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%
113.711772021771531767061768151767801769310.13
213.761768911771591770250.11
单位质量响应值RSD%判断
12905.2512865.190.22数据可信
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%
2min1126110-12611069.17964.536.3669.1864.536.36
2114606-11460662.86862.87
3119370-11937065.48165.48
4105104-10510457.65657.66
5123753-12375367.88667.89
6116830-11683064.08864.09
5min1164272-16427290.11389.581.0290.1189.581.02
2161692-16169288.69788.70
3161552-16155288.62188.62
4163153-16315389.49989.50
5163186-16318689.51789.52
6165977-16597791.04891.05
10min1169171-16917192.80092.491.2692.8092.491.26
2166087-16608791.10891.11
3166594-16659491.38691.39
4170371-17037193.45893.46
5167957-16795792.13492.13
6171432-17143294.04094.04
15min1169401-16940192.92693.240.6892.9393.240.67
2169003-16900392.70892.71
3168515-16851592.44092.44
4171075-17107593.84493.84
5170906-17090693.75293.75
6170981-17098193.79393.79
20min1170940-17094093.77093.250.5293.7793.240.52
2168553-16855392.46192.46
3169351-16935192.89992.90
4170568-17056893.56693.57
5170125-17012593.32393.32
6170363-17036393.45493.45
30min1170433-17043393.49293.140.7593.4993.140.75
2168028-16802892.17392.17
3169086-16908692.75392.75
4169863-16986393.18093.18
5169529-16952992.99693.00
6171761-17176194.22194.22
45min1170007-17000793.25993.470.8293.2693.470.82
2170521-17052193.54193.54
3170637-17063793.60493.60
4172818-17281894.80194.80
5168579-16857992.47592.48
6169827-16982793.16093.16
60min1172532-17253294.64494.350.8394.6494.350.83
2170631-17063193.60193.60
3169812-16981293.15293.15
4172853-17285394.82094.82
5173366-17336695.10195.10
6172777-17277794.77894.78
极限1175172-17517296.09294.522.0096.0994.522.00
2172902-17290294.84794.85
3171829-17182994.25894.26
4165709-16570990.90190.90
5173754-17375495.31495.31
6174443-17444395.69295.69
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%
113.711773221773431768151773281767221771060.18
213.761779671780821780240.05
单位质量响应值RSD%判断
12918.0212937.790.11数据可信
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%
2min1113454-11345462.03061.708.2962.0361.708.29
2121457-12145766.40666.41
3114596-11459662.65562.65
496383-9638352.69752.70
5109535-10953559.88859.89
6121666-12166666.52066.52
5min1173898-17389895.07894.090.7195.0894.090.71
2171990-17199094.03594.03
3170369-17036993.14893.15
4172229-17222994.16594.17
5171267-17126793.63993.64
6172763-17276394.45794.46
10min1178363-17836397.51996.410.8897.5296.410.88
2175273-17527395.83095.83
3174406-17440695.35695.36
4175310-17531095.85095.85
5177448-17744897.01997.02
6177182-17718296.87396.87
15min1179118-17911897.93296.870.8597.9396.870.85
2176445-17644596.47096.47
3175621-17562196.02096.02
4178930-17893097.82997.83
5176046-17604696.25296.25
6176905-17690596.72296.72
20min1179394-17939498.08396.751.2798.0896.751.27
2175656-17565696.03996.04
3173950-17395095.10695.11
4179563-17956398.17598.18
5175809-17580996.12396.12
6177337-17733796.95896.96
30min1178918-17891897.82397.200.9297.8297.200.91
2176474-17647496.48696.49
3175614-17561496.01696.02
4179855-17985598.33598.33
5178642-17864297.67297.67
6177140-17714096.85096.85
45min1181221-18122199.08296.961.7899.0896.961.78
2174106-17410695.19295.19
3173109-17310994.64694.65
4179607-17960798.19998.20
5177912-17791297.27397.27
6178069-17806997.35897.36
60min1179966-17996698.39697.101.2598.4097.111.26
2178210-17821097.43597.44
3173519-17351994.87194.87
4177500-17750097.04797.05
5178996-17899697.86597.87
6177442-17744297.01697.02
极限1179266-17926698.01397.341.0298.0197.341.02
2176868-17686896.70296.70
3175553-17555395.98395.98
4180169-18016998.50798.51
5179316-17931698.04098.04
6176999-17699996.77396.77
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%
