盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.557975937979187972857974187977027975830.04
212.547956827933987945400.21
单位质量响应值RSD%判断
63552.4363360.450.22数据可信
加速6月-供试品溶液-2024072721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1800673-80067395.23795.751.2495.2495.751.24
2803143-80314395.53195.53
3793074-79307494.33394.33
4801144-80114495.29395.29
5809938-80993896.33996.34
6821979-82197997.77297.77
10min1814970-81497096.93898.011.2197.1098.171.21
2824270-82427098.04498.20
3813044-81304496.70996.87
4824435-82443598.06498.22
5826069-82606998.25898.42
6840922-840922100.025100.19
15min1817047-81704797.18598.251.0597.5198.571.05
2827997-82799798.48798.81
3816640-81664097.13797.45
4827030-82703098.37298.69
5827086-82708698.37998.70
6839973-83997399.912100.24
20min1827819-82781998.46698.680.8198.9599.160.81
2832061-83206198.97199.46
3819636-81963697.49397.97
4829120-82912098.62199.11
5828692-82869298.57099.06
6840222-84022299.942100.44
30min1835527-83552799.38399.380.65100.03100.030.65
2840548-84054899.980100.63
3826716-82671698.33598.98
4833409-83340999.13199.78
5834928-83492899.31299.96
6841756-841756100.124100.79
45min1839564-83956499.86399.750.67100.68100.560.67
2846637-846637100.705101.52
3829141-82914198.62499.43
4838978-83897899.794100.61
5837605-83760599.630100.45
6839545-83954599.861100.69
60min1842455-842455100.20799.760.71101.19100.740.70
2845107-845107100.523101.51
3827900-82790098.47699.45
4839821-83982199.894100.88
5838711-83871199.762100.75
6838018-83801899.679100.68
极限1834019-83401999.20499.420.70100.35100.570.70
2843835-843835100.371101.53
3825977-82597798.24799.38
4836723-83672399.525100.67
5837544-83754499.623100.77
6836983-83698399.556100.72
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.557954567923047917037926527936097931450.19
212.547931177907077919120.22
单位质量响应值RSD%判断
63198.8063150.880.06数据可信
加速6月-供试品溶液-2024072921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1802204-80220495.84592.843.9095.8492.843.90
2803014-80301495.94195.94
3807669-80766996.49796.50
4753536-75353690.03090.03
5741667-74166788.61288.61
6754003-75400390.08690.09
10min1823598-82359898.40197.192.7598.5697.352.75
2832729-83272999.49299.65
3842922-842922100.709100.87
4793828-79382894.84494.99
5796067-79606795.11195.26
6791882-79188294.61194.76
15min1826551-82655198.75397.662.9199.0897.982.91
2840699-840699100.444100.77
3846888-846888101.183101.51
4796176-79617695.12495.43
5802082-80208295.83096.14
6792147-79214794.64394.95
20min1822424-82242498.26097.722.4198.7598.202.41
2834484-83448499.701100.19
3846216-846216101.103101.60
4804499-80449996.11996.59
5800574-80057495.65096.12
6799005-79900595.46295.93
30min1826147-82614798.70598.621.9299.3699.261.92
2837443-837443100.055100.71
3850213-850213101.581102.25
4816557-81655797.55998.19
5811269-81126996.92897.55
6810985-81098596.89497.52
45min1832072-83207299.41399.241.71100.23100.041.71
2828657-82865799.00599.83
3856464-856464102.327103.16
4829879-82987999.15199.94
5815168-81516897.39398.18
6821374-82137498.13598.92
60min1830698-83069899.24999.581.48100.23100.561.48
2836194-83619499.906100.90
3854411-854411102.082103.09
4836682-83668299.964100.92
5820626-82062698.04698.99
6822313-82231398.24799.20
极限1832942-83294299.51799.961.59100.66101.101.59
2830227-83022799.193100.35
3859997-859997102.749103.93
4844160-844160100.857101.98
5824144-82414498.46699.58
6828387-82838798.973100.09
