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%
1 15.174928684922544915974918574911724919500.14
2 15.124902874911744907300.13
单位质量响应值RSD%判断
32429.1432455.690.06数据可信
供试品溶液-2024122821批-pH4.5(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%
5min1375932-37593269.24869.704.6969.2569.704.69
2388559-38855971.57471.57
3356954-35695465.75265.75
4391113-39111372.04472.04
5399487-39948773.58773.59
6358438-35843866.02566.03
10min1486002-48600289.52388.791.5789.6488.911.58
2486642-48664289.64189.76
3474823-47482387.46487.57
4472101-47210186.96387.08
5491884-49188490.60790.73
6480804-48080488.56688.68
15min1505419-50541993.10092.091.6093.3692.361.60
2502436-50243692.55092.82
3492225-49222590.66990.92
4488998-48899890.07590.34
5510019-51001993.94794.22
6500667-50066792.22592.48
20min1512830-51283094.46593.321.4094.8893.731.40
2508270-50827093.62594.05
3497969-49796991.72892.13
4498228-49822891.77592.19
5514499-51449994.77295.20
6507748-50774893.52993.94
30min1519291-51929195.65594.471.4596.2395.041.45
2513705-51370594.62695.21
3504250-50425092.88593.44
4503693-50369392.78293.35
5521250-52125096.01696.60
6515010-51501094.86795.43
45min1523351-52335196.40395.321.4397.1496.051.43
2521190-52119096.00596.74
3508581-50858193.68294.40
4508257-50825793.62394.35
5525156-52515696.73597.48
6518351-51835195.48296.21
60min1524284-52428496.57595.461.4997.4796.351.49
2522479-52247996.24297.14
3509677-50967793.88494.75
4508441-50844193.65794.54
5526647-52664797.01097.92
6517841-51784195.38896.27
极限1531655-53165597.93396.590.9198.9997.640.91
2523786-52378696.48397.54
3524304-52430496.57997.61
4518551-51855195.51996.55
5527458-52745897.16098.23
6520415-52041595.86296.91
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%
1 15.174919974916444914184916404914154916230.05
2 15.124909984911464910720.03
单位质量响应值RSD%判断
32407.5832478.310.16数据可信
供试品溶液-2024122821批-pH4.5(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%
5min1334628-33462861.63968.586.8261.6468.586.82
2369819-36981968.12168.12
3375324-37532469.13569.13
4357679-35767965.88565.88
5408927-40892775.32575.32
6387583-38758371.39371.39
10min1488217-48821789.93090.611.0590.0390.721.05
2484688-48468889.28089.39
3492699-49269990.75590.87
4498198-49819891.76891.88
5490864-49086490.41790.54
6496847-49684791.51991.64
15min1510949-51094994.11793.781.0594.3794.051.04
2502994-50299492.65292.91
3510735-51073594.07894.34
4516444-51644495.12995.39
5502796-50279692.61592.89
6510951-51095194.11794.39
20min1519744-51974495.73795.101.1496.1595.521.13
2508899-50889993.73994.16
3517909-51790995.39995.82
4523354-52335496.40296.82
5509364-50936493.82594.26
6518499-51849995.50895.94
30min1525235-52523596.74996.021.3097.3296.601.29
2513523-51352394.59195.16
3522672-52267296.27696.86
4529842-52984297.59798.18
5512930-51293094.48295.07
6523590-52359096.44697.03
45min1527608-52760897.18696.451.2497.9297.191.23
2515178-51517894.89695.63
3524329-52432996.58297.32
4531628-53162897.92698.67
5516584-51658495.15595.90
6526369-52636996.95797.71
60min1529781-52978197.58696.651.2998.4897.551.28
2516774-51677495.19096.08
3524593-52459396.63097.53
4533638-53363898.29699.20
5517119-51711995.25496.16
6526140-52614096.91597.83
极限1530012-53001297.62897.611.0898.6898.681.08
2524119-52411996.54397.59
3532109-53210998.01599.08
4539486-53948699.374100.45
5524150-52415096.54997.61
6529711-52971197.57398.64
