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%
114.871815741813681815141814171814071814560.05
214.861811551812581812060.05
单位质量响应值RSD%判断
12202.8212194.210.05数据可信
加速3月-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%
2min140540-4054023.49024.917.3223.4924.917.31
238132-3813222.09522.10
342916-4291624.86724.87
444407-4440725.73125.73
545925-4592526.61126.61
646021-4602126.66626.67
5min196321-9632155.81255.143.8955.8155.143.88
296517-9651755.92555.93
389235-8923551.70651.71
492753-9275353.74453.74
596199-9619955.74155.74
699957-9995757.91957.92
10min1116166-11616667.31166.493.6267.3166.493.62
2115981-11598167.20467.20
3114082-11408266.10366.10
4108968-10896863.14063.14
5112124-11212464.96964.97
6121207-12120770.23270.23
15min1124207-12420771.97071.473.4271.9771.473.43
2122911-12291171.21971.22
3123727-12372771.69271.69
4118934-11893468.91568.91
5119582-11958269.29069.29
6130705-13070575.73575.74
20min1129128-12912874.82172.632.1874.8272.622.18
2124992-12499272.42572.42
3125079-12507972.47572.48
4121825-12182570.59070.59
5123224-12322471.40071.40
6127780-12778074.04074.04
30min1130711-13071175.73976.053.8775.7476.053.87
2130538-13053875.63875.64
3129238-12923874.88574.89
4128217-12821774.29474.29
5127521-12752173.89073.89
6141273-14127381.85981.86
45min1136611-13661179.15777.684.0979.1677.684.08
2136756-13675679.24179.24
3127375-12737573.80673.81
4129971-12997175.31075.31
5131364-13136476.11776.12
6142265-14226582.43482.43
60min1139423-13942380.78779.152.7280.7979.142.73
2137345-13734579.58379.58
3137572-13757279.71479.71
4135738-13573878.65278.65
5129651-12965175.12475.12
6139822-13982281.01881.02
90min1142389-14238982.50581.533.2482.5181.533.24
2140269-14026981.27781.28
3137698-13769879.78779.79
4138611-13861180.31680.32
5136328-13632878.99378.99
6148932-14893286.29786.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1142506-14250682.57381.682.7782.5781.682.77
2142599-14259982.62782.63
3137927-13792779.92079.92
4136229-13622978.93678.94
5139466-13946680.81280.81
6147054-14705485.20885.21
极限1144318-14431883.62381.753.0483.6281.753.04
2138531-13853180.27080.27
3138050-13805079.99179.99
4140282-14028281.28481.28
5137200-13720079.49979.50
6148147-14814785.84285.84
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%
114.871819401820331822781816081814541818630.19
214.861818461818031818240.02
单位质量响应值RSD%判断
12230.2012235.800.04数据可信
加速3月-供试品溶液-24050602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%
2min158716-5871633.92634.743.2833.9334.743.27
261870-6187035.74935.75
360187-6018734.77634.78
462700-6270036.22836.23
559865-5986534.59034.59
657367-5736733.14733.15
5min1106490-10649061.53060.512.3461.5360.512.35
2107507-10750762.11862.12
3104876-10487660.59860.60
4105621-10562161.02861.03
5100767-10076758.22358.22
6103104-10310459.57459.57
10min1125872-12587272.72972.392.1972.7372.402.19
2129036-12903674.55774.56
3125610-12561072.57872.58
4125696-12569672.62872.63
5120538-12053869.64769.65
6124983-12498372.21672.22
15min1135691-13569178.40377.072.6078.4077.072.59
2138112-13811279.80279.80
3131464-13146475.96075.96
4133638-13363877.21677.22
5128067-12806773.99874.00
6133312-13331277.02877.03
20min1138547-13854780.05379.331.6480.0579.321.64
2138120-13812079.80679.81
3139450-13945080.57580.57
4135989-13598978.57578.57
5133347-13334777.04877.05
6138275-13827579.89679.90
30min1140678-14067881.28482.263.1981.2882.263.19
2148040-14804085.53885.54
3142020-14202082.06082.06
4145210-14521083.90383.90
5134748-13474877.85877.86
6143514-14351482.92382.92
45min1148946-14894686.06185.631.3086.0685.621.29
2150282-15028286.83386.83
3149540-14954086.40586.40
4146957-14695784.91284.91
5145032-14503283.80083.80
6148391-14839185.74185.74
60min1152457-15245788.09087.301.8488.0987.301.84
2152989-15298988.39888.40
3147531-14753185.24485.24
4152619-15261988.18488.18
5147528-14752885.24285.24
6153373-15337388.61988.62
90min1154881-15488189.49189.161.2889.4989.161.28
2156449-15644990.39790.40
3156251-15625190.28290.28
4153432-15343288.65388.65
5151236-15123687.38587.38
6153632-15363288.76988.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1155796-15579690.01989.262.9390.0289.262.93
2159144-15914491.95491.95
3157326-15732690.90390.90
4153008-15300888.40888.41
5146242-14624284.49984.50
6155346-15534689.75989.76
极限1148097-14809785.57188.842.3785.5788.842.37
2158147-15814791.37891.38
3154708-15470889.39189.39
4156448-15644890.39690.40
5151190-15119087.35887.36
6153912-15391288.93188.93
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%
