氢溴酸氟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%
113.781733601753761751221748101757351748810.53
213.831755241763001759120.32
单位质量响应值RSD%判断
12690.9312719.600.16数据可信
中间条件6月-供试品溶液-2025102321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%
2min149708-4970827.67331.5912.9027.6731.5912.90
260750-6075033.82133.82
352870-5287029.43429.43
448365-4836526.92626.93
564875-6487536.11736.12
663857-6385735.55035.55
5min1106473-10647359.27563.435.6859.2863.435.68
2118131-11813165.76565.77
3107978-10797860.11360.11
4110293-11029361.40261.40
5121811-12181167.81467.81
6118948-11894866.22066.22
10min1126131-12613170.21973.173.5570.2273.163.55
2132326-13232673.66873.67
3128168-12816871.35371.35
4130557-13055772.68372.68
5139702-13970277.77477.77
6131667-13166773.30173.30
15min1120952-12095267.33673.734.8667.3473.734.86
2134968-13496875.13975.14
3134753-13475375.01975.02
4129075-12907571.85871.86
5138398-13839877.04877.05
6136453-13645375.96675.97
20min1132277-13227773.64177.933.4373.6477.933.43
2141661-14166178.86578.87
3136571-13657176.03176.03
4140430-14043078.18078.18
5145025-14502580.73880.74
6143918-14391880.12280.12
30min1136694-13669476.10079.743.3076.1079.743.29
2143450-14345079.86179.86
3141910-14191079.00479.00
4140553-14055378.24878.25
5150103-15010383.56583.56
6146724-14672481.68481.68
45min1139320-13932077.56280.221.9277.5680.221.92
2142892-14289279.55079.55
3144213-14421380.28680.29
4145027-14502780.73980.74
5146004-14600481.28381.28
6147148-14714881.92081.92
60min1140645-14064578.29980.983.2778.3080.983.27
2147820-14782082.29482.29
3142898-14289879.55479.55
4142971-14297179.59479.59
5153849-15384985.65085.65
6144601-14460180.50280.50
90min1138446-13844677.07579.482.1877.0879.482.18
2143943-14394380.13580.14
3140481-14048178.20878.21
4141649-14164978.85878.86
5146375-14637581.48981.49
6145734-14573481.13381.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1139681-13968177.76380.642.4977.7680.642.49
2143572-14357279.92979.93
3144984-14498480.71580.71
4143033-14303379.62979.63
5149148-14914883.03383.03
6148652-14865282.75782.76
极限1140111-14011178.00281.022.4278.0081.022.42
2145202-14520280.83680.84
3143046-14304679.63679.64
4146972-14697281.82281.82
5149645-14964583.31083.31
6148202-14820282.50682.51
氢溴酸氟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%
113.781758311763971764981759641764161762210.18
213.831762411760471761440.08
单位质量响应值RSD%判断
12788.1712736.370.29数据可信
中间条件6月-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%
2min165216-6521636.14539.868.2836.1439.868.29
278865-7886543.70943.71
371762-7176239.77339.77
467732-6773237.53937.54
568570-6857038.00438.00
679349-7934943.97843.98
5min1116797-11679764.73366.642.9764.7366.642.98
2116131-11613164.36364.36
3123696-12369668.55668.56
4124978-12497869.26769.27
5120274-12027466.66066.66
6119541-11954166.25366.25
10min1135303-13530374.98978.323.3174.9978.323.32
2144096-14409679.86379.86
3138501-13850176.76276.76
4143912-14391279.76179.76
5138315-13831576.65876.66
6147782-14778281.90581.91
15min1146119-14611980.98482.861.6580.9882.861.65
2148582-14858282.34982.35
3148000-14800082.02682.03
4152597-15259784.57484.57
5149701-14970182.96982.97
6152001-15200184.24484.24
20min1151353-15135383.88585.131.8983.8885.121.89
2154967-15496785.88885.89
3153374-15337485.00585.00
4150785-15078583.57083.57
5152405-15240584.46884.47
6158678-15867887.94487.94