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.557914127907967942547907337916397917670.19
212.547938617976437957520.34
单位质量响应值RSD%判断
63089.0063457.100.42数据可信
加速6月-供试品溶液-2024073021批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1797121-79712195.09090.597.9795.0990.597.97
2780008-78000893.04993.05
3755790-75579090.16090.16
4763708-76370891.10491.10
5644291-64429176.85976.86
6815486-81548697.28197.28
10min1820989-82098997.93793.986.0398.1094.146.03
2804899-80489996.01896.17
3774555-77455592.39892.55
4792722-79272294.56594.72
5700624-70062483.57983.71
6833284-83328499.40499.57
15min1829635-82963598.96994.715.5399.2995.025.53
2808674-80867496.46896.78
3780943-78094393.16093.46
4796196-79619694.98095.29
5714244-71424485.20485.47
6833836-83383699.47099.80
20min1836688-83668899.81095.224.85100.3095.684.86
2798850-79885095.29695.77
3785679-78567993.72594.18
4801794-80179495.64896.12
5731258-73125887.23387.64
6834752-83475299.579100.07
30min1837437-83743799.90096.643.81100.5597.263.82
2815168-81516897.24397.88
3795738-79573894.92595.54
4819333-81933397.74098.37
5755805-75580590.16290.72
6837154-83715499.866100.53
45min1838574-838574100.03597.802.61100.8598.582.64
2817674-81767497.54298.34
3813146-81314697.00297.78
4832023-83202399.254100.04
5781405-78140593.21593.92
6836018-83601899.730100.56
60min1849797-849797101.37498.522.15102.3699.472.18
2821094-82109497.95098.91
3819825-81982597.79998.73
4835996-83599699.728100.68
5797342-79734295.11795.98
6831165-83116599.151100.14
极限1841007-841007100.32599.511.00101.48100.630.98
2819728-81972897.78798.91
3830851-83085199.114100.21
4840908-840908100.314101.44
5839504-839504100.146101.17
6833182-83318299.392100.55
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.557872717943697943037890057922137914320.41
212.547937787872997905380.58
单位质量响应值RSD%判断
63062.3163041.310.03数据可信
加速6月-供试品溶液-BXJX091批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1661861-66186179.23187.076.5079.2387.076.50
2723433-72343386.60286.60
3701912-70191284.02684.03
4713491-71349185.41285.41
5773885-77388592.64292.64
6789413-78941394.50094.50
10min1741049-74104988.71192.624.1188.8492.774.11
2767791-76779191.91292.06
3744398-74439889.11289.25
4764608-76460891.53191.67
5808923-80892396.83696.99
6815621-81562197.63897.80
15min1761024-76102491.10293.772.9891.3894.072.99
2770876-77087692.28192.58
3763986-76398691.45791.75
4779473-77947393.31093.61
5811754-81175497.17597.49
6812906-81290697.31397.63
20min1772759-77275992.50794.732.6592.9495.182.66
2783114-78311493.74694.20
3770696-77069692.26092.70
4787164-78716494.23194.68
5814684-81468497.52698.00
6819461-81946198.09798.58
30min1797823-79782395.50796.361.7396.0996.981.74
2795514-79551495.23195.84
3786638-78663894.16894.76
4810725-81072597.05297.66
5815781-81578197.65798.30
6823386-82338698.56799.21
45min1811622-81162297.15996.801.5197.9097.571.51
2799321-79932195.68696.45
3788472-78847294.38895.14
4817685-81768597.88598.65
5817490-81749097.86198.66
6817261-81726197.83498.64
60min1819568-81956898.11097.261.3999.0298.201.38
2799841-79984195.74996.67
3797570-79757095.47796.39
4825532-82553298.82499.76
5816996-81699697.80298.77
6815224-81522497.59098.56
极限1841941-841941100.78897.841.99101.8698.941.97
2801294-80129495.92397.01
3797853-79785395.51196.58
4825801-82580198.85699.95
5817459-81745997.85898.99
6819564-81956498.11099.25
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