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%
114.501859981862541854371861511860471859770.18
214.521863451861771862610.07
单位质量响应值RSD%判断
12826.0012827.890.02数据可信
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%
2min162290-6229034.32532.913.0634.3232.913.06
258400-5840032.18132.18
359552-5955232.81632.82
457130-5713031.48131.48
560916-6091633.56833.57
660069-6006933.10133.10
5min1113314-11331462.44162.881.3262.4462.881.32
2114066-11406662.85662.86
3113459-11345962.52162.52
4116980-11698064.46264.46
5114139-11413962.89662.90
6112716-11271662.11262.11
10min1137407-13740775.71874.960.9175.7274.960.91
2135465-13546574.64874.65
3136938-13693875.45975.46
4135378-13537874.60074.60
5136857-13685775.41575.41
6134165-13416573.93173.93
15min1140358-14035877.34478.852.3177.3478.852.31
2140575-14057577.46477.46
3143223-14322378.92378.92
4144167-14416779.44379.44
5149076-14907682.14882.15
6141189-14118977.80277.80
20min1148562-14856281.86581.011.8381.8681.011.82
2147755-14775581.42081.42
3144537-14453779.64779.65
4149521-14952182.39382.39
5148837-14883782.01682.02
6142877-14287778.73278.73
30min1144327-14432779.53183.202.3079.5383.202.30
2153398-15339884.53084.53
3151133-15113383.28283.28
4150959-15095983.18683.19
5153864-15386484.78684.79
6152173-15217383.85583.85
45min1145420-14542080.13383.452.3080.1383.442.31
2152628-15262884.10584.11
3149588-14958882.43082.43
4152075-15207583.80183.80
5155214-15521485.53085.53
6153657-15365784.67284.67
60min1155201-15520185.52385.531.3585.5285.531.35
2155639-15563985.76585.76
3151402-15140283.43083.43
4157698-15769886.89986.90
5155153-15515385.49785.50
6156167-15616786.05686.06
90min1154427-15442785.09785.670.7285.1085.660.72
2155747-15574785.82485.82
3155683-15568385.78985.79
4157053-15705386.54486.54
5155885-15588585.90085.90
6153957-15395784.83884.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1156382-15638286.17485.621.7986.1785.611.79
2156416-15641686.19386.19
3154419-15441985.09285.09
4157048-15704886.54186.54
5150187-15018782.76082.76
6157759-15775986.93386.93
极限1156218-15621886.08485.441.7986.0885.441.79
2156006-15600685.96785.97
3149592-14959282.43282.43
4156817-15681786.41486.41
5156810-15681086.41086.41
6154814-15481485.31085.31
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%
114.501862341862531861571860071858071860920.11
214.521858551855981857260.10
单位质量响应值RSD%判断
12833.9312791.050.24数据可信
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%
2min165056-6505635.89034.376.5235.8934.376.52
256178-5617830.99230.99
364501-6450135.58335.58
467094-6709437.01437.01
559294-5929432.71132.71
661662-6166234.01734.02
5min1112936-11293662.30462.372.1162.3062.382.11
2111418-11141861.46661.47
3117623-11762364.88964.89
4113344-11334462.52962.53
5111591-11159161.56261.56
6111472-11147261.49661.50
10min1135442-13544274.71973.214.0774.7273.214.07
2133006-13300673.37673.38
3138433-13843376.37076.37
4132923-13292373.33073.33
5122536-12253667.60067.60
6133862-13386273.84873.85
15min1140675-14067577.60678.371.8377.6178.371.83
2140194-14019477.34177.34
3147083-14708381.14181.14
4140376-14037677.44177.44
5141767-14176778.20978.21
6142280-14228078.49278.49
20min1147094-14709481.14881.031.5081.1581.031.50
2144260-14426079.58479.58
3149839-14983982.66282.66
4147370-14737081.30081.30
5148314-14831481.82181.82
6144417-14441779.67179.67
30min1153524-15352484.69584.111.5184.6984.101.52
2150126-15012682.82082.82
3156408-15640886.28686.29
4151037-15103783.32383.32
5152675-15267584.22684.23
6150961-15096183.28183.28
45min1150959-15095983.28085.571.4283.2885.571.42
2155557-15555785.81685.82
3156935-15693586.57786.58
4154593-15459385.28585.28
5156018-15601886.07186.07
6156615-15661586.40086.40
60min1157587-15758786.93686.851.4986.9486.851.49
2153354-15335484.60184.60
3160456-16045688.51988.52
4156815-15681586.51086.51
5158194-15819487.27187.27
6158166-15816687.25687.26
90min1158450-15845087.41286.980.7387.4186.980.73
2156751-15675186.47586.48
3157024-15702486.62686.63
4157040-15704086.63486.63
5159642-15964288.07088.07
6157071-15707186.65286.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1157147-15714786.69486.582.4186.6986.582.41
2157671-15767186.98386.98
3159890-15989088.20788.21
4157629-15762986.95986.96
5159704-15970488.10488.10
6149618-14961882.54082.54
极限1153174-15317484.50286.561.5684.5086.561.56
2155850-15585085.97885.98
3159662-15966288.08188.08
4155834-15583485.96985.97
5157760-15776087.03287.03
6159167-15916787.80887.81
