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%
110.413273283276733273393270013274183273520.08
210.483294243295783295010.04
单位质量响应值RSD%判断
31445.9231440.940.02数据可信
供试品溶液-2024010612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%
5min1130357-13035737.16338.572.3437.1638.572.34
2139904-13990439.88439.88
3137162-13716239.10339.10
4134591-13459138.37038.37
5135151-13515138.52938.53
6134697-13469738.40038.40
10min1173554-17355449.47750.581.4349.5650.661.43
2180966-18096651.59051.68
3177312-17731250.54950.64
4179124-17912451.06551.15
5176249-17624950.24650.33
6177240-17724050.52850.61
15min1195909-19590955.85056.861.1856.0457.061.18
2200952-20095257.28857.49
3198661-19866156.63556.83
4202518-20251857.73557.93
5198174-19817456.49656.69
6200499-20049957.15957.36
20min1210359-21035959.97060.771.0260.2961.101.01
2214577-21457761.17261.50
3212459-21245960.56960.89
4216229-21622961.64361.97
5211474-21147460.28860.61
6213937-21393760.99061.31
30min1228300-22830065.08565.710.9765.5366.180.97
2231153-23115365.89866.36
3229250-22925065.35565.82
4234007-23400766.71267.18
5228559-22855965.15865.62
6231795-23179566.08166.54
45min1242963-24296369.26569.790.8569.8670.390.84
2244967-24496769.83670.45
3244317-24431769.65170.26
4248428-24842870.82371.43
5242779-24277969.21269.81
6245338-24533869.94270.55
60min1251316-25131671.64672.140.8172.3972.900.81
2253030-25303072.13572.90
3252576-25257672.00572.76
4256769-25676973.20173.97
5251189-25118971.61072.37
6253369-25336972.23172.99
极限1257150-25715073.30973.820.8474.2274.740.84
2258575-25857573.71574.64
3257743-25774373.47874.40
4262757-26275774.90875.84
5257279-25727973.34674.26
6260158-26015874.16775.09
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%
110.413288263288563288353291013290183289270.04
210.483302913305103304000.05
单位质量响应值RSD%判断
31597.2131526.720.16数据可信
供试品溶液-2024010612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%
5min1124105-12410535.24737.705.1835.2537.705.18
2134612-13461238.23238.23
3144838-14483841.13641.14
4131974-13197437.48237.48
5130033-13003336.93136.93
6130866-13086637.16837.17
10min1166847-16684747.38749.982.7847.4750.072.77
2179668-17966851.02851.11
3174134-17413449.45649.55
4178055-17805550.57050.65
5178948-17894850.82450.91
6178318-17831850.64550.73
15min1191523-19152354.39556.452.5354.5856.652.53
2203651-20365157.84058.04
3193373-19337354.92055.12
4201816-20181657.31857.51
5201415-20141557.20457.40
6200825-20082557.03757.23
20min1208281-20828159.15560.871.6159.4661.191.61
2217405-21740561.74662.07
3212337-21233760.30660.63
4216645-21664561.53061.85
5215405-21540561.17861.50
6215849-21584961.30461.63
30min1228709-22870964.95665.641.7665.3966.091.75
2234562-23456266.61967.08
3223968-22396863.61064.07
4233947-23394766.44466.90
5232846-23284666.13166.59
6232628-23262866.06966.53
45min1244179-24417969.35069.820.8069.9370.420.80
2248367-24836770.53971.15
3243184-24318469.06769.67
4247474-24747470.28670.89
5245984-24598469.86370.47
6245849-24584969.82470.43
60min1251414-25141471.40572.001.1672.1472.761.16
2256210-25621072.76773.54
3249052-24905270.73471.49
4256825-25682572.94273.71
5253494-25349471.99672.76
6254086-25408672.16472.92
极限1259112-25911273.59173.750.9474.4874.660.94
2261791-26179174.35275.28
3255338-25533872.51973.43
4262035-26203574.42175.35
5259889-25988973.81274.73
6259774-25977473.77974.70
