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%
113.71775131776441777921779321777071777180.09
213.751782821783851783340.05
单位质量响应值RSD%判断
12972.1212969.750.02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%
2min143890-4389023.93424.077.6323.9324.077.63
243924-4392423.95223.95
344706-4470624.37924.38
443084-4308423.49423.49
549849-4984927.18327.18
639397-3939721.48421.48
5min1107722-10772258.74257.234.0058.7457.234.01
2101193-10119355.18255.18
3104952-10495257.23257.23
4103154-10315456.25156.25
5111766-11176660.94760.95
6100884-10088455.01355.01
10min1128098-12809869.85469.183.8969.8569.183.89
2125454-12545468.41268.41
3121177-12117766.07966.08
4124870-12487068.09368.09
5135833-13583374.07274.07
6125742-12574268.56968.57
15min1136750-13675074.57274.743.7174.5774.743.71
2137898-13789875.19875.20
3135689-13568973.99373.99
4136120-13612074.22874.23
5145827-14582779.52179.52
6130073-13007370.93170.93
20min1141319-14131977.06375.543.5977.0675.543.59
2141113-14111376.95176.95
3134499-13449973.34473.34
4134481-13448173.33473.33
5145903-14590379.56379.56
6133872-13387273.00273.00
30min1147606-14760680.49179.023.6980.4979.023.69
2135442-13544273.85873.86
3146047-14604779.64179.64
4144384-14438478.73478.73
5151513-15151382.62282.62
6144431-14443178.76078.76
45min1149800-14980081.68876.455.8581.6976.465.85
2135806-13580674.05774.06
3149291-14929181.41081.41
4134130-13413073.14373.14
5142064-14206477.46977.47
6130124-13012470.95870.96
60min1150202-15020281.90779.263.7681.9179.263.76
2137605-13760575.03875.04
3147392-14739280.37580.37
4148961-14896181.23081.23
5148653-14865381.06281.06
6139221-13922175.91975.92
90min1147621-14762180.50080.861.7780.5080.861.77
2145297-14529779.23279.23
3146097-14609779.66979.67
4151102-15110282.39882.40
5151737-15173782.74482.74
6147870-14787080.63580.64
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1154669-15466984.34382.572.0184.3482.572.01
2147438-14743880.40080.40
3150828-15082882.24882.25
4150599-15059982.12482.12
5155356-15535684.71884.72
6149665-14966581.61481.61
极限1145982-14598279.60676.095.1279.6176.095.12
2142403-14240377.65477.65
3145264-14526479.21479.21
4130017-13001770.90070.90
5142530-14253077.72377.72
6130993-13099371.43271.43
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%
113.71781811779781779761779341780501780240.06
213.751787621788621788120.04
单位质量响应值RSD%判断
12994.4513004.510.06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%
2min161505-6150533.46632.437.1033.4732.437.10
262438-6243833.97333.97
354083-5408329.42729.43
456678-5667830.83930.84
565442-6544235.60835.61
657467-5746731.26931.27
5min1108008-10800858.76960.233.3458.7760.233.34
2110768-11076860.27160.27
3105240-10524057.26357.26
4113751-11375161.89461.89
5115352-11535262.76562.76
6111023-11102360.40960.41
10min1131897-13189771.76771.712.6471.7771.712.64
2133285-13328572.52272.52
3131453-13145371.52671.53
4136586-13658674.31974.32
5131630-13163071.62271.62
6125872-12587268.48968.49
15min1140971-14097176.70576.304.6876.7076.304.68
2137916-13791675.04275.04
3129893-12989370.67770.68
4146207-14620779.55479.55
5148162-14816280.61780.62
6138270-13827075.23575.23
20min1145799-14579979.33278.124.4079.3378.124.41
2145320-14532079.07179.07
3132033-13203371.84171.84
4145196-14519679.00379.00
5150898-15089882.10682.11
6142159-14215977.35177.35
30min1149940-14994081.58580.202.6081.5880.202.60
