富马酸伏诺拉生片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052487972495792494442487962495882492410.17
215.162483522494172488840.31
单位质量响应值RSD%判断
16560.8616417.150.62数据可信
长期12月-供试品溶液-2023031011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%
5min1188224-18822476.73078.7413.4376.7378.7413.43
2152361-15236162.11162.11
3176312-17631271.87471.87
4220785-22078590.00490.00
5213372-21337286.98286.98
6207906-20790684.75484.75
10min1227257-22725792.64294.564.3792.7794.694.38
2217631-21763188.71888.82
3224871-22487191.67091.79
4241599-24159998.48998.64
5241921-24192198.62098.76
6238530-23853097.23897.38
15min1236841-23684196.54997.172.0496.8397.462.06
2230856-23085694.10994.36
3235278-23527895.91296.18
4241606-24160698.49298.81
5242531-24253198.86999.18
6243056-24305699.08399.39
20min1242699-24269998.93798.561.4599.3899.011.47
2235230-23523095.89296.30
3240593-24059398.07998.51
4244259-24425999.573100.05
5243553-24355399.28599.76
6244300-24430099.590100.06
30min1248455-248455101.28499.531.04101.89100.141.04
2242227-24222798.74599.31
3241582-24158298.48299.08
4245256-24525699.980100.62
5242908-24290899.02299.66
6244503-24450399.673100.31
45min1248734-248734101.397100.020.91102.17100.800.91
2243584-24358499.298100.03
3243804-24380499.388100.15
4245890-245890100.238101.05
5243160-24316099.12599.93
6246990-246990100.686101.49
60min1249397-249397101.668100.250.91102.61101.200.91
2243628-24362899.316100.21
3246666-246666100.554101.48
4243326-24332699.193100.17
5246166-246166100.351101.32
6246323-246323100.415101.38
极限1250283-250283102.029100.651.05103.14101.761.03
2246660-246660100.552101.62
3247934-247934101.071102.16
4242414-24241498.82199.96
5246392-246392100.443101.58
6247669-247669100.963102.10
富马酸伏诺拉生片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052485312488902498092493792491822491580.20
215.162496362487662492010.25
单位质量响应值RSD%判断
16555.3516438.060.51数据可信
长期12月-供试品溶液-2023031111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%
5min1190709-19070977.70682.996.4177.7182.996.40
2200884-20088481.85281.85
3206740-20674084.23884.24
4218430-21843089.00289.00
5187755-18775576.50376.50
6217574-21757488.65388.65
10min1235991-23599196.15796.383.5996.2996.523.59
2239417-23941797.55397.69
3231693-23169394.40694.55
4242455-24245598.79198.94
5222856-22285690.80590.93
6246778-246778100.552100.70
15min1242325-24232598.73898.632.1699.0398.932.17
2242574-24257498.83999.14
3237749-23774996.87397.17
4247128-247128100.695101.01
5234566-23456695.57795.86
6247999-247999101.050101.37
20min1243090-24309099.05099.191.6499.5099.651.65
2244681-24468199.698100.16
3240797-24079798.11598.57
4246844-246844100.579101.06
5237197-23719796.64997.09
6247953-247953101.031101.51
30min1245579-245579100.064100.051.36100.68100.681.38
2247221-247221100.733101.36
3243939-24393999.396100.02
4248462-248462101.239101.89
5239740-23974097.68598.28
6248377-248377101.204101.86
45min1246151-246151100.297100.480.92101.08101.280.94
2246653-246653100.501101.30
3245075-24507599.859100.65
4249260-249260101.564102.38
5243420-24342099.18499.95
6249040-249040101.474102.29
60min1247413-247413100.811100.720.73101.76101.680.75
2247623-247623100.897101.86
3246711-246711100.525101.48
4247811-247811100.973101.96
5244055-24405599.443100.37
6249513-249513101.667102.66
极限1247641-247641100.904100.740.73102.03101.880.74
2246899-246899100.602101.74
3248413-248413101.219102.34
4248743-248743101.353102.51
5243856-24385699.362100.45
6247947-247947101.029102.19
富马酸伏诺拉生片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052468302474752462532463042458792465480.26
215.162470432459722465080.31
单位质量响应值RSD%判断
16381.9316260.420.53数据可信
中间条件12月-供试品溶液-2023031011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%
5min1199474-19947482.15280.895.4382.1580.885.43
2192888-19288879.44079.44
3196831-19683181.06481.06
4177813-17781373.23173.23
5209418-20941886.24786.25
6201965-20196583.17883.18
10min1234696-23469696.65895.171.9796.7995.301.97
2225716-22571692.96093.09
3236759-23675997.50897.64
4225872-22587293.02493.15
5232397-23239795.71195.85
6231084-23108495.17095.31
15min1240771-24077199.16098.111.2799.4698.401.27
2233466-23346696.15296.44
3241665-24166599.52899.83
4239416-23941698.60298.88
5237147-23714797.66797.97
6236836-23683697.53997.84
20min1243225-243225100.17198.930.99100.6399.390.98
2236743-23674397.50197.95
3241083-24108399.28999.75
4241830-24183099.596100.04
5238373-23837398.17298.64
6240065-24006598.86999.33
30min1244710-244710100.78299.271.33101.4199.891.33
2240461-24046199.03299.64
3245133-245133100.956101.59
4237926-23792697.98898.60
5237915-23791597.98498.61
6240088-24008898.87999.50
45min1243239-243239100.17699.940.73100.97100.730.74
2241569-24156999.489100.26
3245744-245744101.208102.01
4240787-24078799.16799.94
5241645-24164599.520100.31
6243001-243001100.078100.87
60min1242303-24230399.79199.550.74100.76100.500.74
2242041-24204199.683100.62
3244321-244321100.622101.59
4239943-23994398.81999.76
5239430-23943098.60899.57
6242231-24223199.761100.72
极限1241538-24153899.476100.100.81100.61101.220.81
2243761-243761100.391101.50
3245937-245937101.288102.42
4240775-24077599.162100.26
5244367-244367100.641101.76
6241936-24193699.640100.76
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