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%
113.711757131765521761251757481766961761670.26
213.761771391764961768180.26
单位质量响应值RSD%判断
12849.5312850.150.01数据可信
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%
2min194124-9412451.77456.668.3351.7756.668.33
297998-9799853.90553.91
398747-9874754.31754.32
4113793-11379362.59462.59
5113843-11384362.62162.62
699522-9952254.74454.74
5min1166719-16671991.70792.920.9991.7192.930.99
2170194-17019493.61893.62
3170392-17039293.72793.73
4170575-17057593.82893.83
5168175-16817592.50792.51
6167535-16753592.15592.16
10min1176097-17609796.86596.930.7496.8796.930.74
2176876-17687697.29497.29
3178021-17802197.92397.92
4176747-17674797.22397.22
5174339-17433995.89895.90
6175242-17524296.39596.39
15min1178246-17824698.04797.510.9998.0597.510.99
2178478-17847898.17598.17
3179223-17922398.58598.58
4176773-17677397.23797.24
5174405-17440595.93495.93
6176512-17651297.09397.09
20min1177494-17749497.63397.560.7097.6397.560.70
2177964-17796497.89297.89
3179202-17920298.57398.57
4177392-17739297.57797.58
5175591-17559196.58796.59
6176539-17653997.10897.11
30min1178482-17848298.17797.700.7798.1897.700.77
2178388-17838898.12598.13
3178746-17874698.32298.32
4178129-17812997.98397.98
5175267-17526796.40896.41
6176662-17666297.17697.18
45min1178474-17847498.17397.700.9698.1797.700.96
2178084-17808497.95897.96
3179558-17955898.76998.77
4178285-17828598.06998.07
5174824-17482496.16596.16
6176442-17644297.05597.05
60min1177581-17758197.68197.480.8197.6897.480.81
2177624-17762497.70597.71
3179151-17915198.54598.54
4177342-17734297.55097.55
5174796-17479696.14996.15
6176743-17674397.22097.22
极限1177844-17784497.82697.420.8897.8397.420.88
2177425-17742597.59697.60
3179287-17928798.62098.62
4177249-17724997.49997.50
5174852-17485296.18096.18
6175939-17593996.77896.78
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%
113.711758471758741758251766331759071760170.20
213.761763071764751763910.07
单位质量响应值RSD%判断
12838.5812819.110.11数据可信
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%
2min1117572-11757264.77867.284.7864.7867.284.78
2116509-11650964.19364.19
3125920-12592069.37869.38
4117269-11726964.61164.61
5124686-12468668.69868.70
6130665-13066571.99271.99
5min1177659-17765997.88497.661.0897.8897.651.09
2175789-17578996.85496.85
3175682-17568296.79596.79
4180241-18024199.30799.31
5175550-17555096.72296.72
6178543-17854398.37198.37
10min1185605-185605102.262101.500.74102.26101.500.74
2183498-183498101.101101.10
3183490-183490101.097101.10
4185293-185293102.090102.09
5182252-182252100.415100.41
6185247-185247102.065102.06
15min1185743-185743102.338101.600.57102.34101.600.57
2184115-184115101.441101.44
3183074-183074100.868100.87
4184906-184906101.877101.88
5183430-183430101.064101.06
6185113-185113101.991101.99
20min1185543-185543102.228101.540.46102.23101.540.46
2183513-183513101.110101.11
3183485-183485101.094101.09
4184858-184858101.851101.85
5183757-183757101.244101.24
6184602-184602101.710101.71
30min1186044-186044102.504101.800.64102.50101.800.64
2184958-184958101.906101.91
3183388-183388101.041101.04
4185972-185972102.464102.46
5183390-183390101.042101.04
6184803-184803101.820101.82
45min1186778-186778102.908101.750.83102.91101.750.83
2183803-183803101.269101.27
3183609-183609101.162101.16
4185662-185662102.294102.29
5182735-182735100.681100.68
6185441-185441102.172102.17
60min1186136-186136102.555101.480.82102.55101.480.82
2183985-183985101.370101.37
3182964-182964100.807100.81
4185397-185397102.148102.15
5182088-182088100.324100.32
6184594-184594101.705101.71
极限1186409-186409102.705101.500.72102.71101.500.72
2184057-184057101.409101.41
3183003-183003100.829100.83
4185059-185059101.961101.96
5182965-182965100.808100.81
