氢溴酸伏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%
114.151798161801491798121797911797991798730.09
214.181797591802101799840.18
单位质量响应值RSD%判断
12711.8712692.810.11数据可信
供试品溶液-24050603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%
2min1154932-15493286.21380.623.6786.2180.623.67
2141089-14108978.51078.51
3142769-14276979.44479.44
4146631-14663181.59381.59
5141358-14135878.65978.66
6142499-14249979.29479.29
5min1172030-17203095.72794.911.3795.7394.921.37
2169708-16970894.43594.43
3166444-16644492.61892.62
4172864-17286496.19196.19
5170363-17036394.79994.80
6172010-17201095.71695.72
10min1175521-17552197.66997.410.7997.6797.410.79
2176960-17696098.47098.47
3175056-17505697.41197.41
4174687-17468797.20597.21
5172756-17275696.13196.13
6175305-17530597.54997.55
15min1176045-17604597.96197.111.3497.9697.101.33
2175487-17548797.65097.65
3176905-17690598.43998.44
4175423-17542397.61597.61
5171777-17177795.58695.59
6171409-17140995.38195.38
20min1177222-17722298.61697.500.7298.6297.500.72
2175703-17570397.77197.77
3174833-17483397.28797.29
4174525-17452597.11597.12
5173531-17353196.56296.56
6175438-17543897.62397.62
30min1177181-17718198.59397.860.7298.5997.860.72
2176827-17682798.39698.40
3175019-17501997.39097.39
4176533-17653398.23298.23
5173870-17387096.75196.75
6175752-17575297.79897.80
45min1179078-17907899.64997.921.1299.6597.921.12
2176942-17694298.46098.46
3175635-17563597.73397.73
4175521-17552197.66997.67
5173157-17315796.35496.35
6175469-17546997.64097.64
60min1176377-17637798.14697.940.4298.1597.940.42
2176987-17698798.48598.49
3176096-17609697.98997.99
4175091-17509197.43097.43
5175212-17521297.49797.50
6176288-17628898.09698.10
极限1178905-17890599.55297.633.2499.5597.633.24
2177502-17750298.77298.77
3178596-17859699.38099.38
4176984-17698498.48398.48
5164011-16401191.26591.26
6176721-17672198.33798.34
氢溴酸伏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%
114.151801661802431804661801351802851802590.08
214.181805431811661808540.25
单位质量响应值RSD%判断
12739.1512754.160.09数据可信
供试品溶液-24050603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%
2min1133713-13371374.14673.007.5174.1573.007.51
2139488-13948877.34977.35
3136073-13607375.45575.46
4112107-11210762.16562.17
5132380-13238073.40773.41
6136127-13612775.48575.49
5min1174157-17415796.57395.831.5696.5795.831.56
2172429-17242995.61595.62
3175143-17514397.12097.12
4167817-16781793.05893.06
5172646-17264695.73695.74
6174727-17472796.88996.89
10min1178121-17812198.77298.130.6998.7798.130.70
2175323-17532397.22097.22
3177958-17795898.68198.68
4175800-17580097.48497.48
5176661-17666197.96297.96
6177955-17795598.67998.68
15min1178490-17849098.97698.190.9298.9898.190.92
2174902-17490296.98796.99
3178403-17840398.92898.93
4175149-17514997.12397.12
5177555-17755598.45898.46
6177942-17794298.67298.67
20min1178544-17854499.00698.220.6499.0198.220.64
2175817-17581797.49497.49
3178298-17829898.87098.87
4176920-17692098.10698.11
5176062-17606297.63097.63
6177088-17708898.19998.20
30min1179323-17932399.43898.640.7199.4498.640.71
2176228-17622897.72297.72
3178495-17849598.97998.98
4177306-17730698.32098.32
5176929-17692998.11198.11
6179040-17904099.28199.28
45min1180134-18013499.88898.980.9799.8998.980.97
2175505-17550597.32197.32
3179490-17949099.53199.53
4177631-17763198.50098.50
5178529-17852998.99899.00
6179684-17968499.63899.64
60min1178812-17881299.15599.240.7499.1599.240.74
2177233-17723398.27998.28
3180271-18027199.96499.96
4178500-17850098.98298.98
5178204-17820498.81898.82
6180748-180748100.228100.23
极限1179888-17988899.75198.770.9699.7598.770.96
2175068-17506897.07997.08
3178510-17851098.98798.99
4177686-17768698.53098.53
5178093-17809398.75698.76
6179474-17947499.52299.52
氢溴酸伏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%
114.151805581807771804891802381803271804780.12
214.181806331803531804930.11
单位质量响应值RSD%判断
12754.6312728.700.15数据可信
供试品溶液-24050602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%
2min1133023-13302373.79372.0310.9673.7972.0210.96
2133577-13357774.10074.10
3104108-10410857.75357.75
4147842-14784282.01382.01
5130521-13052172.40572.40
6129977-12997772.10372.10
5min1172543-17254395.71694.461.6695.7294.461.66
2167080-16708092.68592.69
3166696-16669692.47292.47
4173104-17310496.02796.03
5172144-17214495.49595.49
6170117-17011794.37094.37
10min1171239-17123994.99395.611.1494.9995.611.14
2170256-17025694.44794.45
3175108-17510897.13997.14
4174423-17442396.75996.76
5171162-17116294.95094.95
6171907-17190795.36395.36
15min1175339-17533997.26796.381.2697.2796.381.26
2169949-16994994.27794.28
3174020-17402096.53596.54
4175222-17522297.20297.20
5175440-17544097.32397.32
6172444-17244495.66195.66
20min1175365-17536597.28196.791.2297.2896.791.22
2171677-17167795.23695.24
3175608-17560897.41697.42
4176515-17651597.91997.92
5175795-17579597.52097.52
6171865-17186595.34095.34
30min1175691-17569197.46296.851.3797.4696.851.37
2170809-17080994.75494.75
3176127-17612797.70497.70
4176772-17677298.06298.06
5175709-17570997.47297.47
6172434-17243495.65595.66
45min1174022-17402296.53697.241.3596.5497.251.35
2171770-17177095.28795.29
3177288-17728898.34898.35
4177902-17790298.68998.69
5176657-17665797.99898.00
6174147-17414796.60696.61
60min1176710-17671098.02897.481.1498.0397.481.14
2173484-17348496.23896.24
3177309-17730998.36098.36
4177098-17709898.24398.24
5176851-17685198.10698.11
6172870-17287095.89795.90
极限1176752-17675298.05197.181.2498.0597.181.24
2173277-17327796.12396.12
3177599-17759998.52198.52
4177010-17701098.19498.19
5173632-17363296.32096.32
6172783-17278395.84995.85
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