氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.667342372565724747307072651728370.55
211.617375174061739060.30
单位质量响应值RSD%判断
6246.746365.721.34数据可信
供试品溶液-2024041821批-40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min110550-105501.5451.604.081.551.604.00
210625-106251.5561.56
311384-113841.6681.67
411253-112531.6481.65
510359-103591.5171.52
611254-112541.6491.65
30min114631-146312.1432.144.952.162.164.85
214224-142242.0842.10
314572-145722.1352.15
414517-145172.1262.14
513799-137992.0212.04
615950-159502.3362.35
45min120595-205953.0172.953.813.052.983.84
220360-203602.9823.02
320735-207353.0373.08
420217-202172.9613.00
518617-186172.7272.76
620168-201682.9542.99
60min124756-247563.6263.553.273.693.623.26
224295-242953.5593.63
323308-233083.4143.48
425175-251753.6883.76
523234-232343.4033.47
624564-245643.5983.67
75min127832-278324.0774.045.624.184.145.59
228384-283844.1584.26
326869-268693.9364.04
427855-278554.0804.18
525030-250303.6663.76
629635-296354.3414.45
90min129907-299074.3814.402.814.524.542.79
230697-306974.4974.64
330298-302984.4384.58
429843-298434.3714.52
528559-285594.1834.32
630926-309264.5304.68
120min126630-266303.9013.874.534.094.064.48
227492-274924.0274.22
326171-261713.8344.02
425934-259343.7993.99
524555-245553.5973.77
627904-279044.0874.28
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