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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
114.764734234737334735434733374731794734430.05
214.794721104725794723440.08
单位质量响应值RSD%判断
32076.0831936.710.31数据可信
供试品溶液-第1批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341133-34113363.43861.832.6663.4461.832.66
2344985-34498564.15564.15
3330087-33008761.38461.38
4328909-32890961.16561.17
5328639-32863961.11561.11
6321254-32125459.74259.74
10min1412887-41288776.78275.510.9376.8975.620.93
2405598-40559875.42775.53
3406226-40622675.54375.65
4403750-40375075.08375.18
5401865-40186574.73274.83
6406063-40606375.51375.61
15min1440051-44005181.83480.411.0182.0780.641.01
2430509-43050980.05980.29
3431907-43190780.31980.55
4430655-43065580.08680.31
5427262-42726279.45579.68
6434138-43413880.73480.96
20min1453852-45385284.40082.971.0584.7783.341.05
2442867-44286782.35782.72
3446766-44676683.08283.44
4444607-44460782.68183.04
5440604-44060481.93682.30
6448398-44839883.38683.75
30min1470345-47034587.46785.791.1287.9886.291.12
2458657-45865785.29485.80
3460504-46050485.63786.14
4459897-45989785.52486.02
5455180-45518084.64785.14
6463400-46340086.17686.67
45min1481839-48183989.60588.001.0590.2688.641.05
2470831-47083187.55788.20
3472394-47239487.84888.49
4472724-47272487.91088.55
5466930-46693086.83287.47
6474384-47438488.21888.86
60min1487679-48767990.69189.181.0591.5089.971.05
2478925-47892589.06389.85
3480397-48039789.33690.13
4477135-47713588.73089.52
5472326-47232687.83588.62
6480721-48072189.39790.19
极限1499798-49979892.94491.471.1293.9092.411.11
2489011-48901190.93891.88
3497094-49709492.44193.38
4489173-48917390.96891.90
5485341-48534190.25691.18
6490821-49082191.27592.21
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
114.764734024735914736894733134733174734620.04
214.794728684729974729320.02
单位质量响应值RSD%判断
32077.3731976.470.23数据可信
供试品溶液-第2批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312630-31263058.10061.705.2758.1061.705.26
2333328-33332861.94761.95
3354768-35476865.93265.93
4341966-34196663.55263.55
5339214-33921463.04163.04
6310128-31012857.63557.64
10min1431987-43198780.28280.982.7080.3881.092.70
2440918-44091881.94282.05
3456077-45607784.75984.87
4431204-43120480.13780.24
5432947-43294780.46180.57
6421372-42137278.31078.41
15min1465867-46586786.57986.731.6386.8186.961.63
2467229-46722986.83287.07
3481260-48126089.43989.69
4463011-46301186.04886.29
5461950-46195085.85186.09
6460629-46062985.60585.83
20min1480456-48045689.29089.261.3889.6689.641.38
2478439-47843988.91589.30
3493260-49326091.66992.07
4476838-47683888.61889.00
5474824-47482488.24388.63
6477979-47797988.83089.20
30min1493830-49383091.77591.601.3392.3092.131.34
2490158-49015891.09391.63
3504523-50452393.76394.32
4491559-49155991.35391.88
5484627-48462790.06590.59
6492539-49253991.53592.05
45min1503771-50377193.62393.441.1394.3094.121.13
2498037-49803792.55793.24
3513544-51354495.43996.15
4500054-50005492.93293.61
5499287-49928792.79093.47
6502002-50200293.29493.96
60min1507439-50743994.30594.181.2795.1495.021.28
2501752-50175293.24894.09
3519079-51907996.46897.34
4504838-50483893.82194.66
5501878-50187893.27194.11
6505523-50552393.94894.77
极限1518708-51870896.39996.190.9497.3997.180.95
2513468-51346895.42596.42
3526479-52647997.84398.87
4517255-51725596.12997.12
5513333-51333395.40096.39
6516209-51620995.93496.92
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
114.764733404734154734994732944732124733520.03
214.794722294722924722600.01
单位质量响应值RSD%判断
32069.9231931.030.31数据可信
供试品溶液-第3批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1289562-28956253.85853.871.3653.8653.871.35
2289692-28969253.88253.88
3293675-29367554.62354.62
4294058-29405854.69454.69
5283834-28383452.79352.79
6286995-28699553.38153.38
10min1388745-38874572.30672.470.8372.4072.560.83
2391305-39130572.78272.87
3393710-39371073.22973.32
4384126-38412671.44771.54
5389160-38916072.38372.47
6390611-39061172.65372.74
15min1425833-42583379.20479.031.0679.4179.241.05
2428356-42835679.67379.88
3428080-42808079.62279.84
4416187-41618777.41077.62
5425224-42522479.09179.30
6425798-42579879.19879.41
20min1442944-44294482.38781.831.4282.7382.171.42
2443727-44372782.53282.88
