洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.991162611116976511712861169471116264311671550.36
214.001157912115664611572790.08
单位质量响应值RSD%判断
83427.8182662.790.66数据可信
长期9月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121112630551264341126369899.8699.861.1098.71%~101.00%
2127800612747801276393100.87
312601131258091125910299.50
412580191256183125710199.34
5128140312820061281704101.29
612439711243251124361198.28
20240302211127948312813961280440101.19101.841.09100.68%~102.99%
2127574912700131272881100.59
3127656612777111277138100.93
4130550413080701306787103.27
5129578712890611292424102.13
6130209713024621302280102.91
20240303211129877512893781294076102.26100.281.5698.64%~101.91%
212533291248806125106898.87
3127677612727171274746100.74
412366811244056124036898.02
5128370412773531280528101.19
6127275612726611272708100.58
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.991150607115688711555571155176115655011549550.22
214.001151807115568711537470.24
单位质量响应值RSD%判断
82555.7582410.500.13数据可信
中间条件9月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211127609612715521273824101.35101.171.3699.73%~102.60%
2129373712933661293552102.92
3125644312575581257000100.01
412481961248663124843099.33
5127211212666561269384100.99
6128792612861911287058102.40
20240302211126609012687441267417100.84100.931.1299.75%~102.11%
2126551012683401266925100.80
3127213212703141271223101.14
4129301512935701293292102.90
5126373112609951262363100.44
612534251246673125004999.46
20240303211126184112531491257495100.05100.821.1699.60%~102.05%
212572001255939125657099.97
3126032712636911262009100.41
4127684012766531276746101.58
5129648912890631292776102.86
6125418612612271257706100.07
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