氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.111839461839611838891840111843011840220.09
214.131839701838261838980.06
单位质量响应值RSD%判断
13041.9613014.720.15数据可信
供试品溶液-2025102421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min140878-4087822.19326.349.6722.1926.349.68
246770-4677025.39225.39
352169-5216928.32328.32
446419-4641925.20125.20
551993-5199328.22828.23
652852-5285228.69428.69
5min1119376-11937664.81163.121.9464.8163.121.94
2118137-11813764.13864.14
3116476-11647663.23663.24
4115850-11585062.89662.90
5114161-11416161.97961.98
6113528-11352861.63661.64
10min1136640-13664074.18372.333.3974.1872.323.38
2124273-12427367.46967.47
3134624-13462473.08973.09
4133576-13357672.52072.52
5134610-13461073.08173.08
6135589-13558973.61373.61
15min1149525-14952581.17978.321.9281.1878.321.92
2141939-14193977.06077.06
3142293-14229377.25277.25
4143864-14386478.10578.11
5143340-14334077.82177.82
6144543-14454378.47478.47
20min1151290-15129082.13780.221.9082.1480.221.90
2149315-14931581.06581.06
3143081-14308177.68077.68
4148597-14859780.67580.67
5146510-14651079.54279.54
6147735-14773580.20780.21
30min1155887-15588784.63382.032.8684.6382.032.86
2145778-14577879.14479.14
3145656-14565679.07879.08
4152629-15262982.86482.86
5153259-15325983.20683.21
6153379-15337983.27183.27
45min1159691-15969186.69884.371.8586.7084.371.85
2152409-15240982.74582.74
3154179-15417983.70583.71
4152764-15276482.93782.94
5155653-15565384.50684.51
6157676-15767685.60485.60
60min1160926-16092687.36884.233.6287.3784.233.62
2157206-15720685.34985.35
3155799-15579984.58584.58
4153601-15360183.39283.39
5144853-14485378.64278.64
6158476-15847686.03886.04
90min1162426-16242688.18385.571.8588.1885.571.85
2154361-15436183.80483.80
3154984-15498484.14384.14
4157125-15712585.30585.30
5158253-15825385.91785.92
6158516-15851686.06086.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1156558-15655884.99785.571.9785.0085.571.96
2161616-16161687.74387.74
3155872-15587284.62584.62
4153061-15306183.09883.10
5160062-16006286.89986.90
6158537-15853786.07186.07
极限1162699-16269988.33186.031.3888.3386.031.38
2158420-15842086.00886.01
3157093-15709385.28885.29
4156827-15682785.14385.14
5158276-15827685.93085.93
6157417-15741785.46385.46
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.111831381833061834481829381831411831940.11
214.131840391834131837260.25
单位质量响应值RSD%判断
12983.2713002.550.11数据可信
供试品溶液-2025102421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min159703-5970332.50227.1812.3032.5027.1812.30
252349-5234928.49828.50
350638-5063827.56727.57
443684-4368423.78123.78
550176-5017627.31527.32
643037-4303723.42923.43
5min1114066-11406662.09760.004.8262.1060.004.82
2115172-11517262.69962.70
3112214-11221461.08861.09
4102128-10212855.59855.60
5105083-10508357.20657.21
6112654-11265461.32861.33
10min1137301-13730174.74572.842.9474.7572.842.95
2138183-13818375.22675.23
3127844-12784469.59769.60
4131865-13186571.78671.79
5131991-13199171.85571.85
6135639-13563973.84173.84
15min1139083-13908375.71677.411.8675.7277.411.86
2146276-14627679.63179.63
3140723-14072376.60876.61
4144268-14426878.53878.54
5140757-14075776.62776.63
6142033-14203377.32177.32
20min1149154-14915481.19880.142.9681.2080.142.96
2153867-15386783.76483.76
3141299-14129976.92276.92
4148028-14802880.58580.59
5147013-14701380.03380.03
6143934-14393478.35678.36
30min1149873-14987381.59082.391.7081.5982.391.70
2155118-15511884.44584.44
3151007-15100782.20782.21
4150102-15010281.71481.71
5153670-15367083.65783.66
6148267-14826780.71580.72
45min1143069-14306977.88581.893.3177.8981.893.31
2146408-14640879.70379.70
3152580-15258083.06383.06
4157131-15713185.54185.54
5152245-15224582.88182.88
6151087-15108782.25082.25
60min1155385-15538584.59084.073.8884.5984.073.88
2158921-15892186.51586.52
3142713-14271377.69277.69
4158756-15875686.42586.43
5155317-15531784.55384.55
6155440-15544084.62084.62
90min1146900-14690079.97184.563.0379.9784.563.03
2157341-15734185.65585.66
3154780-15478084.26184.26
4161190-16119087.75087.75
5156033-15603384.94384.94
6155762-15576284.79584.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1154103-15410383.89285.011.9083.8985.011.91
2155625-15562584.72184.72
3156267-15626785.07085.07
4160888-16088887.58687.59
5152330-15233082.92782.93
6157711-15771185.85685.86
极限1155425-15542584.61285.402.2684.6185.402.26
2161076-16107687.68887.69
3156304-15630485.09085.09
4160806-16080687.54187.54
5151787-15178782.63182.63
6155807-15580784.82084.82