6183784-183784101.259101.26
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%
113.711760031759371758241756051758301758400.09
213.761742821751321747070.35
单位质量响应值RSD%判断
12825.6712696.730.72数据可信
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%
2min115082-150828.35412.2728.828.3512.2728.84
226170-2617014.49614.50
332482-3248217.99217.99
422335-2233512.37112.37
519593-1959310.85310.85
617231-172319.5449.54
5min1106477-10647758.97859.093.7858.9859.093.78
2105895-10589558.65558.66
3114180-11418063.24463.24
4101952-10195256.47156.47
5106131-10613158.78658.79
6105471-10547158.42158.42
10min1151913-15191384.14582.562.3284.1482.562.32
2146940-14694081.39081.39
3154194-15419485.40885.41
4144675-14467580.13680.14
5148420-14842082.21082.21
6148190-14819082.08382.08
15min1166734-16673492.35491.091.7492.3591.091.74
2162058-16205889.76489.76
3167822-16782292.95792.96
4160213-16021388.74288.74
5164939-16493991.36091.36
6164981-16498191.38391.38
20min1173075-17307595.86694.592.0295.8794.592.01
2168801-16880193.49993.50
3171750-17175095.13395.13
4164683-16468391.21891.22
5173517-17351796.11196.11
6172819-17281995.72595.72
30min1176855-17685597.96096.552.0397.9696.552.03
2173062-17306295.85995.86
3173832-17383296.28696.29
4168064-16806493.09193.09
5176583-17658397.81097.81
6177454-17745498.29298.29
45min1178459-17845998.84997.462.3098.8597.462.30
2174291-17429196.54096.54
3175883-17588397.42297.42
4168840-16884093.52193.52
5178218-17821898.71598.72
6180032-18003299.72099.72
60min1179173-17917399.24497.772.0899.2497.772.08
2174669-17466996.74996.75
3176368-17636897.69097.69
4170205-17020594.27794.28
5178732-17873299.00099.00
6179959-17995999.67999.68
极限1179452-17945299.39998.841.4099.4098.841.40
2177418-17741898.27298.27
3180593-180593100.031100.03
4173841-17384196.29196.29
5179531-17953199.44299.44
6179874-17987499.63299.63
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%
113.711762981763751763921765841763261763950.07
213.761762451757611760030.20
单位质量响应值RSD%判断
12866.1612790.920.42数据可信
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%
2min125770-2577014.19914.3217.7114.2014.3317.72
225910-2591014.27614.28
333696-3369618.56618.57
419929-1992910.98110.98
523225-2322512.79712.80
627461-2746115.13115.13
5min1109225-10922560.18162.976.9660.1862.976.96
2122374-12237467.42667.43
3123812-12381268.21868.22
4104767-10476757.72557.72
5108363-10836359.70659.71
6117147-11714764.54664.55
10min1148093-14809381.59784.853.4181.6084.853.40
2161517-16151788.99388.99
3158093-15809387.10787.11
4149946-14994682.61882.62
5150810-15081083.09483.09
6155528-15552885.69485.69
15min1161145-16114588.78891.412.1988.7991.422.18
2171224-17122494.34294.34
3167550-16755092.31792.32
4163321-16332189.98789.99
5164525-16452590.65190.65
6167703-16770392.40292.40
20min1167700-16770092.40093.501.7092.4093.501.70
2174471-17447196.13196.13
3170932-17093294.18194.18
4167524-16752492.30392.30
5166966-16696691.99692.00
6170575-17057593.98493.98
30min1172260-17226094.91394.801.8694.9194.801.86
2176829-17682997.43097.43
3173612-17361295.65895.66
4168878-16887893.04993.05
5168143-16814392.64492.64
6172594-17259495.09795.10
45min1174320-17432096.04896.171.0596.0596.171.05
2177777-17777797.95297.95
3174855-17485596.34296.34
4173594-17359495.64895.65
5172277-17227794.92294.92
6174460-17446096.12596.12
60min1175057-17505796.45496.471.0296.4596.471.02
2178260-17826098.21898.22
3175671-17567196.79296.79
4173644-17364495.67595.68
5173387-17338795.53495.53
6174476-17447696.13496.13
极限1181522-181522100.01697.941.46100.0297.941.47
2179400-17940098.84798.85
3178477-17847798.33898.34
4177210-17721097.64097.64
5174624-17462496.21596.22
6175276-17527696.57496.57
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