.44
5255166-25516672.75573.55
6256291-25629173.07673.89
极限1260199-26019974.19174.300.2075.1475.250.21
2260520-26052074.28275.21
3260195-26019574.18975.13
4261291-26129174.50275.46
5260195-26019574.18975.14
6261112-26111274.45175.43
利伐沙班颗粒片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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%
110.203256573253213255903255533254943255230.04
210.353251783249093250440.06
单位质量响应值RSD%判断
31914.0231405.221.14数据可信
供试品溶液-JPS5249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%
5min1135177-13517738.27638.494.9738.2838.504.98
2122736-12273634.75334.75
3138018-13801839.08039.08
4140774-14077439.86139.86
5139098-13909839.38639.39
6139877-13987739.60739.61
10min1181771-18177151.46951.613.7851.5551.703.78
2169200-16920047.91047.99
3183198-18319851.87351.96
4186819-18681952.89952.99
5183977-18397752.09452.18
6188719-18871953.43753.52
15min1205676-20567658.23858.092.5758.4458.302.58
2194914-19491455.19155.37
3205860-20586058.29058.49
4208707-20870759.09659.30
5206369-20636958.43458.64
6209497-20949759.32059.53
20min1219741-21974162.22162.091.8262.5562.421.83
2211615-21161559.92060.23
3219773-21977362.23062.56
4222353-22235362.96063.30
5219790-21979062.23562.57
6222464-22246462.99263.33
30min1235521-23552166.68966.701.0367.1667.171.04
2230793-23079365.35065.79
3236276-23627666.90367.37
4237058-23705867.12467.60
5237094-23709467.13467.61
6236715-23671567.02767.51
45min1247575-24757570.10270.400.5870.7271.010.59
2246298-24629869.74170.33
3248643-24864370.40571.02
4249960-24996070.77771.40
5249751-24975170.71871.34
6249466-24946670.63871.27
60min1254434-25443472.04472.400.5972.8273.160.61
2253479-25347971.77472.51
3255582-25558272.36973.14
4257104-25710472.80073.58
5256139-25613972.52773.30
6257306-25730672.85773.64
极限1262076-26207674.20873.950.4375.1474.890.44
2259669-25966973.52774.43
3260625-26062573.79774.73
4260325-26032573.71274.66
5262010-26201074.18975.13
6262333-26233374.28175.23
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