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%
114.871884591880771878871882341880671881450.12
214.861885381882571883980.11
单位质量响应值RSD%判断
12652.6612678.200.15数据可信
加速3月-供试品溶液-24050601批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1106532-10653259.45355.9310.1059.4555.9310.10
298068-9806854.72954.73
3114599-11459963.95563.95
497961-9796154.67054.67
599889-9988955.74655.75
684241-8424147.01347.01
5min1162288-16228890.56989.142.2190.5789.142.21
2163506-16350691.24991.25
3161427-16142790.08990.09
4160301-16030189.46089.46
5156039-15603987.08287.08
6154808-15480886.39586.39
10min1173036-17303696.56795.251.8696.5795.251.86
2174637-17463797.46197.46
3170591-17059195.20395.20
4171719-17171995.83295.83
5166311-16631192.81492.81
6167741-16774193.61293.61
15min1174506-17450697.38896.471.9197.3996.481.91
2177568-17756899.09699.10
3172892-17289296.48796.49
4173978-17397897.09397.09
5168712-16871294.15494.15
6169562-16956294.62894.63
20min1175142-17514297.74397.071.9197.7497.071.91
2178904-17890499.84299.84
3174125-17412597.17597.17
4174910-17491097.61397.61
5169585-16958594.64194.64
6170975-17097595.41795.42
30min1175926-17592698.18097.091.5898.1897.091.58
2175764-17576498.09098.09
3175474-17547497.92897.93
4175669-17566998.03798.04
5169725-16972594.71994.72
6171284-17128495.58995.59
45min1176039-17603998.24397.742.0798.2497.742.07
2180833-180833100.919100.92
3175733-17573398.07298.07
4175463-17546397.92297.92
5170081-17008194.91894.92
6172718-17271896.39096.39
60min1175371-17537197.87097.682.0597.8797.682.05
2180726-180726100.859100.86
3175614-17561498.00698.01
4175749-17574998.08198.08
5169986-16998694.86594.87
6172766-17276696.41796.42
极限1175857-17585798.14297.511.6998.1497.501.69
2178185-17818599.44199.44
3176057-17605798.25398.25
4175662-17566298.03398.03
5169979-16997994.86194.86
6172562-17256296.30396.30
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%
114.871882571879741878531880721879611880230.09
214.861890711890441890580.02
单位质量响应值RSD%判断
12644.4512722.610.44数据可信
加速3月-供试品溶液-24050602批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1114843-11484364.00063.982.6664.0063.982.66
2110386-11038661.51661.52
3118467-11846766.02066.02
4113347-11334763.16663.17
5118027-11802765.77565.77
6113745-11374563.38863.39
5min1164338-16433891.58391.460.6791.5891.460.66
2163589-16358991.16691.17
3163355-16335591.03591.04
4165740-16574092.36492.36
5164886-16488691.88891.89
6162798-16279890.72590.72
10min1172479-17247996.12096.030.9796.1296.030.97
2174775-17477597.39997.40
3170004-17000494.74194.74
4172863-17286396.33496.33
5172879-17287996.34396.34
6170941-17094195.26395.26
15min1174701-17470197.35896.931.2397.3696.931.23
2177092-17709298.69198.69
3171299-17129995.46295.46
4174127-17412797.03897.04
5174563-17456397.28197.28
6171777-17177795.72995.73
20min1174832-17483297.43197.460.7997.4397.460.79
2176906-17690698.58798.59
3172705-17270596.24696.25
4174854-17485497.44397.44
5175526-17552697.81897.82
6174498-17449897.24597.24
30min1174313-17431397.14297.560.9597.1497.560.95
2178015-17801599.20599.20
3173076-17307696.45396.45
4174981-17498197.51497.51
5175489-17548997.79797.80
6174472-17447297.23097.23
45min1175650-17565097.88797.931.0597.8997.941.05
2178889-17888999.69299.69
3173427-17342796.64896.65
4175731-17573197.93297.93
5176192-17619298.18998.19
6174525-17452597.26097.26
60min1175710-17571097.92097.750.7397.9297.750.73
2177203-17720398.75298.75
3173782-17378296.84696.85
4175127-17512797.59597.60
5176336-17633698.26998.27
6174268-17426897.11797.12
极限1175832-17583297.98897.891.1897.9997.891.18
2179011-17901199.76099.76
3173451-17345196.66196.66
4175970-17597098.06598.07
5176190-17619098.18898.19
6173469-17346996.67296.67
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%
114.871886981884331887231885661888721886580.09
214.861877821879891878860.08
单位质量响应值RSD%判断
12687.1612643.740.25数据可信
加速3月-供试品溶液-24050603批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1111740-11174062.35962.543.6962.3662.543.69
2105756-10575659.02059.02
3117479-11747965.56265.56
4110411-11041161.61861.62
5115674-11567464.55564.55
6111360-11136062.14762.15
5min1166354-16635492.83893.420.8892.8493.430.88
2168587-16858794.08494.08
3167961-16796193.73593.74
4166062-16606292.67592.68
5169455-16945594.56994.57
6166014-16601492.64892.65
10min1174651-17465197.46998.540.8597.4798.540.85
2178007-17800799.34199.34
3176679-17667998.60098.60
4176424-17642498.45898.46
5178469-17846999.59999.60
6175228-17522897.79197.79
15min1175673-17567398.03999.150.9298.0499.150.92
2180022-180022100.466100.47
3177664-17766499.15099.15
4177658-17765899.14799.15
5178821-17882199.79699.80
6176166-17616698.31498.31