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%
114.501859131858281859031859341858411858840.03
214.521863491862731863110.03
单位质量响应值RSD%判断
12819.5912831.340.07数据可信
供试品溶液-2733947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%
2min115011-150118.2739.9318.228.279.9318.24
216701-167019.2049.20
316637-166379.1699.17
417691-176919.7509.75
524420-2442013.45813.46
617679-176799.7439.74
5min146031-4603125.36829.1322.9125.3729.1322.91
252354-5235428.85328.85
346725-4672525.75125.75
446683-4668325.72825.73
577111-7711142.49742.50
648200-4820026.56426.56
10min184529-8452946.58548.079.9446.5848.089.95
280665-8066544.45544.46
382092-8209245.24245.24
489188-8918849.15349.15
5103890-10389057.25557.26
683025-8302545.75645.76
15min1107828-10782859.42559.676.7359.4359.676.74
2106258-10625858.56058.56
399662-9966254.92554.92
4111561-11156161.48361.48
5120695-12069566.51666.52
6103598-10359857.09457.09
20min1117862-11786264.95566.545.1264.9666.545.12
2121452-12145266.93466.93
3115716-11571663.77263.77
4124775-12477568.76568.76
5130548-13054871.94771.95
6114120-11412062.89362.89
30min1126598-12659869.77073.252.8969.7773.252.89
2135867-13586774.87874.88
3131873-13187372.67772.68
4137500-13750075.77875.78
5134026-13402673.86373.86
6131599-13159972.52672.53
45min1146046-14604680.48880.971.2080.4980.971.20
2147110-14711081.07481.07
3144183-14418379.46179.46
4147822-14782281.46681.47
5149415-14941582.34482.34
6146999-14699981.01381.01
60min1155477-15547785.68584.532.0085.6984.532.00
2148778-14877881.99381.99
3150561-15056182.97682.98
4154365-15436585.07285.07
5156769-15676986.39786.40
6154323-15432385.04985.05
90min1159436-15943687.86786.261.7687.8786.261.76
2153644-15364484.67584.68
3156838-15683886.43586.44
4154845-15484585.33785.34
5154210-15421084.98784.99
6160103-16010388.23588.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1162912-16291289.78389.100.5989.7889.100.59
2160477-16047788.44188.44
3161221-16122188.85188.85
4160976-16097688.71688.72
5162536-16253689.57689.58
6161957-16195789.25689.26
极限1164906-16490690.88289.131.8690.8889.131.85
2161254-16125488.86988.87
3161560-16156089.03889.04
4157564-15756486.83586.84
5165340-16534091.12191.12
6159718-15971888.02288.02
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%
114.501857321858571855401856451852721856090.12
214.521861291860861861080.02
单位质量响应值RSD%判断
12800.6212817.360.10数据可信
供试品溶液-2733947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%
2min128854-2885415.92212.0620.5115.9212.0620.50
218205-1820510.04610.05
323433-2343312.93112.93
423504-2350412.97012.97
516204-162048.9428.94
620893-2089311.52911.53
5min184017-8401746.36241.2415.9646.3641.2415.97
269498-6949838.35038.35
379913-7991344.09844.10
487082-8708248.05448.05
554317-5431729.97329.97
673541-7354140.58140.58
10min1107358-10735859.24257.719.5459.2457.719.54
2105337-10533758.12758.13
3105117-10511758.00658.01
4118055-11805565.14565.15
587060-8706048.04248.04
6104530-10453057.68257.68
15min1122551-12255167.62665.676.3867.6365.676.38
2122337-12233767.50867.51
3113378-11337862.56462.56
4129202-12920271.29671.30
5107686-10768659.42359.42
6118902-11890265.61365.61
20min1126807-12680769.97571.042.8769.9771.042.87
2132924-13292473.35073.35
3126637-12663769.88169.88
4132239-13223972.97272.97
5123461-12346168.12868.13
6130305-13030571.90571.91
30min1142396-14239678.57777.483.6478.5877.483.64
2143998-14399879.46179.46
3137842-13784276.06476.06
4145685-14568580.39280.39
5131529-13152972.58072.58
6141015-14101577.81577.82
45min1150739-15073983.18182.460.9983.1882.460.99
2151709-15170983.71683.72
3148381-14838181.88081.88
4147990-14799081.66481.66
5148562-14856281.98081.98
6149216-14921682.34082.34
60min1156863-15686386.56085.791.1486.5685.791.14
2155811-15581185.98085.98
3152186-15218683.97983.98
4155351-15535185.72685.73
5155437-15543785.77385.77
6157112-15711286.69886.70
90min1160441-16044188.53587.582.1288.5387.582.12
2159648-15964888.09788.10
3152193-15219383.98383.98
4158699-15869987.57387.57
5161761-16176189.26389.26
6159483-15948388.00688.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158262-15826287.33288.302.3787.3388.302.37
2161743-16174389.25389.25
3159005-15900587.74287.74
4153813-15381384.87784.88
5163581-16358190.26790.27
6163653-16365390.30790.31
极限1162124-16212489.46389.450.9789.4689.450.97
2163137-16313790.02290.02
3159748-15974888.15288.15
4160725-16072588.69188.69
5163502-16350290.22490.22
6163407-16340790.17190.17
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