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%
113.781740881740601738871741151737321739760.10
213.831742191742801742500.03
单位质量响应值RSD%判断
12625.2512599.420.15数据可信
加速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%
2min156997-5699731.96526.8419.9731.9626.8419.96
249289-4928927.64227.64
338403-3840321.53721.54
433843-3384318.98018.98
553400-5340029.94829.95
655230-5523030.97430.97
5min1108536-10853660.86961.852.1460.8761.852.15
2108841-10884161.04061.04
3111030-11103062.26862.27
4111828-11182862.71562.72
5107612-10761260.35160.35
6113835-11383563.84163.84
10min1117128-11712865.68868.977.1765.6968.977.17
2111641-11164162.61062.61
3126613-12661371.00771.01
4134530-13453075.44775.45
5130179-13017973.00773.01
6117766-11776666.04566.05
15min1126771-12677171.09574.474.4271.1074.474.42
2130436-13043673.15173.15
3134133-13413375.22475.22
4140539-14053978.81778.82
5126571-12657170.98370.98
6138250-13825077.53377.53
20min1126599-12659970.99972.653.5871.0072.653.58
2128351-12835171.98271.98
3133603-13360374.92774.93
4128723-12872372.19072.19
5123688-12368869.36669.37
6136299-13629976.43976.44
30min1134899-13489975.65476.053.3175.6576.053.31
2136421-13642176.50776.51
3138470-13847077.65677.66
4127877-12787771.71671.72
5141174-14117479.17379.17
6134808-13480875.60375.60
45min1134249-13424975.28977.372.7275.2977.372.72
2135058-13505875.74375.74
3134703-13470375.54475.54
4142707-14270780.03380.03
5141412-14141279.30679.31
6139651-13965178.31978.32
60min1141286-14128679.23678.711.4179.2478.711.41
2141655-14165579.44379.44
3141708-14170879.47279.47
4137400-13740077.05677.06
5141739-14173979.49079.49
6138271-13827177.54577.54
90min1139649-13964978.31877.212.2178.3277.212.20
2138237-13823777.52677.53
3135722-13572276.11576.12
4133675-13367574.96774.97
5142209-14220979.75379.75
6136539-13653976.57476.57
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1137226-13722676.95978.193.9776.9678.193.97
2142452-14245279.89079.89
3145769-14576981.75081.75
4130384-13038473.12273.12
5143087-14308780.24680.25
6137580-13758077.15777.16
极限1123635-12363569.33775.876.5869.3475.886.58
2127610-12761071.56671.57
3137301-13730177.00177.00
4133802-13380275.03975.04
5147634-14763482.79682.80
6141770-14177079.50779.51
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%
113.781744681743291744221743671744071743990.04
213.831744021741001742510.13
单位质量响应值RSD%判断
12655.9512599.490.32数据可信
加速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%
2min160126-6012633.67934.3615.6033.6834.3615.60
256708-5670831.76431.76
359774-5977433.48233.48
456363-5636331.57131.57
580408-8040845.03945.04
654715-5471530.64830.65
5min1122530-12253068.63467.013.9068.6367.013.90
2116198-11619865.08765.09
3122547-12254768.64368.64
4116578-11657865.30065.30
5125918-12591870.53170.53
6114060-11406063.88963.89
10min1138955-13895577.83476.602.5477.8376.602.54
2141491-14149179.25479.25
3138417-13841777.53277.53
4135821-13582176.07876.08
5132867-13286774.42474.42
6132996-13299674.49674.50
15min1137359-13735976.94077.083.2676.9477.083.26
2138458-13845877.55577.56
3130934-13093473.34173.34
4134398-13439875.28175.28
5143013-14301380.10780.11
6141530-14153079.27679.28
20min1141697-14169779.37078.252.3379.3778.252.33
2144031-14403180.67780.68
3141300-14130079.14779.15
4138514-13851477.58777.59
5137605-13760577.07877.08
6135039-13503975.64075.64
30min1140960-14096078.95781.012.2778.9681.022.27
