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%
112.339756389750849750119748489748279750820.04
212.319747309746779747040.01
单位质量响应值RSD%判断
79082.0879179.850.09数据可信
供试品溶液-2024010511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%
5min1264913-26491325.00823.882.4125.0123.882.42
2250243-25024323.62323.62
3252535-25253523.83923.84
4251361-25136123.72923.73
5251376-25137623.73023.73
6247492-24749223.36323.36
10min1301727-30172728.48327.811.3328.5227.851.32
2293509-29350927.70727.75
3294908-29490827.83927.88
4294793-29479327.82927.87
5290432-29043227.41727.46
6291913-29191327.55727.60
15min1317057-31705729.93029.450.9330.0229.540.94
2310682-31068229.32929.41
3312498-31249829.50029.59
4312492-31249229.49929.59
5308535-30853529.12629.21
6310551-31055129.31629.40
20min1325406-32540630.71830.240.9930.8630.380.99
2319011-31901130.11530.25
3321374-32137430.33830.47
4321662-32166230.36530.50
5316241-31624129.85329.99
6318637-31863730.07930.21
30min1333079-33307931.44331.090.6931.6331.280.69
2328739-32873931.03331.22
3329655-32965531.12031.31
4330549-33054931.20431.39
5327340-32734030.90131.08
6326994-32699430.86831.05
45min1339288-33928832.02931.670.7832.2731.900.79
2335468-33546831.66831.90
3337131-33713131.82532.06
4335557-33555731.67731.91
5333334-33333431.46731.70
6331970-33197031.33831.57
60min1341560-34156032.24331.910.6732.5432.200.67
2338538-33853831.95832.25
3339195-33919532.02032.31
4337607-33760731.87032.16
5336502-33650231.76632.05
6335061-33506131.63031.92
极限1342742-34274232.35532.000.6932.7032.340.69
2339435-33943532.04332.39
3340244-34024432.11932.46
4338020-33802031.90932.25
5337476-33747631.85832.20
6336126-33612631.73032.07
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%
112.339705429704439700829712069710169706580.05
212.319715049709919712480.04
单位质量响应值RSD%判断
78723.2878899.110.16数据可信
供试品溶液-2024010511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%
5min1263597-26359724.98523.936.7024.9823.926.70
2259990-25999024.64324.64
3257841-25784124.43924.44
4256207-25620724.28424.28
5258693-25869324.52024.52
6218312-21831220.69220.69
10min1298341-29834128.27828.013.8228.3228.053.82
2299151-29915128.35528.40
3304734-30473428.88428.92
4296676-29667628.12028.16
5301049-30104928.53528.58
6273236-27323625.89825.93
15min1312677-31267729.63729.542.0529.7329.632.06
2315030-31503029.86029.95
3314148-31414829.77629.86
4313069-31306929.67429.76
5316149-31614929.96630.05
6298906-29890628.33128.41
20min1320134-32013430.34330.341.2130.4830.481.21
2322329-32232930.55230.69
3322627-32262730.58030.72
4320463-32046330.37530.51
5322683-32268330.58530.72
6312613-31261329.63129.76
30min1328171-32817131.10531.200.4731.2931.380.48
2329273-32927331.21031.40
3331605-33160531.43131.62
4329164-32916431.19931.39
5329556-32955631.23731.43
6327061-32706131.00031.17
45min1333438-33343831.60431.800.5331.8532.040.53
2336015-33601531.84932.09
3338278-33827832.06332.31
4334286-33428631.68531.92
5334612-33461231.71631.96
6336652-33665231.90932.14
60min1336496-33649631.89432.040.6332.1932.330.60
2338033-33803332.04032.33
3340632-34063232.28632.58
4336613-33661331.90532.20
5335934-33593431.84132.14
6340623-34062332.28532.56
极限1337701-33770132.00932.120.5732.3532.470.57
2339215-33921532.15232.50
3341901-34190132.40732.76
4337373-33737331.97732.32
5336967-33696731.93932.29
6340319-34031932.25732.59
