托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.581005251008501009361007981005291007280.19
216.481009011010671009840.12
单位质量响应值RSD%判断
6075.276127.670.61数据可信
供试品溶液-24062701批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119489-1948919.12720.596.7119.1320.596.71
219063-1906318.70918.71
321114-2111420.72220.72
422569-2256922.15022.15
521935-2193521.52721.53
621717-2171721.31421.31
10min132237-3223731.63834.214.3731.7434.334.38
233777-3377733.14933.25
335531-3553134.87134.99
435932-3593235.26435.39
535886-3588635.21935.34
635794-3579435.12935.25
15min141087-4108740.32441.563.2740.6141.863.26
241536-4153640.76441.05
344018-4401843.20043.51
444185-4418543.36443.68
541431-4143140.66140.98
641793-4179341.01741.33
20min146685-4668545.81847.503.4746.3248.043.46
246332-4633245.47145.99
348551-4855147.64948.20
448759-4875947.85348.41
549229-4922948.31448.86
650851-5085149.90650.45
30min154606-5460653.59154.663.7154.3555.463.70
253210-5321052.22152.99
354787-5478753.76954.58
459233-5923358.13358.96
556464-5646455.41556.22
655890-5589054.85255.67
45min158067-5806756.98859.945.3358.0561.055.26
260270-6027059.15060.21
363018-6301861.84762.96
462994-6299461.82462.97
556843-5684355.78756.90
665287-6528764.07465.20
60min164551-6455163.35264.372.5064.7365.812.51
263597-6359762.41563.80
367395-6739566.14367.60
467406-6740666.15467.65
564409-6440963.21264.64
666182-6618264.95266.43
90min174187-7418772.80970.744.5574.5472.534.43
270146-7014668.84370.58
373608-7360872.24074.06
466833-6683365.59167.45
571670-7167070.33872.12
676011-7601174.59976.44
120min174541-7454173.15675.084.4075.2977.274.35
272095-7209570.75672.87
377629-7762976.18778.41
480217-8021778.72780.95
574346-7434672.96575.13
680195-8019578.70580.96
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限172604-7260471.25573.832.2573.7976.432.22
275652-7565274.24676.75
375339-7533973.93976.59
474195-7419572.81775.48
575987-7598774.57577.15
677585-7758576.14478.84
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