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%
110.413294233290303287113275973284233286370.21
210.483287483286823287150.02
单位质量响应值RSD%判断
31569.3631365.940.46数据可信
供试品溶液-JPS6768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%
5min1169506-16950648.28747.931.4148.2947.931.41
2172392-17239249.10949.11
3166558-16655847.44747.45
4166032-16603247.29747.30
5167949-16794947.84347.84
6167070-16707047.59347.59
10min1205273-20527358.47658.640.4758.5858.740.47
2207613-20761359.14259.25
3204772-20477258.33358.44
4205869-20586958.64558.75
5205913-20591358.65858.76
6205596-20559658.56858.67
15min1222276-22227663.31963.380.3963.5663.620.39
2224024-22402463.81764.06
3221446-22144663.08363.32
4222750-22275063.45463.69
5222176-22217663.29163.53
6222362-22236263.34463.58
20min1232585-23258566.25666.190.3866.6366.560.38
2233708-23370866.57666.96
3231706-23170666.00566.38
4232909-23290966.34866.72
5231433-23143365.92866.30
6231747-23174766.01766.39
30min1246187-24618770.13170.120.4270.6670.640.42
2247091-24709170.38870.92
3245647-24564769.97770.50
4247516-24751670.50971.03
5244727-24472769.71570.24
6245642-24564269.97570.50
45min1254378-25437872.46472.770.3173.1473.450.32
2256651-25665173.11173.80
3254937-25493772.62373.30
4255628-25562872.82073.50
5255876-25587672.89173.57
6255306-25530672.72873.41
60min1260743-26074374.27774.330.3375.1275.180.33
2262255-26225574.70875.56
3260122-26012274.10074.94
4261664-26166474.53975.38
5260273-26027374.14374.98
6260591-26059174.23475.07
极限1263616-26361675.09575.090.2076.1076.100.20
2264390-26439075.31676.33
3263006-26300674.92275.93
4263899-26389975.17676.18
5263506-26350675.06476.07
6263133-26313374.95875.96
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%
110.413276173280113281083279603280243279440.06
210.483312833317353315090.10
单位质量响应值RSD%判断
31502.7931632.540.30数据可信
供试品溶液-JPS6768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%
5min1170666-17066648.46347.951.7548.4647.951.75
2172546-17254648.99749.00
3169176-16917648.04048.04
4169779-16977948.21148.21
5164246-16424646.64046.64
6166794-16679447.36347.36
10min1207003-20700358.78158.720.6858.8958.820.68
2207438-20743858.90559.01
3207403-20740358.89559.00
4208447-20844759.19159.30
5204528-20452858.07858.18
6205841-20584158.45158.56
15min1222833-22283363.27663.290.3763.5163.530.37
2223227-22322763.38863.63
3223232-22323263.39063.63
4223974-22397463.60063.84
5221599-22159962.92663.16
6222395-22239563.15263.39
20min1232387-23238765.98966.210.5666.3766.590.56
2231288-23128865.67766.06
3234025-23402566.45466.83
4234995-23499566.73067.11
5232777-23277766.10066.47
6233525-23352566.31266.69
30min1242901-24290168.97569.600.7369.5070.130.73
2243855-24385569.24669.77
3245635-24563569.75170.28
4248050-24805070.43770.97
5244665-24466569.47670.00
6245589-24558969.73870.26
45min1252644-25264471.74172.380.6872.4273.060.67
2253166-25316671.89072.57
3254557-25455772.28572.97
4256845-25684572.93473.62
5255937-25593772.67773.35
6256154-25615472.73873.42
60min1260245-26024573.90073.950.2374.7474.790.23
2260033-26003373.84074.68
3259948-25994873.81674.66
4261572-26157274.27775.12
5260228-26022873.89574.73
6260576-26057673.99474.83
极限1262312-26231274.48774.800.4475.4975.800.44
2262068-26206874.41875.42
3262901-26290174.65475.66
4264930-26493075.23076.24
5264360-26436075.06876.07
6263850-26385074.92475.93
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