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.111790601791551792761790701789941791110.07
214.131794111794961794540.04
单位质量响应值RSD%判断
12693.9112700.210.04数据可信
供试品溶液-2025102521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min149630-4963027.64826.188.1927.6526.188.19
246259-4625925.77025.77
340132-4013222.35722.36
451124-5112428.48028.48
546417-4641725.85825.86
648427-4842726.97726.98
5min1105002-10500258.49459.857.3258.4959.847.33
2113121-11312163.01763.02
3111335-11133562.02262.02
492437-9243751.49451.49
5111641-11164162.19262.19
6111046-11104661.86161.86
10min1129259-12925972.00773.183.7772.0173.183.77
2130204-13020472.53372.53
3135182-13518275.30775.31
4122931-12293168.48268.48
5135108-13510875.26575.27
6135464-13546475.46475.46
15min1132305-13230573.70477.194.1873.7077.194.18
2142719-14271979.50579.51
3140566-14056678.30678.31
4130178-13017872.51972.52
5142443-14244379.35279.35
6143174-14317479.75979.76
20min1142888-14288879.59980.711.9179.6080.711.91
2145290-14529080.93780.94
3148104-14810482.50582.51
4140573-14057378.31078.31
5147085-14708581.93781.94
6145300-14530080.94380.94
30min1146903-14690381.83683.382.5181.8483.382.51
2148524-14852482.73982.74
3153788-15378885.67285.67
4144548-14454880.52480.52
5153851-15385185.70785.71
6150444-15044483.80983.81
45min1149993-14999383.55784.682.0483.5684.682.04
2150167-15016783.65483.65
3152678-15267885.05385.05
4150001-15000183.56283.56
5157952-15795287.99187.99
6151226-15122684.24484.24
60min1150095-15009583.61486.431.9183.6186.431.91
2157166-15716687.55387.55
3158013-15801388.02588.03
4153243-15324385.36885.37
5156063-15606386.93986.94
6156293-15629387.06787.07
90min1151686-15168684.50186.961.7684.5086.961.76
2157417-15741787.69387.69
3158873-15887388.50488.50
4153836-15383685.69885.70
5157702-15770287.85287.85
6157122-15712287.52987.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1154679-15467986.16887.081.1686.1787.081.16
2158072-15807288.05888.06
3157321-15732187.64087.64
4155179-15517986.44686.45
5158348-15834888.21288.21
6154281-15428185.94685.95
极限1154810-15481086.24186.662.4286.2486.662.42
2157995-15799588.01588.02
3160107-16010789.19289.19
4153529-15352985.52785.53
5157337-15733787.64987.65
6149557-14955783.31583.31
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.111836431838761840931839301834801838040.14
214.131834101837511835800.14
单位质量响应值RSD%判断
13026.5112992.220.19数据可信
供试品溶液-2025102521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min136142-3614219.65122.9214.6819.6522.9214.67
245046-4504624.49224.49
342498-4249823.10623.11
434477-3447718.74518.75
551444-5144427.97027.97
643320-4332023.55323.55
5min193824-9382451.01254.399.7551.0154.399.75
2113487-11348761.70361.70
396709-9670952.58152.58
492375-9237550.22550.22
5111357-11135760.54560.55
692454-9245450.26850.27
10min1127263-12726369.19370.234.2769.1970.224.27
2136260-13626074.08574.09
3127412-12741269.27469.27
4129564-12956470.44470.44
5133839-13383972.76972.77
6120644-12064465.59565.59
15min1135089-13508973.44876.643.6473.4576.643.64
2146204-14620479.49279.49
3141925-14192577.16577.17
4141503-14150376.93676.94
5146338-14633879.56479.56
6134683-13468373.22873.23
20min1149050-14905081.03980.452.4981.0480.452.49
2148450-14845080.71380.71
3148641-14864180.81780.82
4148855-14885580.93380.93
5151869-15186982.57282.57
6140900-14090076.60876.61
30min1152927-15292783.14783.190.8383.1583.190.83
2153634-15363483.53183.53
3153446-15344683.42983.43
4152882-15288283.12283.12
5154415-15441583.95683.96
6150687-15068781.92981.93
45min1154952-15495284.24884.451.2784.2584.461.27
2153151-15315183.26983.27
3158279-15827986.05786.06
4156600-15660085.14485.14
5155657-15565784.63184.63
6153353-15335383.37983.38
60min1156554-15655485.11985.000.9085.1285.000.90
2154693-15469384.10784.11
3155565-15556584.58184.58
4155533-15553384.56484.56
5158643-15864386.25586.25
6157033-15703385.37985.38
90min1159372-15937286.65186.271.0586.6586.271.05
2158022-15802285.91785.92
3157674-15767485.72885.73
4159617-15961786.78486.78
5161020-16102087.54787.55
6156331-15633184.99885.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1161098-16109887.59086.211.0887.5986.211.07
2157574-15757485.67485.67
3159589-15958986.76986.77
4156437-15643785.05585.06
5159128-15912886.51886.52
6157517-15751785.64385.64
极限1157289-15728985.51986.831.4285.5286.831.42
2157075-15707585.40285.40
3162404-16240488.30088.30
4159789-15978986.87886.88
5162026-16202688.09488.09
6159660-15966086.80886.81
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