30min1145431-14543180.60285.102.8980.6085.102.89
2155185-15518586.00886.01
3155757-15575786.32586.33
4154699-15469985.73985.74
5152043-15204384.26784.27
6158143-15814387.64887.65
45min1143785-14378579.69086.174.5379.6986.164.53
2159035-15903588.14288.14
3158847-15884788.03888.04
4158595-15859587.89887.90
5150123-15012383.20383.20
6162423-16242390.02090.02
60min1149317-14931782.75687.032.5382.7687.032.53
2158781-15878188.00188.00
3157372-15737287.22087.22
4158130-15813087.64187.64
5157785-15778587.44987.45
6160794-16079489.11789.12
90min1145209-14520980.47985.823.1180.4885.823.11
2155500-15550086.18386.18
3157702-15770287.40387.40
4156872-15687286.94386.94
5155971-15597186.44486.44
6157846-15784687.48387.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1145941-14594180.88586.364.1280.8986.364.11
2158538-15853887.86787.87
3158868-15886888.05088.05
4159004-15900488.12588.12
5149936-14993683.09983.10
6162605-16260590.12190.12
极限1155052-15505285.93587.801.2485.9387.801.24
2157279-15727987.16987.17
3158587-15858787.89487.89
4160028-16002888.69388.69
5159510-15951088.40588.41
6160074-16007488.71888.72
氢溴酸氟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%
113.781763601760191766301763591757901762320.19
213.831750531748191749360.10
单位质量响应值RSD%判断
12788.9712649.020.78数据可信
中间条件6月-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%
2min145105-4510525.08437.2937.9325.0837.3037.93
298056-9805654.53254.53
351871-5187128.84728.85
451212-5121228.48128.48
554964-5496430.56730.57
6101156-10115656.25656.26
5min1111705-11170562.12367.078.8162.1267.088.82
2136202-13620275.74675.75
3113641-11364163.19963.20
4126424-12642470.30870.31
5126331-12633170.25770.26
6109341-10934160.80860.81
10min1141663-14166378.78379.182.7678.7879.182.76
2137101-13710176.24676.25
3138676-13867677.12277.12
4145356-14535680.83780.84
5144382-14438280.29580.30
6147071-14707181.79181.79
15min1135578-13557875.39983.205.2375.4083.205.23
2154868-15486886.12786.13
3148309-14830982.47982.48
4148343-14834382.49882.50
5152620-15262084.87784.88
6157906-15790687.81687.82
20min1139767-13976777.72983.744.6977.7383.744.69
2153740-15374085.50085.50
3149373-14937383.07183.07
4145862-14586281.11881.12
5155521-15552186.49086.49
6159154-15915488.51188.51
30min1151711-15171184.37186.992.3884.3786.992.38
2154848-15484886.11686.12
3154011-15401185.65085.65
4156297-15629786.92286.92
5160786-16078689.41889.42
6160846-16084689.45289.45
45min1144730-14473080.48984.964.4680.4984.964.46
2145516-14551680.92680.93
3154254-15425485.78585.79
4151792-15179284.41684.42
5159160-15916088.51488.51
6161170-16117089.63289.63
60min1152910-15291085.03887.071.9085.0487.071.90
2154879-15487986.13386.13
3154623-15462385.99185.99
4159417-15941788.65788.66
5157077-15707787.35587.36
6160508-16050889.26489.26
90min1151132-15113284.04985.215.3884.0585.215.38
2138554-13855477.05477.05
3152772-15277284.96184.96
4155310-15531086.37386.37
5161336-16133689.72489.72
6160225-16022589.10689.11
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1148440-14844082.55285.262.5082.5585.262.50
2151069-15106984.01484.01
3151959-15195984.50984.51
4156879-15687987.24587.25
5152734-15273484.94084.94
6158734-15873488.27788.28
极限1152112-15211284.59484.353.6884.5984.353.68
2151197-15119784.08584.09
3149247-14924783.00183.00
4156817-15681787.21187.21
5142602-14260279.30579.31
6158018-15801887.87987.88
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