利伐沙班颗粒项目信息
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%
112.134789894789084789144790834788764789540.02
212.074776234776684776460.01
单位质量响应值RSD%判断
39485.0839572.990.16数据可信
加速6月-供试品溶液-2024010711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%
5min1173778-17377832.84031.864.3732.8431.864.37
2170703-17070332.25932.26
3175055-17505533.08133.08
4156341-15634129.54529.54
5172727-17272732.64132.64
6163094-16309430.82130.82
10min1217418-21741841.08741.211.7341.1641.281.73
2218275-21827541.24941.32
3222488-22248842.04542.12
4212272-21227240.11440.18
5221723-22172341.90041.97
6216147-21614740.84640.91
15min1238120-23812044.99945.131.3045.1645.291.30
2237152-23715244.81644.98
3242945-24294545.91146.08
4234762-23476244.36444.52
5241958-24195845.72445.89
6237901-23790144.95745.12
20min1250253-25025347.29247.421.0447.5647.681.04
2249281-24928147.10847.37
3254646-25464648.12248.39
4248035-24803546.87247.13
5253546-25354647.91448.18
6249796-24979647.20547.46
30min1264144-26414449.91749.990.8450.2950.360.84
2261721-26172149.45949.83
3267471-26747150.54550.92
4262832-26283249.66950.03
5266696-26669650.39950.77
6264337-26433749.95350.32
45min1274206-27420651.81851.850.6752.3052.330.68
2271708-27170851.34651.82
3276901-27690152.32752.82
4273512-27351251.68752.15
5275936-27593652.14552.63
6273999-27399951.77952.25
60min1279889-27988952.89252.780.6053.4953.380.60
2276652-27665252.28052.87
3281484-28148453.19453.80
4278620-27862052.65253.24
5280236-28023652.95853.56
6278892-27889252.70453.29
极限1283102-28310253.49953.480.6054.2154.190.61
2280046-28004652.92253.63
3284547-28454753.77254.50
4282612-28261253.40754.11
5284724-28472453.80654.53
6282980-28298053.47654.18
利伐沙班颗粒项目信息
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%
112.134769984770304769994761414751594764650.18
212.074763224764784764000.03
单位质量响应值RSD%判断
39279.8839469.760.35数据可信
加速6月-供试品溶液-2024010811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%
5min1188553-18855335.77233.204.4535.7733.204.45
2173782-17378232.96932.97
3170550-17055032.35632.36
4166100-16610031.51231.51
5178480-17848033.86133.86
6172428-17242832.71232.71
10min1230997-23099743.82442.371.9443.9042.441.94
2221210-22121041.96742.04
3222178-22217842.15142.22
4218822-21882241.51441.58
5225396-22539642.76142.84
6221377-22137741.99942.07
15min1249119-24911947.26246.431.0047.4446.601.01
2241865-24186545.88646.05
3245149-24514946.50946.67
4243672-24367246.22946.39
5244810-24481046.44446.61
6243843-24384346.26146.43
20min1260164-26016449.35748.730.8149.6449.000.81
2253946-25394648.17848.45
3257804-25780448.91049.18
4256192-25619248.60448.87
5256768-25676848.71348.99
6256238-25623848.61348.88
30min1271894-27189451.58351.230.5551.9751.610.56
2267445-26744550.73951.11
3270857-27085751.38651.76
4270178-27017851.25751.63
5270181-27018151.25851.64
6269794-26979451.18451.56
45min1280000-28000053.12152.960.4853.6353.450.48
2276913-27691352.53553.02
3280281-28028153.17453.67
4280200-28020053.15853.65
5279051-27905152.94153.44
6278369-27836952.81153.30
60min1284533-28453353.98153.820.4054.6054.440.40
2281773-28177353.45754.06
3284618-28461853.99754.61
4284561-28456153.98654.59
5283611-28361153.80654.42
6283167-28316753.72154.33
极限1287063-28706354.46154.470.3955.2055.200.38
2285377-28537754.14154.86
3287752-28775254.59155.32
4288423-28842354.71955.44
5286336-28633654.32355.06
6287644-28764454.57155.30
利伐沙班颗粒项目信息
