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D382/2305001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(%)99.83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%
114.501863681866791865201863341866571865120.09
214.521864951866671865810.07
单位质量响应值RSD%判断
12862.9012849.930.08数据可信
供试品溶液-24050601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%
2min156439-5643931.02931.392.6631.0331.382.66
259123-5912332.50532.50
355030-5503030.25530.25
457961-5796131.86631.87
557970-5797031.87131.87
656007-5600730.79230.79
5min1106678-10667858.65058.162.7758.6558.162.76
2109537-10953760.22260.22
3101943-10194356.04756.05
4108413-10841359.60459.60
5103829-10382957.08457.08
6104278-10427857.33057.33
10min1125282-12528268.87868.201.9768.8868.201.97
2126825-12682569.72769.73
3121241-12124166.65766.66
4126478-12647869.53669.54
5122378-12237867.28267.28
6122076-12207667.11667.12
15min1134559-13455973.97973.522.8973.9873.522.89
2138974-13897476.40676.41
3129216-12921671.04171.04
4137061-13706175.35475.35
5132392-13239272.78772.79
6130158-13015871.55971.56
20min1139210-13921076.53676.472.6976.5476.472.69
2144625-14462579.51379.51
3136458-13645875.02375.02
4142004-14200478.07278.07
5137878-13787875.80375.80
6134354-13435473.86673.87
30min1143800-14380079.05978.871.8879.0678.871.88
2147601-14760181.14981.15
3140847-14084777.43677.44
4144815-14481579.61779.62
5143411-14341178.84578.85
6140241-14024177.10277.10
45min1147909-14790981.31881.271.2681.3281.271.26
2150028-15002882.48382.48
3146061-14606180.30280.30
4150068-15006882.50582.51
5146728-14672880.66980.67
6146128-14612880.33980.34
60min1148558-14855881.67582.492.4781.6782.492.47
2153870-15387084.59584.60
3145070-14507079.75779.76
4154932-15493285.17985.18
5149186-14918682.02082.02
6148599-14859981.69881.70
90min1154117-15411784.73183.741.8584.7383.741.85
2153191-15319184.22284.22
3148851-14885181.83681.84
4156300-15630085.93185.93
5151838-15183883.47883.48
6149605-14960582.25182.25
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1152315-15231583.74184.562.4883.7484.562.48
2158278-15827887.01987.02
3150634-15063482.81682.82
4158851-15885187.33487.33
5152600-15260083.89783.90
6150166-15016682.55982.56
极限1155678-15567885.58985.281.4685.5985.281.46
2159185-15918587.51887.52
3154596-15459684.99584.99
4154279-15427984.82084.82
5154626-15462685.01185.01
6152380-15238083.77683.78
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D382/2305001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(%)99.83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%
114.501866741863281864951860131864981864020.14
214.521866611861671864140.19
单位质量响应值RSD%判断
12855.3112838.430.10数据可信
供试品溶液-24050601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%
2min156471-5647131.07032.159.4531.0732.159.45
257258-5725831.50331.50
368611-6861137.74937.75
451903-5190328.55728.56
557643-5764331.71531.71
658702-5870232.29732.30
5min1102470-10247056.37856.591.6156.3856.591.61
2103715-10371557.06357.06
3104160-10416057.30857.31
499743-9974354.87854.88
5103022-10302256.68256.68
6103978-10397857.20857.21
10min1122433-12243367.36267.642.0067.3667.642.00
2122559-12255967.43167.43
3126901-12690169.82069.82
4119392-11939265.68965.69
5122342-12234267.31267.31
6124010-12401068.23068.23
15min1130410-13041071.75171.782.4571.7571.782.45
2131269-13126972.22372.22
3135885-13588574.76374.76
4128229-12822970.55170.55
5130533-13053371.81871.82
6126488-12648869.59369.59
20min1137276-13727675.52875.262.6775.5375.262.67
2135819-13581974.72774.73
3140355-14035577.22277.22
4130045-13004571.55071.55
5138254-13825476.06676.07
6138994-13899476.47476.47
30min1142825-14282578.58178.542.5178.5878.542.51
2144374-14437479.43479.43
3145907-14590780.27780.28
4135876-13587674.75874.76
5142767-14276778.54978.55
6144764-14476479.64879.65
45min1148030-14803081.44580.182.4381.4580.182.43
2145978-14597880.31680.32
3145914-14591480.28180.28
4138946-13894676.44776.45
5146615-14661580.66780.67
6148917-14891781.93381.93
60min1149352-14935282.17382.591.1382.1782.591.13
2151307-15130783.24883.25
3152778-15277884.05784.06
4148106-14810681.48781.49
5150056-15005682.56082.56
6149068-14906882.01682.02
90min1149654-14965482.33983.120.9882.3483.120.98
2152345-15234583.81983.82
3149123-14912382.04782.05
4150972-15097283.06483.06
5151506-15150683.35883.36
6152855-15285584.10084.10
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1150903-15090383.02683.611.4683.0383.621.46
2153139-15313984.25684.26
3153629-15362984.52684.53
4148602-14860281.76081.76
5154606-15460685.06385.06
6150956-15095683.05583.06
极限1155232-15523285.40885.460.5085.4185.460.50
2155822-15582285.73285.73
3154918-15491885.23585.23
4154155-15415584.81584.82
5155373-15537385.48585.49
6156421-15642186.06286.06
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