114.871820901819161816881819701818381819000.09
214.861838241839421838830.05
单位质量响应值RSD%判断
12232.6812374.360.82数据可信
加速3月-供试品溶液-24050603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%
2min152633-5263330.23830.715.2330.2430.725.22
253846-5384630.93530.94
349445-4944528.40728.41
454519-5451931.32231.32
557909-5790933.26933.27
652409-5240930.11030.11
5min1100785-10078557.90255.272.7257.9055.272.71
295816-9581655.04755.05
394265-9426554.15654.16
494375-9437554.21954.22
594306-9430654.18054.18
697691-9769156.12456.12
10min1122419-12241970.33169.661.7570.3369.661.75
2121311-12131169.69469.69
3119832-11983268.84568.84
4124839-12483971.72171.72
5119064-11906468.40368.40
6120074-12007468.98468.98
15min1132868-13286876.33475.261.5776.3375.261.57
2131173-13117375.36075.36
3128689-12868973.93373.93
4133913-13391376.93476.93
5129564-12956474.43674.44
6129740-12974074.53774.54
20min1137979-13797979.27078.251.1379.2778.251.13
2137254-13725478.85478.85
3134719-13471977.39777.40
4136642-13664278.50278.50
5133994-13399476.98176.98
6136616-13661678.48778.49
30min1146592-14659284.21982.841.6084.2282.841.60
2142563-14256381.90481.90
3142088-14208881.63181.63
4147065-14706584.49084.49
5141968-14196881.56281.56
6144888-14488883.24083.24
45min1151119-15111986.81985.582.8086.8285.582.80
2150717-15071786.58886.59
3147395-14739584.68084.68
4152689-15268987.72187.72
5141235-14123581.14181.14
6150581-15058186.51086.51
60min1152420-15242087.56787.441.2987.5787.441.28
2152691-15269187.72387.72
3150108-15010886.23986.24
4153756-15375688.33488.33
5149689-14968985.99886.00
6154566-15456688.80088.80
90min1156693-15669390.02289.561.0590.0289.561.05
2154853-15485388.96588.96
3154838-15483888.95688.96
4158459-15845991.03691.04
5154002-15400288.47688.48
6156522-15652289.92389.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158459-15845991.03690.081.2591.0490.081.26
2158004-15800490.77590.77
3153578-15357888.23288.23
4158208-15820890.89290.89
5155249-15524989.19289.19
6157258-15725890.34690.35
极限1159195-15919591.45991.041.0291.4691.041.03
2159210-15921091.46891.47
3157402-15740290.42990.43
4160676-16067692.31092.31
5156035-15603589.64489.64
6158300-15830090.94590.94
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%
114.871830691830791831301831641831201831120.03
214.861833721833831833780.01
单位质量响应值RSD%判断
12314.1912340.380.16数据可信
加速3月-供试品溶液-2024051221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%
2min168025-6802539.00438.142.4339.0038.142.43
264431-6443136.94436.94
366541-6654138.15438.15
468752-6875239.42139.42
565879-6587937.77437.77
665508-6550837.56137.56
5min1116488-11648866.79263.882.9366.7963.882.94
2112133-11213364.29564.30
3107144-10714461.43561.43
4109777-10977762.94462.94
5113199-11319964.90764.91
6109713-10971362.90862.91
10min1131390-13139075.33776.221.7375.3476.221.74
2135730-13573077.82577.83
3133113-13311376.32576.32
4129240-12924074.10474.10
5134091-13409176.88676.89
6134028-13402876.85076.85
15min1144755-14475583.00081.531.9783.0081.531.97
2137611-13761178.90478.90
3140773-14077380.71780.72
4141414-14141481.08581.08
5144118-14411882.63582.64
6144456-14445682.82982.83
20min1150710-15071086.41585.142.1886.4185.142.18
2151188-15118886.68986.69
3148660-14866085.23985.24
4142432-14243281.66881.67
5150163-15016386.10186.10
6147818-14781884.75784.76
30min1154491-15449188.58387.371.6488.5887.381.64
2152392-15239287.37987.38
3153459-15345987.99187.99
4152161-15216187.24787.25
5147660-14766084.66684.67
6154140-15414088.38188.38
45min1159134-15913491.24589.901.9491.2489.901.94
2159815-15981591.63591.64
3157033-15703390.04090.04
4154285-15428588.46588.46
5158402-15840290.82590.83
6152038-15203887.17687.18
60min1159364-15936491.37790.091.6791.3890.091.67
2153047-15304787.75587.75
3156082-15608289.49589.49
4155865-15586589.37189.37
5158412-15841290.83190.83
6159989-15998991.73591.74
90min1161225-16122592.44490.641.7592.4490.641.75
2159949-15994991.71291.71
3155248-15524889.01789.02
4154274-15427488.45888.46
5158297-15829790.76590.77
6159507-15950791.45991.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158600-15860090.93991.381.1790.9491.381.16
2161641-16164192.68292.68
3159830-15983091.64491.64
4156226-15622689.57889.58
5160504-16050492.03092.03
6159451-15945191.42791.43
极限1159871-15987191.66891.042.1091.6791.042.10
2162655-16265593.26493.26
3160502-16050292.02992.03
4153566-15356688.05288.05
5156021-15602189.46089.46
6160029-16002991.75891.76
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