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%
114.942478422481362477602480602477252479050.08
214.982472932475692474310.08
单位质量响应值RSD%判断
16593.3716517.420.33数据可信
长期24月-供试品溶液-pH4.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121124620124627524623899.9898.550.8797.65%～99.44%
224288524228524258598.49
323995224005324000297.44
424165324140624153098.06
524250924242124246598.44
624370124339024354698.88
20240302211246919247219247069100.3197.951.4496.47%～99.43%
223992223980423986397.39
323958923982823970897.32
423916523910523913597.09
524409024354424381798.99
623815623774423795096.61
2024030321123899623916123907897.0798.761.8096.90%～100.63%
2248185248261248223100.78
324133024145924139498.01
4249214249462249338101.23
524044824009024026997.55
624123124119524121397.94
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%
114.942471992469032469782463972462622467480.17
214.982467522471882469700.13
单位质量响应值RSD%判断
16515.9316486.650.13数据可信
中间条件24月-供试品溶液-pH4.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211245533245641245587100.0498.111.4296.65%～99.57%
223748123696423722296.63
324100024067724083898.10
424138624152224145498.35
523694723659823677296.45
624312624341224326999.09
2024030221124409324403824406699.4298.371.1097.24%～99.49%
224193824181524187698.53
323747323816723782096.87
423888023923623905897.38
524155424186824171198.46
624476224399524437899.55
2024030321124222224173624197998.5798.731.2497.44%～100.01%
223960423979523970097.64
3246929246944246936100.59
423914723906223910497.40
524464324490724477599.71
624163324176224169898.45
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%
114.941238511234561236781236131233691235930.16
214.981237201235791236500.09
单位质量响应值RSD%判断
8272.628254.340.16数据可信
长期24月-供试品溶液-pH4.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121112144512175612160098.9199.150.6498.48%～99.82%
212180612180712180699.08
312256412257112256899.70
412226312247412236899.54
512045412057112051298.03
612248412250112249299.64
2024030221112081512075312078498.2599.771.2898.43%～101.11%
212289012295112292099.99
3123275123372123324100.31
4123195123618123406100.38
5124726124683124704101.44
612069612088612079198.25
2024030321112288112282712285499.93100.261.5198.68%～101.85%
2123491123538123514100.47
3123636123904123770100.68
4125365125391125378101.99
5124282124047124164101.00
612013211962411987897.51
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%
114.941234951235521237151232021230011233930.24
214.981233221235001234110.11
单位质量响应值RSD%判断
8259.248238.380.18数据可信
中间条件24月-供试品溶液-pH4.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121112106312106612106498.6599.480.5898.88%～100.09%
212206012248612227399.64
3122940123294123117100.32
412230212218412224399.61
512225712229212227499.64
612174712135312155099.05
2024030221112135712151412143698.9599.901.8997.92%～101.88%
2123545123709123627100.74
3125317125488125402102.19
411901311917611909497.05
5124292124502124397101.37
612159912166012163099.11
20240303211123308123102123205100.40101.161.05100.05%～102.27%
2124967124853124910101.79
312172712208812190899.34
4125013124775124894101.77
5125363125036125200102.02
6124721124735124728101.64
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