2145787-14578781.66181.66
3141478-14147879.24779.25
4143195-14319580.20980.21
5149041-14904183.48383.48
6147338-14733882.52982.53
45min1148088-14808882.95083.261.2782.9583.261.27
2150725-15072584.42784.43
3149090-14909083.51183.51
4145226-14522681.34681.35
5149593-14959383.79383.79
6149116-14911683.52583.53
60min1143753-14375380.52179.642.9180.5279.642.91
2146037-14603781.80181.80
3142187-14218779.64479.64
4140957-14095778.95578.96
5145458-14545881.47681.48
6134701-13470175.45175.45
90min1145551-14555181.52981.501.1881.5381.501.18
2147868-14786882.82682.83
3145216-14521681.34181.34
4145168-14516881.31481.31
5146479-14647982.04882.05
6142714-14271479.93979.94
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1149541-14954183.76381.263.9183.7681.263.91
2144648-14464881.02381.02
3148461-14846183.15983.16
4135315-13531575.79575.79
5150170-15017084.11684.12
6142282-14228279.69779.70
极限1152654-15265485.50777.449.4085.5177.449.40
2146256-14625681.92381.92
3150636-15063684.37784.38
4127648-12764871.50071.50
5128703-12870372.09172.09
6123597-12359769.23169.23
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%
113.781746821747901749701746111747681747640.08
213.831746391744321745360.09
单位质量响应值RSD%判断
12682.4412620.100.35数据可信
加速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%
2min137788-3778821.12721.796.9921.1321.796.98
236541-3654120.43020.43
338127-3812721.31721.32
438151-3815121.33021.33
538964-3896421.78521.78
644294-4429424.76524.76
5min1116757-11675765.27863.492.2365.2863.502.23
2114543-11454364.04064.04
3111940-11194062.58562.59
4114478-11447864.00464.00
5114213-11421363.85663.86
6109460-10946061.19961.20
10min1138731-13873177.56477.672.0777.5677.672.07
2133772-13377274.79174.79
3140777-14077778.70878.71
4139140-13914077.79277.79
5142229-14222979.52079.52
6138917-13891777.66877.67
15min1148781-14878183.18382.081.9083.1882.081.90
2141484-14148479.10379.10
3148896-14889683.24783.25
4147634-14763482.54182.54
5146295-14629581.79381.79
6147803-14780382.63682.64
20min1150675-15067584.24283.991.4184.2483.991.41
2147059-14705982.22082.22
3150922-15092284.38084.38
4152507-15250785.26685.27
5148307-14830782.91882.92
6151866-15186684.90884.91
30min1154259-15425986.24585.841.8186.2585.841.81
2154635-15463586.45686.46
3155388-15538886.87786.88
4155889-15588987.15787.16
5152650-15265085.34685.35
6148362-14836282.94882.95
45min1149795-14979583.75085.252.4783.7585.252.47
2151713-15171384.82284.82
3155660-15566087.02987.03
4154475-15447586.36686.37
5146774-14677482.06182.06
6156490-15649087.49387.49
60min1155146-15514686.74185.902.9286.7485.902.92
2155563-15556386.97586.97
3157173-15717387.87587.87
4151373-15137384.63284.63
5145556-14555681.38081.38
6157051-15705187.80687.81
90min1153115-15311585.60686.821.2585.6186.821.25
2155679-15567987.03987.04
3156580-15658087.54387.54
4156763-15676387.64587.65
5152594-15259485.31585.31
6156941-15694187.74587.74
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1155808-15580887.11186.631.1187.1186.631.11
2154756-15475686.52386.52
3155052-15505286.68986.69
4155623-15562387.00887.01
5151730-15173084.83184.83
6156718-15671887.62087.62
极限1149325-14932583.48785.712.8083.4985.712.80
2157079-15707987.82287.82
3157973-15797388.32288.32
4152106-15210685.04285.04
5147584-14758482.51382.51
6155759-15575987.08487.08
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