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)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%
115.154787064786264787294786054785954786520.02
215.144809344809564809450.01
单位质量响应值RSD%判断
31594.1931766.510.39数据可信
供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1404857-40485776.37074.073.4976.3774.073.49
2370243-37024369.84169.84
3385596-38559672.73772.74
4392071-39207173.95973.96
5407687-40768776.90476.90
6395626-39562674.62974.63
10min1483989-48398991.29890.971.8991.4291.101.89
2467077-46707788.10788.22
3479373-47937390.42790.55
4488863-48886392.21792.34
5493449-49344993.08293.21
6480862-48086290.70890.83
15min1497314-49731493.81194.381.1294.0994.651.12
2494166-49416693.21793.48
3497712-49771293.88694.16
4506380-50638095.52195.80
5508038-50803895.83496.12
6498256-49825693.98994.26
20min1503456-50345694.97095.521.0295.4195.951.02
2500724-50072494.45494.87
3505380-50538095.33395.76
4515234-51523497.19297.63
5509155-50915596.04596.49
6504318-50431895.13295.56
30min1509365-50936596.08496.811.0996.6897.401.09
2508010-50801095.82996.40
3512108-51210896.60297.19
4522336-52233698.53199.13
5517435-51743597.60798.21
6509941-50994196.19396.78
45min1512887-51288796.74997.521.0997.5098.271.09
2513159-51315996.80097.54
3515574-51557497.25698.00
4526822-52682299.377100.14
5520269-52026998.14198.91
6512985-51298596.76797.52
60min1512487-51248796.67397.561.0597.5998.471.05
2513157-51315796.80097.70
3515900-51590097.31798.23
4526952-52695299.402100.33
5519638-51963898.02298.95
6514896-51489697.12898.04
极限1521560-52156098.38598.530.8899.4699.610.88
2516467-51646797.42498.48
3519157-51915797.93299.00
4528209-52820999.639100.73
5527159-52715999.441100.53
6521467-52146798.36799.44
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)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%
115.154783944788744791324789454777604786210.12
215.144817304801434809360.24
单位质量响应值RSD%判断
31592.1531765.920.39数据可信
供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1382680-38268072.19069.184.1772.1969.184.17
2367333-36733369.29569.30
3341689-34168964.45764.46
4356459-35645967.24467.24
5377345-37734571.18471.18
6374994-37499470.74070.74
10min1477342-47734290.04789.720.7990.1789.830.80
2479232-47923290.40490.52
3470344-47034488.72788.83
4478863-47886390.33490.45
5471649-47164988.97489.09
6476138-47613889.82089.94
15min1494953-49495393.37093.390.3793.6493.650.37
2495652-49565293.50293.77
3493350-49335093.06793.32
4498385-49838594.01794.28
5494007-49400793.19193.46
6493942-49394293.17993.45
20min1501798-50179894.66194.650.4295.0995.070.42
2502159-50215994.72995.15
3500170-50017094.35494.76
4505566-50556695.37295.79
5500953-50095394.50294.92
6499829-49982994.29094.71
30min1507426-50742695.72395.790.5396.3196.370.53
2506220-50622095.49596.08
3507184-50718495.67796.24
4513058-51305896.78597.36
5507297-50729795.69896.28
6505606-50560695.37995.96
45min1509325-50932596.08196.400.8496.8297.140.83
2507925-50792595.81796.56
3509057-50905796.03096.76
4518999-51899997.90698.65
5512513-51251396.68297.42
6508183-50818395.86596.60
60min1509640-50964096.14096.430.7597.0497.320.75
2507867-50786795.80696.70
3509901-50990196.19097.08
4518140-51814097.74498.65
5512825-51282596.74197.64
6508557-50855795.93696.83
极限1515721-51572197.28797.480.5098.3598.540.50
2513984-51398496.96098.02
3513797-51379796.92497.97
4518915-51891597.89098.96
5518618-51861897.83498.90
6519450-51945097.99199.05
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)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%
115.154803474802224797804793454796824798750.09
215.144813584817384815480.06
单位质量响应值RSD%判断
31674.9231806.340.30数据可信
供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1307153-30715357.83067.087.6857.8367.087.68
2342026-34202664.39664.40
3381366-38136671.80271.80
4368932-36893269.46169.46
5368589-36858969.39769.40
6369613-36961369.59069.59
10min1463243-46324387.21887.151.2387.3187.261.23
2462629-46262987.10287.21
3473534-47353489.15589.28
4461663-46166386.92087.04
5458093-45809386.24886.36
6458211-45821186.27186.39
15min1485586-48558691.42591.291.1991.6791.551.18
2489415-48941592.14692.40
3493233-49323392.86493.13
4482884-48288490.91691.18
5479760-47976090.32890.59
6478309-47830990.05590.31
20min1491375-49137592.51592.521.2492.9192.931.24
2498087-49808793.77894.18