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%
112.134769354773294770104768244767594769710.05
212.074768904768974768940.01
单位质量响应值RSD%判断
39321.6039510.690.34数据可信
加速6月-供试品溶液-2024010911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%
5min1166852-16685231.62132.824.5231.6232.824.51
2160234-16023430.36730.37
3179296-17929633.98033.98
4176671-17667133.48233.48
5178884-17888433.90233.90
6177120-17712033.56733.57
10min1217158-21715841.15542.072.4441.2342.142.44
2213309-21330940.42640.49
3225648-22564842.76442.84
4224760-22476042.59642.67
5226252-22625242.87942.95
6224758-22475842.59642.67
15min1239839-23983945.45446.281.6945.6246.441.70
2238219-23821945.14745.30
3246212-24621246.66146.83
4246032-24603246.62746.80
5248435-24843547.08347.25
6246343-24634346.68646.86
20min1253948-25394848.12848.641.0948.3948.911.10
2252566-25256647.86648.12
3258394-25839448.97049.24
4257070-25707048.71948.99
5259360-25936049.15349.43
6258648-25864849.01849.29
30min1267570-26757050.70951.230.7951.0851.600.80
2267739-26773950.74151.11
3271665-27166551.48551.87
4271235-27123551.40451.78
5272556-27255651.65452.04
6271021-27102151.36351.75
45min1277537-27753752.59853.060.6153.0853.540.61
2278381-27838152.75853.23
3280424-28042453.14553.64
4280679-28067953.19453.69
5282107-28210753.46453.96
6280600-28060053.17953.67
60min1282730-28273053.58253.920.5654.1854.530.57
2282920-28292053.61854.21
3285773-28577354.15954.77
4284992-28499254.01154.62
5286626-28662654.32154.94
6284030-28403053.82954.44
极限1286615-28661554.31954.570.4055.0455.300.42
2286673-28667354.33055.04
3288562-28856254.68855.42
4287902-28790254.56255.30
5289528-28952854.87155.61
6288519-28851954.67955.41
利伐沙班颗粒项目信息
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%
112.134772324767484768384765394765134767740.07
212.074770104768824769460.02
单位质量响应值RSD%判断
39305.3639515.000.38数据可信
长期6月-供试品溶液-2024010711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%
5min1160219-16021930.36931.162.6630.3731.162.66
2161152-16115230.54630.55
3168619-16861931.96131.96
4161616-16161630.63430.63
5170844-17084432.38332.38
6163769-16376931.04231.04
10min1210168-21016839.83740.511.1439.9040.581.15
2213989-21398940.56140.63
3216865-21686541.10641.18
4211849-21184940.15540.22
5215545-21554540.85640.93
6213803-21380340.52640.59
15min1232431-23243144.05644.780.9044.2144.940.90
2237653-23765345.04645.20
3237780-23778045.07045.23
4235126-23512644.56744.72
5237552-23755245.02745.19
6236990-23699044.92145.08
20min1246168-24616846.66047.190.6746.9147.450.67
2251250-25125047.62447.88
3249552-24955247.30247.56
4248800-24880047.15947.42
5249194-24919447.23447.50
6248757-24875747.15147.41
30min1262893-26289349.83050.050.4450.1950.420.44
2265852-26585250.39150.76
3262973-26297349.84650.21
4264415-26441550.11950.48
5263487-26348749.94350.31
6264741-26474150.18150.54
45min1272179-27217951.59151.900.5152.0652.370.51
2275403-27540352.20252.68
3272559-27255951.66352.14
4275354-27535452.19252.66
5273148-27314851.77452.25
6274200-27420051.97452.45
60min1278533-27853352.79552.970.4353.3853.560.42
2280277-28027753.12553.72
3277763-27776352.64953.24
4280485-28048553.16553.75
5278969-27896952.87853.47
6280613-28061353.18953.78
极限1282744-28274453.59353.710.5154.2954.420.50
2284553-28455353.93654.65
3281013-28101353.26553.98
4284414-28441453.91054.62
5284584-28458453.94254.65
6282892-28289253.62154.33
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