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)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%
110.323237503240923238313240323240633239540.05
210.243250673240213245440.23
单位质量响应值RSD%判断
31390.8931693.750.68数据可信
供试品溶液-2024122521批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1196843-19684355.94257.742.5755.9457.742.57
2197226-19722656.05156.05
3208123-20812359.14859.15
4205966-20596658.53558.53
5208415-20841559.23159.23
6202380-20238057.51657.52
10min1258698-25869873.52174.731.7873.6174.821.78
2257662-25766273.22773.32
3266902-26690275.85375.95
4269127-26912776.48576.58
5264750-26475075.24175.34
6260529-26052974.04174.14
15min1279030-27903079.29980.111.1279.5280.331.13
2277521-27752178.87079.09
3284945-28494580.98081.21
4285479-28547981.13281.36
5282382-28238280.25280.48
6281869-28186980.10680.33
20min1290064-29006482.43583.010.7382.7883.370.74
2289131-28913182.17082.52
3293944-29394483.53883.90
4294503-29450383.69784.06
5292709-29270983.18783.54
6292217-29221783.04783.40
30min1299518-29951885.12286.131.0985.6186.621.09
2299169-29916985.02385.51
3304056-30405686.41286.91
4307976-30797687.52688.03
5303990-30399086.39386.89
6303702-30370286.31186.80
45min1306927-30692787.22787.980.8987.8588.610.89
2305445-30544586.80687.43
3310066-31006688.12088.76
4311665-31166588.57489.22
5311157-31115788.43089.07
6312128-31212888.70689.34
60min1308326-30832687.62588.370.9188.4089.160.91
2306624-30662487.14187.91
3311860-31186088.62989.42
4313447-31344789.08089.87
5313001-31300188.95489.74
6312471-31247188.80389.59
极限1311430-31143088.50789.230.9389.4390.170.93
2309685-30968588.01188.93
3313913-31391389.21390.15
4315961-31596189.79590.74
5315681-31568189.71590.65
6317262-31726290.16591.10
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)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%
110.323238763243923244733241433237573241280.10
210.243242343239553240940.07
单位质量响应值RSD%判断
31407.7531649.800.55数据可信
供试品溶液-2024122521批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188682-18868253.64553.952.5453.6553.952.54
2192744-19274454.80054.80
3182698-18269851.94451.94
4192270-19227054.66554.67
5195861-19586155.68655.69
6186318-18631852.97352.97
10min1255623-25562372.67872.890.6772.7772.980.68
2255397-25539772.61372.70
3255891-25589172.75472.84
4257440-25744073.19473.29
5259284-25928473.71973.81
6254544-25454472.37172.46
15min1285353-28535381.13079.221.3081.3479.431.29
2274635-27463578.08378.30
3276948-27694878.74178.95
4278302-27830279.12679.34
5277696-27769678.95379.17
6278880-27888079.29079.50
20min1285439-28543981.15581.700.7181.5082.050.71
2286138-28613881.35481.70
3286538-28653881.46781.81
4287150-28715081.64181.99
5291170-29117082.78483.13
6287759-28775981.81482.16
30min1296055-29605584.17384.810.7084.6585.300.70
2296456-29645684.28784.77
3297449-29744984.56985.04
4300503-30050385.43885.92
5298405-29840584.84185.33
6300999-30099985.57986.06
45min1302921-30292186.12586.620.8986.7587.240.88
2302800-30280086.09186.71
3302855-30285586.10686.72
4306398-30639887.11487.74
5303660-30366086.33586.96
6309380-30938087.96288.58
60min1305089-30508986.74287.320.8387.5188.090.82
2305847-30584786.95787.72
3304969-30496986.70887.47
4308536-30853687.72288.49
5306810-30681087.23188.00
6311545-31154588.57789.34
极限1308127-30812787.60588.130.8288.5189.040.82
2307971-30797187.56188.47
3307423-30742387.40588.31
4312602-31260288.87889.79
5310316-31031688.22889.14
6313300-31330089.07689.99