3498710-49871093.89694.32
4490629-49062992.37492.79
5484933-48493391.30291.71
6484836-48483691.28391.69
30min1497568-49756893.68194.221.9894.2394.781.97
2518184-51818497.56298.12
3504268-50426894.94295.52
4498595-49859593.87494.44
5493121-49312192.84393.41
6490722-49072292.39292.95
45min1501132-50113294.35294.631.0495.0695.351.04
2508863-50886395.80796.53
3507566-50756695.56396.30
4504379-50437994.96395.69
5497871-49787193.73894.45
6495923-49592393.37194.09
60min1501338-50133894.39094.841.1395.2595.721.13
2510992-51099296.20897.09
3508684-50868495.77396.67
4505882-50588295.24696.13
5498028-49802893.76794.64
6497444-49744493.65794.53
极限1510791-51079196.17097.900.9597.1998.940.95
2520092-52009297.92198.97
3521525-52152598.19199.25
4525723-52572398.981100.02
5521331-52133198.15599.18
6520560-52056098.00999.04
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)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%
115.154848634847034846524851154841084846880.08
215.144811794811824811800.01
单位质量响应值RSD%判断
31992.6131782.030.47数据可信
供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1384619-38461972.08270.163.2272.0870.163.23
2375861-37586170.44170.44
3353307-35330766.21466.21
4374641-37464170.21270.21
5370595-37059569.45469.45
6387064-38706472.54072.54
10min1469747-46974788.03688.501.7488.1688.621.74
2477611-47761189.51089.63
3473161-47316188.67688.79
4475215-47521589.06189.18
5457245-45724585.69385.81
6480424-48042490.03790.16
15min1488777-48877791.60392.141.4191.8792.401.41
2494844-49484492.74093.01
3494782-49478292.72892.99
4496331-49633193.01893.28
5478799-47879989.73389.99
6496350-49635093.02293.29
20min1494240-49424092.62692.513.6393.0592.933.61
2502124-50212494.10494.53
3498630-49863093.44993.86
4506823-50682394.98595.41
5458129-45812985.85986.27
6501717-50171794.02894.45
30min1499835-49983593.67594.631.4294.2595.211.42
2508450-50845095.29095.87
3506909-50690995.00195.57
4513084-51308496.15896.74
5493253-49325392.44292.99
6508165-50816595.23695.82
45min1501289-50128993.94895.161.5894.6895.891.58
2511902-51190295.93796.67
3510951-51095195.75896.49
4517434-51743496.97397.71
5495284-49528492.82293.53
6509546-50954695.49596.24
60min1500979-50097993.88995.291.5994.7896.181.59
2513498-51349896.23697.13
3512887-51288796.12197.01
4516936-51693696.88097.78
5496247-49624793.00393.86
6510124-51012495.60396.50
极限1508446-50844695.28996.210.7996.3397.260.80
2513046-51304696.15197.21
3514373-51437396.40097.45
4519064-51906497.27998.34
5509232-50923295.43696.45
6516017-51601796.70897.77
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)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%
115.154752524745534754484750194749824750510.08
215.144831054844154837600.20
单位质量响应值RSD%判断
31356.5031952.441.34数据可信
供试品溶液-2024123021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1374415-37441570.69269.342.1670.6969.342.16
2372812-37281270.38970.39
3359297-35929767.83767.84
4357373-35737367.47467.47
5364534-36453468.82668.83
6375131-37513170.82770.83
10min1474252-47425289.54189.080.3789.6689.200.37
2471999-47199989.11689.23
3472358-47235889.18489.30
4471391-47139189.00189.11
5471999-47199989.11689.23
6468929-46892988.53688.65
15min1494140-49414093.29692.870.3093.5693.130.30
2492310-49231092.95193.22
3492606-49260693.00793.27
4490491-49049192.60792.87
5490290-49029092.56992.83
6491332-49133292.76693.03
20min1499971-49997194.39794.150.2894.8294.570.29
2500452-50045294.48894.91
3497977-49797794.02194.44
4498501-49850194.12094.53
5496601-49660193.76194.18
6498397-49839794.10094.52
30min1503842-50384295.12895.090.1495.7195.660.14
2504707-50470795.29195.87
3503791-50379195.11895.69
4503668-50366895.09595.67
5502881-50288194.94795.52
6502901-50290194.95095.53
45min1507869-50786995.88895.860.3696.6396.600.36
2508356-50835695.98096.72
3509158-50915896.13296.86
4504147-50414795.18695.92
5508144-50814495.94096.67
6508674-50867496.04096.78
60min1507817-50781795.87896.290.5596.7897.180.54
2507985-50798595.91096.81
3514496-51449697.14098.03
4507509-50750995.82096.71
5511699-51169996.61197.50
6510331-51033196.35397.25
极限1515091-51509197.25297.390.5298.3198.440.52
2515512-51551297.33198.39
3517191-51719197.64898.70
4513996-51399697.04598.09
5512701-51270196.80197.85
6520336-52033698.24299.30
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