2152248-15224882.84182.84
3148896-14889681.01781.02
4143707-14370778.19378.19
5147368-14736880.18580.19
6142187-14218777.36677.37
45min1148877-14887781.00680.941.9181.0180.941.91
2151651-15165182.51682.52
3143387-14338778.01978.02
4150169-15016981.70981.71
5148854-14885480.99480.99
6149626-14962681.41481.41
60min1153160-15316083.33781.654.1083.3481.654.10
2150705-15070582.00182.00
3154423-15442384.02484.02
4153347-15334783.43983.44
5137882-13788275.02475.02
6150823-15082382.06582.07
90min1140858-14085876.64379.324.0876.6479.324.09
2151694-15169482.53982.54
3143461-14346178.05978.06
4148967-14896781.05581.06
5151953-15195382.68082.68
6137780-13778074.96874.97
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1149037-14903781.09381.543.4081.0981.543.40
2158419-15841986.19886.20
3151656-15165682.51882.52
4144230-14423078.47878.48
5150412-15041281.84281.84
6145367-14536779.09679.10
极限1148130-14813080.60082.942.8780.6082.942.87
2157769-15776985.84585.84
3147114-14711480.04780.05
4150900-15090082.10782.11
5155953-15595384.85684.86
6154721-15472184.18684.19
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%
113.71788741792201789551791951792871791060.11
213.751778721783181780950.18
单位质量响应值RSD%判断
13073.4312952.360.66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%
2min141936-4193622.79526.9814.6522.7926.9814.66
250267-5026727.32327.32
358017-5801731.53631.54
443267-4326723.51823.52
545815-4581524.90324.90
658540-5854031.82031.82
5min195098-9509851.69255.887.1351.6955.887.14
2102631-10263155.78755.79
3110371-11037159.99459.99
493824-9382451.00051.00
5103678-10367856.35656.36
6111202-11120260.44660.45
10min1115865-11586562.98065.448.4762.9865.448.47
2110729-11072960.18960.19
3134694-13469473.21573.22
4115025-11502562.52462.52
5114091-11409162.01662.02
6131889-13188971.69071.69
15min1120295-12029565.38870.627.3465.3970.627.34
2129385-12938570.32970.33
3141205-14120576.75476.75
4118526-11852664.42764.43
5129998-12999870.66370.66
6140107-14010776.15776.16
20min1140001-14000176.10072.485.3476.1072.485.35
2129978-12997870.65270.65
3133807-13380772.73372.73
4122201-12220166.42466.42
5132279-13227971.90271.90
6141836-14183677.09777.10
30min1128016-12801669.58572.926.0469.5972.926.04
2133886-13388672.77672.78
3144995-14499578.81478.81
4123930-12393067.36467.36
5131973-13197371.73671.74
6142095-14209577.23877.24
45min1139405-13940575.77676.284.1275.7876.284.12
2139093-13909375.60675.61
3148647-14864780.80080.80
4133753-13375372.70472.70
5135488-13548873.64773.65
6145633-14563379.16179.16
60min1129023-12902370.13376.546.5570.1376.546.56
2141791-14179177.07377.07
3148915-14891580.94580.95
4130313-13031370.83470.83
5144077-14407778.31578.32
6150745-15074581.94081.94
90min1150888-15088882.01882.081.2882.0282.081.28
2150983-15098382.06982.07
3153778-15377883.58983.59
4150617-15061781.87081.87
5147859-14785980.37180.37
6151897-15189782.56682.57
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1147276-14727680.05481.462.7080.0581.462.70
2155059-15505984.28584.28
3148919-14891980.94780.95
4146475-14647579.61979.62
5154831-15483184.16184.16
6146600-14660079.68779.69
极限1138128-13812875.08278.424.7475.0878.424.74
2138306-13830675.17875.18
3153068-15306883.20383.20
4139048-13904875.58275.58
5145439-14543979.05679.06
6151629-15162982.42082.42
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