3446043-44604382.96383.31
4434093-43409380.74081.08
5442548-44254882.31382.65
6430295-43029580.03480.38
30min1462946-46294686.10785.661.1186.5986.141.11
2462685-46268586.05986.54
3464759-46475986.44486.93
4450539-45053983.79984.27
5461507-46150785.83986.32
6460972-46097285.74086.22
45min1476225-47622588.57788.451.1389.2089.071.13
2476409-47640988.61189.24
3481094-48109489.48390.11
4465268-46526886.53987.15
5476749-47674988.67489.30
6477367-47736788.78989.41
60min1484328-48432890.08490.141.2690.8590.911.26
2485656-48565690.33191.10
3491790-49179091.47292.25
4473409-47340988.05388.81
5485379-48537990.28091.05
6487355-48735590.64791.41
极限1497640-49764092.56091.891.0493.4892.801.04
2494821-49482192.03692.96
3497960-49796092.62093.55
4484352-48435290.08990.99
5496592-49659292.36593.28
6492745-49274591.65092.57
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
114.764726504726064727484727584722634726050.05
214.794744364748704746530.07
单位质量响应值RSD%判断
32019.3132092.830.17数据可信
供试品溶液-第4批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1291457-29145754.11651.033.4554.1251.033.46
2275868-27586851.22251.22
3276690-27669051.37451.37
4272383-27238350.57550.57
5269393-26939350.02050.02
6263335-26333548.89548.89
10min1393637-39363773.08971.261.9473.1871.341.94
2390204-39020472.45172.54
3386170-38617071.70271.79
4380205-38020570.59570.68
5377816-37781670.15170.23
6374683-37468369.56969.65
15min1426746-42674679.23678.031.2279.4578.231.22
2424995-42499578.91179.12
3422132-42213278.37978.58
4417492-41749277.51877.72
5414832-41483277.02477.22
6415332-41533277.11777.31
20min1444535-44453582.53981.621.1682.8881.961.16
2445888-44588882.79083.13
3441007-44100781.88482.22
4436580-43658081.06281.39
5432817-43281780.36380.69
6436814-43681481.10581.43
30min1462993-46299385.96685.100.9186.4585.570.91
2462125-46212585.80586.28
3460036-46003685.41785.89
4456948-45694884.84485.31
5452345-45234583.98984.45
6455406-45540684.55785.02
45min1479455-47945589.02387.950.8589.6588.570.85
2475475-47547588.28488.90
3475982-47598288.37888.99
4472057-47205787.64988.26
5468609-46860987.00987.61
6470636-47063687.38587.99
60min1489174-48917490.82789.471.0891.6090.231.09
2486379-48637990.30891.07
3482931-48293189.66890.43
4477760-47776088.70889.46
5475918-47591888.36689.11
6479047-47904788.94789.69
极限1492934-49293491.52590.940.4892.4591.850.49
2492097-49209791.37092.29
3489994-48999490.98091.89
4488067-48806790.62291.52
5487289-48728990.47791.37
6488344-48834490.67391.57
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
114.764738264741144739634738384734224738330.06
214.794739804740444740120.01
单位质量响应值RSD%判断
32102.5132049.490.12数据可信
供试品溶液批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1293568-29356854.47454.342.4454.4754.342.44
2291246-29124654.04354.04
3296625-29662555.04255.04
4298431-29843155.37755.38
5279389-27938951.84351.84
6297783-29778355.25655.26
10min1385812-38581271.59172.521.2571.6872.611.25
2391552-39155272.65672.75
3391254-39125472.60172.69
4397442-39744273.74973.84
5384702-38470271.38571.47
6394048-39404873.11973.21
15min1423179-42317978.52579.000.8978.7379.210.89
2426348-42634879.11379.32
3425881-42588179.02679.24
4432443-43244380.24480.46
5421398-42139878.19478.40
6425286-42528678.91679.13
20min1443299-44329982.25882.250.9782.6082.600.97
2443035-44303582.20982.55
3443582-44358282.31182.66
4450923-45092383.67384.02
5438228-43822881.31781.65
6440534-44053481.74582.09
30min1463607-46360786.02785.880.8186.5086.360.81
2462307-46230785.78586.27
3463372-46337285.98386.46
4469271-46927187.07887.57
5459158-45915885.20185.67
6459246-45924685.21785.70
45min1479143-47914388.90988.850.7689.5389.470.77
2479578-47957888.99089.61
3477344-47734488.57689.20
4485044-48504490.00490.64
5473945-47394587.94588.56
6477895-47789588.67889.30
60min1486205-48620590.22090.200.7290.9990.970.72
2485080-48508090.01190.78
3485881-48588190.16090.93
4492687-49268791.42392.21
5482698-48269889.56990.33
6484067-48406789.82390.59
极限1494084-49408491.68291.380.8892.6092.300.88
2494169-49416991.69892.62
3491789-49178991.25692.18
4499013-49901392.59793.53
5487040-48704090.37591.28
6488584-48858490.66191.58
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