厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.663215232151319293215332166321100.32
213.723231132318323140.02
单位质量响应值RSD%判断
2350.662355.250.14数据可信
供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
24032001批131898319263191285.6388.562.3786.36%~90.76%
232331323533234286.78
333371333083334089.46
432913329023290888.30
533512334683349089.87
634051340083403091.31
24032501批131238311783120883.7486.472.2284.46%~88.49%
231676316463166184.96
332109320833209686.12
432551325923257287.40
533152331783316588.99
632665326473265687.63
24032502批132364323453235486.8289.922.7587.33%~92.50%
233575335953358590.12
334462344543445892.46
433522335503353689.99
532546325813256487.38
634540345653455292.72
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952033548203268520353922032545203198620332310.07
215.092040924204021820405710.03
单位质量响应值RSD%判断
136002.07135226.710.41数据可信
供试品溶液-厄贝沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
24032001批119216701920509192109085.0086.101.1785.04%~87.15%
219337581945565193966285.82
319458551944347194510186.06
419244761926534192550585.19
519642621963365196381486.89
619795451980807198017687.61
24032501批119454791944984194523286.0686.731.0085.82%~87.64%
219408811941206194104485.88
319543661954116195424186.46
419954221995499199546088.29
519587671961372196007086.72
619659541965407196568086.97
24032502批119422811941957194211985.9386.920.6686.32%~87.51%
219612181962093196165686.79
319748351974366197460087.36
419664391965499196596986.98
519597491967360196355486.87
619784781979655197906687.56
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