113.711778751778341779681779161780631779310.05
213.761796131797631796880.06
单位质量响应值RSD%判断
12978.1913058.720.44数据可信
供试品溶液-2763566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%
2min134183-3418318.56015.8921.5718.5615.8921.57
231285-3128516.98616.99
335912-3591219.49819.50
420053-2005310.88810.89
523065-2306512.52312.52
631113-3111316.89316.89
5min1100632-10063254.63855.298.7554.6455.308.74
2109294-10929459.34159.34
3103104-10310455.98055.98
486099-8609946.74746.75
5100671-10067154.65954.66
6111253-11125360.40460.40
10min1139804-13980475.90672.846.9275.9172.846.92
2140833-14083376.46576.46
3131840-13184071.58271.58
4117775-11777563.94663.95
5131845-13184571.58571.58
6142820-14282077.54477.54
15min1150469-15046981.69777.396.9781.7077.396.97
2146792-14679279.70079.70
3139374-13937475.67375.67
4126761-12676168.82468.82
5137832-13783274.83574.84
6153982-15398283.60483.60
20min1156048-15604884.72679.487.4684.7379.487.46
2150649-15064981.79481.79
3141641-14164176.90476.90
4129605-12960570.36970.37
5141506-14150676.83076.83
6158889-15888986.26886.27
30min1160324-16032487.04781.285.6387.0581.285.63
2153353-15335383.26383.26
3145687-14568779.10079.10
4137098-13709874.43774.44
5145830-14583079.17879.18
6155873-15587384.63184.63
45min1163298-16329888.66282.937.3988.6682.937.39
2157761-15776185.65685.66
3147807-14780780.25180.25
4135086-13508673.34573.34
5147884-14788480.29380.29
6164584-16458489.36089.36
60min1166260-16626090.27084.846.2590.2784.846.25
2158275-15827585.93585.93
3151571-15157182.29582.30
4141999-14199977.09877.10
5151841-15184182.44282.44
6167558-16755890.97590.98
极限1179327-17932797.36594.324.1997.3794.324.19
2173375-17337594.13394.13
3174750-17475094.88094.88
4160276-16027687.02187.02
5173654-17365494.28594.28
6180891-18089198.21498.21
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%
113.711759051755191759071759561756021757780.12
213.761785821781071783440.19
单位质量响应值RSD%判断
12821.1512961.050.77数据可信
供试品溶液-2763566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%
2min127067-2706714.84115.9131.7214.8415.9131.72
237633-3763320.63520.63
329781-2978116.33016.33
432304-3230417.71317.71
535393-3539319.40719.41
611894-118946.5226.52
5min187824-8782448.15652.5517.6548.1652.5617.66
2109161-10916159.85559.86
3111431-11143161.10061.10
485578-8557846.92446.92
5110346-11034660.50560.51
670734-7073438.78538.78
10min1124484-12448468.25768.4413.0968.2668.4413.09
2141180-14118077.41277.41
3136173-13617374.66774.67
4105808-10580858.01758.02
5137109-13710975.18075.18
6104191-10419157.13057.13
15min1133293-13329373.08772.6211.8073.0972.6211.80
2148254-14825481.29181.29
3144059-14405978.99178.99
4112649-11264961.76861.77
5142488-14248878.12978.13
6113934-11393462.47362.47
20min1135894-13589474.51474.2611.2774.5174.2611.27
2152105-15210583.40283.40
3146348-14634880.24680.25
4115440-11544063.29863.30
5144337-14433779.14379.14
6118458-11845864.95364.95
30min1140437-14043777.00576.8710.8577.0076.8610.85
2156173-15617385.63385.63
3150787-15078782.68082.68
4121105-12110566.40566.40
5150312-15031282.41982.42
6122297-12229767.05867.06
45min1143921-14392178.91579.069.7578.9279.069.75
2158502-15850286.91086.91
3154535-15453584.73584.73
4124433-12443368.22968.23
5153577-15357784.21084.21
6130161-13016171.37071.37
60min1148524-14852481.43980.889.4781.4480.889.47
2161559-16155988.58688.59
3157843-15784386.54986.55
4128538-12853870.48070.48
5156304-15630485.70585.70
6132295-13229572.54072.54
极限1177964-17796497.58295.441.2697.5895.441.26
2174909-17490995.90695.91
3172802-17280294.75194.75
4173705-17370595.24695.25
5173368-17336895.06195.06
6171659-17165994.12494.12
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