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)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%
110.323244653244473243303244203243403244000.02
210.243242743239003240870.09
单位质量响应值RSD%判断
31434.1131649.120.49数据可信
供试品溶液-2024122721批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207086-20708658.85457.673.3958.8557.673.39
2192635-19263554.74754.75
3202697-20269757.60657.61
4200622-20062257.01757.02
5213186-21318660.58760.59
6201261-20126157.19857.20
10min1263738-26373874.95474.311.2475.0574.401.24
2255183-25518372.52372.61
3262822-26282274.69474.79
4261446-26144674.30374.40
5263775-26377574.96575.07
6261815-26181574.40874.50
15min1283520-28352080.57680.050.9880.8080.260.99
2277895-27789578.97879.19
3283158-28315880.47380.69
4282654-28265480.33080.55
5284239-28423980.78181.01
6278451-27845179.13679.35
20min1294104-29410483.58483.200.9283.9483.560.92
2289590-28959082.30182.65
3296619-29661984.29984.65
4293915-29391583.53083.88
5292318-29231883.07783.44
6289989-28998982.41582.77
30min1304887-30488786.64987.491.6487.1587.981.63
2309802-30980288.04688.53
3308185-30818587.58688.08
4309979-30997988.09688.59
5314515-31451589.38589.88
6299765-29976585.19385.68
45min1314251-31425189.31088.531.2189.9589.171.20
2310036-31003688.11288.74
3314956-31495689.51090.15
4314995-31499589.52190.16
5308556-30855687.69188.34
6306211-30621187.02587.66
60min1315319-31531989.61389.331.8590.4090.121.84
2312010-31201088.67389.45
3323832-32383292.03392.82
4317291-31729190.17490.96
5309363-30936387.92188.71
6308165-30816587.58088.36
极限1319485-31948590.79789.981.4191.7490.911.40
2315957-31595789.79590.72
3320238-32023891.01191.96
4321206-32120691.28792.22
5311511-31151188.53189.47
6311184-31118488.43889.36
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)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%
110.323236223235363232783231033236983234470.08
210.243226553227463227000.02
单位质量响应值RSD%判断
31341.7631513.670.39数据可信
供试品溶液-2024122721批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213671-21367160.94554.746.0660.9454.746.06
2195614-19561455.79555.79
3186955-18695553.32553.32
4183848-18384852.43952.44
5182411-18241152.02952.03
6189019-18901953.91453.91
10min1267042-26704276.16872.992.3976.2773.082.39
2256124-25612473.05473.15
3252020-25202071.88371.97
4250195-25019571.36371.45
5252499-25249972.02072.11
6257491-25749173.44473.53
15min1286820-28682081.80979.051.7882.0479.271.79
2276718-27671878.92879.14
3276896-27689678.97979.19
4273571-27357178.03078.24
5274000-27400078.15278.36
6274940-27494078.42178.63
20min1295744-29574484.35482.221.3184.7282.571.31
2286819-28681981.80982.16
3287248-28724881.93182.27
4286619-28661981.75282.09
5285345-28534581.38881.73
6287836-28783682.09982.44
30min1304906-30490686.96885.831.2187.4786.311.21
2304391-30439186.82187.30
3299162-29916285.32985.81
4301972-30197286.13186.60
5299823-29982385.51885.99
6295254-29525484.21584.69
45min1311613-31161388.88187.340.9889.5387.960.98
2305762-30576287.21287.84
3304837-30483786.94887.57
4303558-30355886.58387.20
5307318-30731887.65688.27
6304077-30407786.73187.35
60min1314285-31428589.64387.901.2290.4488.661.22
2307644-30764487.74988.52
3306174-30617487.32988.09
4305558-30555887.15487.91
5310905-31090588.67989.44
6304424-30442486.83087.59
极限1315950-31595090.11888.791.0391.0789.711.03
2310985-31098588.70289.62
3310101-31010188.45089.36
4308255-30825587.92388.83
5314265-31426589.63790.55
6308199-30819987.90788.82
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