20min1176727-17672798.62799.350.7298.6399.350.72
2180334-180334100.640100.64
3178285-17828599.49799.50
4177597-17759799.11399.11
5178008-17800899.34299.34
6177139-17713998.85798.86
30min1176847-17684798.69499.890.7698.6999.890.76
2180857-180857100.932100.93
3178686-17868699.72099.72
4178896-17889699.83899.84
5179937-179937100.419100.42
6178738-17873899.74999.75
45min1177542-17754299.08299.970.7299.0899.970.72
2180715-180715100.853100.85
3178909-17890999.84599.84
4178908-17890899.84499.84
5180587-180587100.781100.78
6178165-17816599.43099.43
60min1176751-17675198.64199.960.8998.6499.960.89
2180872-180872100.940100.94
3178962-17896299.87499.87
4178914-17891499.84899.85
5180926-180926100.970100.97
6178317-17831799.51499.51
极限1177637-17763799.135100.070.7699.13100.070.76
2181200-181200101.123101.12
3178190-17819099.44499.44
4179046-17904699.92199.92
5180523-180523100.746100.75
6179306-179306100.066100.07
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%
114.871892801890581891721892661890971891750.06
214.861896771896151896460.03
单位质量响应值RSD%判断
12721.9212762.180.23数据可信
加速3月-供试品溶液-2024051221批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min198074-9807454.40458.935.6254.4058.935.62
2114093-11409363.29063.29
3112276-11227662.28262.28
4104790-10479058.12958.13
5104976-10497658.23258.23
6103220-10322057.25857.26
5min1166219-16621992.20593.050.8192.2193.050.81
2169499-16949994.02594.02
3167979-16797993.18193.18
4168192-16819293.30093.30
5168534-16853493.48993.49
6166029-16602992.10092.10
10min1175228-17522897.20397.490.5897.2097.500.58
2176467-17646797.89097.89
3174830-17483096.98296.98
4177019-17701998.19698.20
5176426-17642697.86797.87
6174558-17455896.83196.83
15min1176138-17613897.70797.990.5397.7197.990.53
2177657-17765798.55098.55
3175584-17558497.40097.40
4177763-17776398.60998.61
5176842-17684298.09898.10
6175867-17586797.55797.56
20min1176299-17629997.79798.050.4697.8098.050.46
2177690-17769098.56898.57
3175846-17584697.54597.55
4177588-17758898.51298.51
5177101-17710198.24298.24
6176003-17600397.63397.63
30min1176469-17646997.89198.270.5697.8998.270.56
2177585-17758598.51098.51
3175607-17560797.41397.41
4178008-17800898.74598.74
5178168-17816898.83398.83
6177059-17705998.21898.22
45min1176626-17662697.97898.470.7997.9898.470.79
2179525-17952599.58699.59
3175926-17592697.59097.59
4178796-17879699.18299.18
5177452-17745298.43698.44
6176729-17672998.03598.04
60min1176165-17616597.72298.240.7197.7298.240.71
2177814-17781498.63798.64
3175534-17553497.37297.37
4178741-17874199.15199.15
5177962-17796298.71998.72
6176365-17636597.83397.83
极限1175973-17597397.61698.120.6597.6298.120.65
2177836-17783698.64998.65
3175509-17550997.35897.36
4178558-17855899.05099.05
5176658-17665897.99698.00
6176759-17675998.05298.05
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%
114.871882541883691884231885321884751884110.06
214.861876521878031877280.06
单位质量响应值RSD%判断
12670.5412633.110.21数据可信
加速3月-供试品溶液-2763566批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min119958-1995811.15011.5912.9911.1511.5913.00
223840-2384013.31913.32
317926-1792610.01510.01
421504-2150412.01412.01
517684-176849.8809.88
623609-2360913.19013.19
5min194998-9499853.07362.8210.6553.0762.8210.65
2104759-10475958.52658.53
3118087-11808765.97265.97
4114049-11404963.71763.72
5112531-11253162.86862.87
6130285-13028572.78772.79
10min1133465-13346574.56485.017.8374.5685.017.83
2145248-14524881.14781.15
3161611-16161190.28890.29
4155981-15598187.14387.14
5150236-15023683.93383.93
6166428-16642892.97992.98
15min1150047-15004783.82891.625.9783.8391.625.97
2157660-15766088.08188.08
3172587-17258796.42096.42
4167348-16734893.49393.49
5160280-16028089.54589.54
6176032-17603298.34598.34
20min1160171-16017189.48494.504.1089.4894.504.10
2164406-16440691.85091.85
3175271-17527197.92097.92
4171949-17194996.06496.06
5165201-16520192.29492.29
6177858-17785899.36599.37
30min1166363-16636392.94396.623.0592.9496.623.05
2170371-17037195.18295.18
3176918-17691898.84098.84
4174588-17458897.53897.54
5169075-16907594.45894.46
6180347-180347100.756100.76
45min1171994-17199496.08997.661.9796.0997.661.97
2172021-17202196.10496.10
3177155-17715598.97298.97
4175780-17578098.20498.20
5171815-17181595.98995.99
6180110-180110100.623100.62
60min1173451-17345196.90398.341.8496.9098.341.84
2174302-17430297.37897.38
3177569-17756999.20499.20
4177234-17723499.01699.02
5172417-17241796.32596.33
6181117-181117101.186101.19
极限1178299-17829999.61199.470.7099.6199.470.70
2179288-179288100.164100.16
3177329-17732999.07099.07
4177130-17713098.95898.96
5176579-17657998.65198.65
6179612-179612100.345100.35
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