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%
1 15.174921154909804915604916964915224915750.09
2 15.124915414918494916950.05
单位质量响应值RSD%判断
32404.4232519.510.26数据可信
供试品溶液-2024122921批-pH4.5(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%
5min1393500-39350072.44170.406.8072.4470.406.80
2386340-38634071.12271.12
3360942-36094266.44766.45
4344546-34454663.42863.43
5417977-41797776.94776.95
6391334-39133472.04272.04
10min1484471-48447189.18888.591.4989.3188.711.49
2484666-48466689.22489.34
3470039-47003986.53186.64
4475275-47527587.49587.60
5489276-48927690.07290.20
6483667-48366789.04089.16
15min1500422-50042292.12491.820.4092.3992.080.40
2499971-49997192.04192.31
3496957-49695791.48691.74
4495704-49570491.25691.51
5500191-50019192.08292.36
6499246-49924691.90892.18
20min1504348-50434892.84792.990.7393.2793.400.73
2512263-51226394.30494.72
3505249-50524993.01393.42
4502184-50218492.44992.85
5503748-50374892.73693.17
6502820-50282092.56692.99
30min1509688-50968893.83093.730.5094.4194.300.49
2508479-50847993.60794.19
3513958-51395894.61695.18
4507567-50756793.44094.00
5507802-50780293.48394.07
6507219-50721993.37593.95
45min1511707-51170794.20294.110.1794.9494.840.17
2511040-51104094.07994.81
3512074-51207494.26994.99
4511899-51189994.23794.95
5509854-50985493.86194.60
6510546-51054693.98894.72
60min1512684-51268494.38294.430.2195.2795.320.20
2514225-51422594.66595.56
3513184-51318494.47495.35
4513791-51379194.58595.46
5511226-51122694.11395.01
6512709-51270994.38695.27
极限1524101-52410196.48396.460.3197.5397.500.32
2525803-52580396.79797.85
3524399-52439996.53897.57
4521058-52105895.92396.95
5524956-52495696.64197.70
6523564-52356496.38497.43
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%
1 15.174911914908274913864915644910904912120.06
2 15.124912674911054911860.03
单位质量响应值RSD%判断
32380.4932485.850.23数据可信
供试品溶液-2024122921批-pH4.5(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%
5min1402621-40262174.18569.516.9174.1969.516.92
2356281-35628165.64765.65
3362391-36239166.77366.77
4345125-34512563.59163.59
5407307-40730775.04975.05
6389819-38981971.82771.83
10min1509479-50947993.87590.002.9694.0090.122.96
2467284-46728486.10086.21
3479047-47904788.26788.38
4487299-48729989.78889.89
5492775-49277590.79790.92
6494849-49484991.17991.30
15min1525344-52534496.79893.232.2097.0893.502.20
2492269-49226990.70490.96
3499277-49927791.99592.25
4504305-50430592.92193.18
5506258-50625893.28193.56
6508479-50847993.69093.96
20min1530747-53074797.79394.351.9498.2394.771.94
2501252-50125292.35992.76
3509285-50928593.83994.25
4509615-50961593.90094.31
5509065-50906593.79894.23
6512404-51240494.41494.84
30min1535638-53563898.69595.082.0399.3095.662.03
2505131-50513193.07493.63
3510013-51001393.97394.54
4513947-51394794.69895.26
5515262-51526294.94095.53
6516274-51627495.12795.71
45min1538349-53834999.19495.572.0699.9696.302.06
2507522-50752293.51494.23
3512098-51209894.35795.08
4516532-51653295.17495.90
5520691-52069195.94196.69
6516800-51680095.22495.97
60min1540719-54071999.63195.842.16100.5796.732.16
2507642-50764293.53694.41
3513501-51350194.61695.50
4518189-51818995.48096.36
5520110-52011095.83496.74
6520541-52054195.91396.82
极限1541820-54182099.83497.051.43100.9398.101.43
2524046-52404696.55997.58
3524576-52457696.65697.70
4524531-52453196.64897.69
5521806-52180696.14697.21
6523384-52338496.43797.50
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