多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.933484834906349573484634841348800.15
211.093614636144361450.01
单位质量响应值RSD%判断
3191.223259.241.50数据可信
供试品溶液-J187N批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113555-1355537.79236.5513.7037.7936.5413.69
29575-957526.69526.70
313150-1315036.66236.66
413741-1374138.31038.31
514064-1406439.21139.21
614563-1456340.60240.60
10min122549-2254962.86760.905.7162.9360.965.72
219820-1982055.25955.30
321390-2139059.63659.70
422489-2248962.70062.76
521426-2142659.73659.80
623382-2338265.18965.26
15min127011-2701175.30774.213.8675.4774.373.87
225135-2513570.07770.21
325616-2561671.41871.58
426837-2683774.82274.99
527303-2730376.12176.29
627794-2779477.49077.67
20min129630-2963082.60981.403.0482.9081.683.05
228119-2811978.39678.65
328157-2815778.50278.78
429225-2922581.48081.77
529773-2977383.00883.30
630272-3027284.39984.70
30min131700-3170088.38088.172.6588.8188.592.65
231021-3102186.48786.87
330404-3040484.76785.18
431841-3184188.77389.20
531926-3192689.01089.44
632846-3284691.57592.02
45min133169-3316992.47692.142.5393.0592.712.54
232486-3248690.57291.10
331930-3193089.02189.57
433008-3300892.02792.60
533294-3329492.82493.40
634405-3440595.92296.52
60min133643-3364393.79793.773.8294.5394.493.82
232875-3287591.65692.34
332138-3213889.60190.30
433647-3364793.80894.54
533531-3353193.48594.22
635962-35962100.263101.02
极限134889-3488997.27196.481.5298.1697.361.53
234466-3446696.09296.92
333734-3373494.05194.90
434503-3450396.19597.08
534754-3475496.89597.78
635294-3529498.40099.33
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.932776462780822781452777312777632778730.09
211.092853892850512852200.09
单位质量响应值RSD%判断
25422.9625718.670.82数据可信
供试品溶液-3788B批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1112124-11212439.42534.9119.0039.4334.9119.00
298540-9854034.64934.65
380260-8026028.22128.22
4104104-10410436.60536.61
575569-7556926.57226.57
6125078-12507843.98043.98
10min1180493-18049363.46661.187.0863.5361.247.09
2180905-18090563.61063.67
3163240-16324057.39957.45
4180156-18015663.34763.41
5154206-15420654.22254.27
6185033-18503365.06265.14
15min1204137-20413771.77971.832.4271.9572.002.44
2209008-20900873.49273.66
3198493-19849369.79569.94
4206827-20682772.72572.89
5198222-19822269.70069.83
6209071-20907173.51473.70
20min1222661-22266178.29377.042.0278.5877.322.04
2223045-22304578.42878.71
3216271-21627176.04676.31
4219867-21986777.31077.60
5211601-21160174.40474.65
6221197-22119777.77878.08
30min1230730-23073081.13083.121.4781.5583.531.46
2238786-23878683.96384.38
3237950-23795083.66984.05
4234487-23448782.45182.87
5236019-23601982.99083.36
6240347-24034784.51284.95
45min1243458-24345885.60687.071.3086.1687.621.30
2250409-25040988.05088.61
3251194-25119488.32688.85
4248457-24845787.36387.92
5244065-24406585.81986.33
6248215-24821587.27887.85
60min1256217-25621790.09290.341.0090.7991.030.98
2258566-25856690.91891.62
3261070-26107091.79892.47
4254010-25401089.31690.02
5256611-25661190.23090.89
6254988-25498889.66090.38
极限1256970-25697090.35792.391.5791.2193.231.56
2268843-26884394.53295.39
3265598-26559893.39194.22
4260968-26096891.76292.61
5261157-26115791.82992.64
6262913-26291392.44693.32
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