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%
114.741885171885121886931885331883331885180.07
214.701886561884381885470.09
单位质量响应值RSD%判断
12789.5512826.330.21数据可信
加速3月-供试品溶液-24050601批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1136762-13676275.47481.633.8175.4781.633.81
2149996-14999682.77882.78
3149550-14955082.53282.53
4151005-15100583.33583.33
5152100-15210083.93983.94
6148129-14812981.74781.75
5min1176515-17651597.41397.381.2097.4197.381.20
2176270-17627097.27897.28
3178290-17829098.39298.39
4173920-17392095.98195.98
5179340-17934098.97298.97
6174434-17443496.26496.26
10min1179330-17933098.96698.821.6598.9798.821.65
2179091-17909198.83498.83
3181319-181319100.064100.06
4174867-17486796.50396.50
5182991-182991100.987100.99
6176752-17675297.54497.54
15min1180406-18040699.56099.231.3799.5699.231.37
2179770-17977099.20999.21
3181431-181431100.126100.13
4176508-17650897.40997.41
5183178-183178101.090101.09
6177584-17758498.00398.00
20min1180134-18013499.41099.651.3399.4199.651.33
2180034-18003499.35599.35
3182229-182229100.566100.57
4180209-18020999.45199.45
5183942-183942101.512101.51
6176870-17687097.60997.61
30min1181312-181312100.06099.261.26100.0699.261.25
2180704-18070499.72599.72
3182065-182065100.476100.48
4177952-17795298.20698.21
5180884-18088499.82499.82
6176266-17626697.27597.28
45min1181874-181874100.370100.021.21100.37100.021.21
2181053-18105399.91799.92
3179846-17984699.25199.25
4178804-17880498.67698.68
5185144-185144102.175102.17
6180734-18073499.74199.74
60min1181692-181692100.270100.430.77100.27100.430.77
2180608-18060899.67299.67
3183351-183351101.185101.19
4181539-181539100.185100.19
5183978-183978101.531101.53
6180730-18073099.73999.74
极限1182240-182240100.572100.490.53100.57100.490.53
2181782-181782100.319100.32
3182153-182153100.524100.52
4180988-18098899.88199.88
5183806-183806101.436101.44
6181582-181582100.209100.21
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%
114.741890161890921888031891621888951889940.08
214.701895191897371896280.09
单位质量响应值RSD%判断
12821.8512899.860.43数据可信
加速3月-供试品溶液-24050602批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1142730-14273078.44473.214.2078.4473.214.20
2131450-13145072.24572.24
3136298-13629874.90974.91
4131639-13163972.34972.35
5130543-13054371.74671.75
6126612-12661269.58669.59
5min1170059-17005993.46493.430.8293.4693.420.82
2167979-16797992.32192.32
3171657-17165794.34394.34
4169275-16927593.03493.03
5171442-17144294.22594.22
6169540-16954093.17993.18
10min1173202-17320295.19294.990.6095.1994.990.60
2173217-17321795.20095.20
3172497-17249794.80494.80
4172062-17206294.56594.57
5174491-17449195.90095.90
6171558-17155894.28894.29
15min1173372-17337295.28595.350.5595.2995.350.55
2172298-17229894.69594.70
3173170-17317095.17495.17
4175027-17502796.19596.19
5174082-17408295.67695.68
6173021-17302195.09295.09
20min1174602-17460295.96195.610.6895.9695.610.68
2173760-17376095.49995.50
3174420-17442095.86195.86
4174964-17496496.16096.16
5174299-17429995.79595.79
6171709-17170994.37194.37
30min1173144-17314495.16095.980.8595.1695.980.84
2174202-17420295.74195.74
3175114-17511496.24396.24
4174854-17485496.10096.10
5177156-17715697.36597.36
6173325-17332595.25995.26
45min1174894-17489496.12296.550.8496.1296.550.84
2173730-17373095.48295.48
3175762-17576296.59996.60
4176588-17658897.05397.05
5177943-17794397.79897.80
6175132-17513296.25396.25
60min1176946-17694697.25096.960.6397.2596.960.63
2175431-17543196.41796.42
3175429-17542996.41696.42
4178132-17813297.90197.90
5176945-17694597.24997.25
6175599-17559996.50996.51
极限1176717-17671797.12497.000.4797.1297.000.47
2175748-17574896.59196.59
3176005-17600596.73296.73
4177824-17782497.73297.73
5176903-17690397.22697.23
6175743-17574396.58896.59