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%
112.339715899724889726119723299730959724220.06
212.319781929783529782720.02
单位质量响应值RSD%判断
78866.3479469.700.54数据可信
供试品溶液-2024010611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%
5min1249675-24967523.55923.101.6823.5623.101.67
2239150-23915022.56622.57
3241301-24130122.76922.77
4244622-24462223.08223.08
5248736-24873623.47023.47
6245458-24545823.16123.16
10min1287663-28766327.14326.701.0727.1826.741.06
2278887-27888726.31526.35
3280816-28081626.49726.54
4284228-28422826.81926.86
5283333-28333326.73526.77
6283034-28303426.70626.75
15min1304068-30406828.69128.260.8228.7828.350.82
2297691-29769128.08928.17
3297880-29788028.10728.19
4300248-30024828.33128.41
5297944-29794428.11328.20
6299485-29948528.25928.34
20min1312491-31249129.48629.050.7829.6229.180.78
2307369-30736929.00329.13
3306830-30683028.95229.08
4307948-30794829.05729.19
5305664-30566428.84228.97
6306954-30695428.96329.09
30min1319096-31909630.10929.860.5330.2930.040.52
2317073-31707329.91830.09
3316509-31650929.86530.04
4316030-31603029.82030.00
5315994-31599429.81630.00
6314015-31401529.63029.81
45min1324929-32492930.66030.360.7530.8930.580.75
2323397-32339730.51530.74
3321683-32168330.35330.58
4322320-32232030.41330.64
5318744-31874430.07630.30
6319143-31914330.11430.34
60min1326523-32652330.81030.570.5531.0930.840.55
2324913-32491330.65830.94
3324055-32405530.57730.85
4324019-32401930.57430.85
5322605-32260530.44030.72
6321476-32147630.33430.61
极限1326937-32693730.84930.610.5831.1830.940.57
2325931-32593130.75431.08
3324511-32451130.62030.95
4324250-32425030.59530.93
5322326-32232630.41430.74
6322373-32237330.41830.75
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%
112.339752339759899761009756359762339758380.05
212.319768489767069767770.02
单位质量响应值RSD%判断
79143.3979348.250.19数据可信
供试品溶液-2024010611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%
5min1243572-24357222.96023.062.3222.9623.062.32
2242246-24224622.83522.84
3251158-25115823.67523.68
4239205-23920522.54822.55
5239677-23967722.59322.59
6252193-25219323.77323.77
10min1281672-28167226.55126.561.3326.5926.601.32
2281263-28126326.51326.55
3286446-28644627.00127.04
4277924-27792426.19826.24
5277605-27760526.16826.21
6285680-28568026.92926.97
15min1297199-29719928.01528.030.9028.1028.110.91
2297662-29766228.05928.14
3301642-30164228.43428.52
4295876-29587627.89027.97
5293534-29353427.67027.75
6298013-29801328.09228.18
20min1306198-30619828.86328.910.7028.9929.040.71
2305517-30551728.79928.93
3310877-31087729.30429.44
4305774-30577428.82328.95
5306821-30682128.92229.05
6305029-30502928.75328.88
30min1315836-31583629.77229.670.9929.9529.840.99
2313054-31305429.51029.69
3320160-32016030.17930.36
4315057-31505729.69829.87
5311290-31129029.34329.52
6312982-31298229.50329.68
45min1321790-32179030.33330.250.9630.5630.480.95
2318696-31869630.04130.27
3325932-32593230.72430.95
4322305-32230530.38230.61
5317745-31774529.95230.18
6318858-31885830.05730.29
60min1324531-32453130.59230.430.9330.8730.710.93
2320729-32072930.23330.51
3327491-32749130.87131.15
4323797-32379730.52230.80
5319473-31947330.11530.39
6320960-32096030.25530.53
极限1325117-32511730.64730.540.9230.9830.860.92
2321796-32179630.33430.66
3328398-32839830.95631.29
4325289-32528930.66330.99
5319981-31998130.16330.49
6323050-32305030.45230.78
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