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%
114.741888701888481890081889831888291889080.05
214.701889721887551888640.09
单位质量响应值RSD%判断
12816.0112847.890.18数据可信
加速3月-供试品溶液-24050603批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1137903-13790375.96270.804.5675.9670.804.56
2129829-12982971.51471.51
3131766-13176672.58172.58
4125881-12588169.34069.34
5123689-12368968.13268.13
6122114-12211467.26567.26
5min1170792-17079294.07894.321.1094.0894.321.10
2172967-17296795.27695.28
3171711-17171194.58494.58
4169967-16996793.62493.62
5173459-17345995.54795.55
6168467-16846792.79792.80
10min1173450-17345095.54295.940.5695.5495.940.56
2173885-17388595.78295.78
3174567-17456796.15796.16
4173959-17395995.82395.82
5175919-17591996.90296.90
6173294-17329495.45695.46
15min1172949-17294995.26696.790.9395.2796.790.93
2177916-17791698.00298.00
3175989-17598996.94196.94
4175451-17545196.64496.64
5176432-17643297.18597.18
6175534-17553496.69096.69
20min1174024-17402495.85896.500.8695.8696.500.86
2177726-17772697.89897.90
3174862-17486296.32096.32
4175569-17556996.70996.71
5175522-17552296.68396.68
6173409-17340995.52095.52
30min1174560-17456096.15496.571.9896.1596.571.98
2177999-17799998.04898.05
3177078-17707897.54197.54
4175811-17581196.84396.84
5177684-17768497.87497.87
6168750-16875092.95392.95
45min1174648-17464896.20297.330.9696.2097.330.96
2179237-17923798.73098.73
3176975-17697597.48497.48
4176057-17605796.97896.98
5177870-17787097.97797.98
6175370-17537096.60096.60
60min1175313-17531396.56897.170.9996.5797.170.99
2177389-17738997.71297.71
3176803-17680397.38997.39
4177381-17738197.70797.71
5178102-17810298.10598.10
6173408-17340895.51995.52
极限1175813-17581396.84495.833.1496.8495.823.14
2177988-17798898.04298.04
3176376-17637697.15497.15
4177880-17788097.98297.98
5163794-16379490.22390.22
6171942-17194294.71194.71
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%
114.741885771890221888111886211886731887410.10
214.701884651884581884620.01
单位质量响应值RSD%判断
12804.6812820.540.09数据可信
加速3月-供试品溶液-2024051221批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1137086-13708675.62670.134.3375.6370.144.33
2128467-12846770.87170.87
3127297-12729770.22570.23
4125320-12532069.13569.13
5122746-12274667.71567.71
6121878-12187867.23667.24
5min1168586-16858693.00393.661.1293.0093.661.12
2172618-17261895.22795.23
3170311-17031193.95593.95
4167868-16786892.60792.61
5171151-17115194.41894.42
6168141-16814192.75792.76
10min1173086-17308695.48596.020.7195.4996.020.71
2174816-17481696.44096.44
3175585-17558596.86496.86
4173948-17394895.96195.96
5174694-17469496.37396.37
6172234-17223495.01595.02
15min1172428-17242895.12295.800.7995.1295.800.79
2175993-17599397.08997.09
3174142-17414296.06896.07
4173547-17354795.74095.74
5173649-17364995.79695.80
6172212-17221295.00395.00
20min1172698-17269895.27196.090.8395.2796.090.83
2176627-17662797.43997.44
3174109-17410996.05096.05
4174594-17459496.31796.32
5174313-17431396.16296.16
6172762-17276295.30795.31
30min1174204-17420496.10296.430.6496.1096.430.64
2175989-17598997.08797.09
3175551-17555196.84596.85
4175309-17530996.71296.71
5174772-17477296.41696.42
6172927-17292795.39895.40
45min1174411-17441196.21696.470.7396.2296.480.73
2176093-17609397.14497.14
3176012-17601297.10097.10
4174042-17404296.01396.01
5175736-17573696.94796.95
6172977-17297795.42595.43
60min1174726-17472696.39096.731.0296.3996.731.02
2177515-17751597.92997.93
3176005-17600597.09697.10
4176336-17633697.27897.28
5175138-17513896.61796.62
6172308-17230895.05695.06
极限1176067-17606797.13096.830.6097.1396.840.60
2176551-17655197.39797.40
3173742-17374295.84795.85
4176299-17629997.25897.26
5175629-17562996.88896.89
6174906-17490696.48996.49
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