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%
111.135451225419795451845452985471775449520.35
211.155442215446855444530.07
单位质量响应值RSD%判断
48962.4448829.870.20数据可信
供试品溶液-4229B批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146377-463778.5287.969.338.537.969.32
246097-460978.4768.48
336204-362046.6576.66
443283-432837.9597.96
546448-464488.5418.54
641313-413137.5977.60
10min177215-7721514.19814.062.3214.2114.072.31
277623-7762314.27314.29
373061-7306113.43413.45
476414-7641414.05114.06
577928-7792814.32914.34
676461-7646114.06014.07
15min187609-8760916.11016.130.6116.1516.160.61
288555-8855516.28316.32
386891-8689115.97816.01
487707-8770716.12816.16
587675-8767516.12216.16
687781-8778116.14116.18
20min191712-9171216.86416.870.6816.9316.940.68
291972-9197216.91216.98
390637-9063716.66616.73
492526-9252617.01417.08
591823-9182316.88416.95
691797-9179716.88016.94
30min194337-9433717.34717.521.0217.4417.621.02
295490-9549017.55917.65
394402-9440217.35917.45
497001-9700117.83717.93
595335-9533517.53017.62
695231-9523117.51117.60
45min197330-9733017.89717.980.4018.0218.100.40
297464-9746417.92218.04
397446-9744617.91818.04
498186-9818618.05418.18
598166-9816618.05118.17
697958-9795818.01318.13
60min197290-9729017.89018.150.9918.0418.300.99
299233-9923318.24718.40
398180-9818018.05318.20
499478-9947818.29218.44
599871-9987118.36418.52
698230-9823018.06318.21
90min197276-9727617.88718.371.5718.0718.551.55
2101211-10121118.61118.79
399424-9942418.28218.46
4101678-10167818.69718.88
599689-9968918.33118.51
6100221-10022118.42918.61
120min198109-9810918.04018.342.0518.2518.562.04
2102575-10257518.86119.08
398843-9884318.17518.38
4101631-10163118.68818.90
5100044-10004418.39618.61
697368-9736817.90418.12
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199083-9908318.21918.451.2218.4618.691.22
2100958-10095818.56418.81
398514-9851418.11518.35
4101119-10111918.59418.84
5101495-10149518.66318.91
6100729-10072918.52218.76
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%
111.132775742782362776882773972774632776720.13
211.152732142725982729060.16
单位质量响应值RSD%判断
24948.0724475.871.36数据可信
供试品溶液-3788B批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125577-255779.3079.4715.899.319.4715.90
217985-179856.5446.54
328263-2826310.28410.28
428884-2888410.51010.51
528623-2862310.41510.41
626898-268989.7879.79
10min151459-5145918.72418.725.4718.7418.735.49
245852-4585216.68416.69
352520-5252019.11019.13
453373-5337319.42119.44
552900-5290019.24819.27
652531-5253119.11419.13
15min164201-6420123.36023.462.6823.4123.512.69
261196-6119622.26722.31
365146-6514623.70423.75
466017-6601724.02124.07
565539-6553923.84723.90
664824-6482423.58723.64
20min171983-7198326.19226.161.7026.2826.241.70
269588-6958825.32125.40
373160-7316026.62026.71
472455-7245526.36426.45
571872-7187226.15226.24
672295-7229526.30626.39
30min180224-8022429.19129.300.4529.3229.430.45
280171-8017129.17129.29
380780-8078029.39329.53
481047-8104729.49029.62
580633-8063329.34029.47
680273-8027329.20929.34
45min187461-8746131.82431.820.7232.0032.000.71
288082-8808232.05032.22
388091-8809132.05332.24
486413-8641331.44331.63
587501-8750131.83932.02
687159-8715931.71431.89
60min191652-9165233.34933.220.3733.5833.450.36
291758-9175833.38833.61
391238-9123833.19833.43
490932-9093233.08733.32
591020-9102033.11933.35
691178-9117833.17633.41
90min194602-9460234.42234.500.4534.7134.790.44
295345-9534534.69334.97
394219-9421934.28334.57
495001-9500134.56834.86
595154-9515434.62334.91
694562-9456234.40834.70
120min196490-9649035.10934.981.0935.4535.321.07
297239-9723935.38235.72
396038-9603834.94535.29
496661-9666135.17235.52
596194-9619435.00235.35
694187-9418734.27134.62
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195442-9544234.72835.200.8035.1335.610.79
297600-9760035.51335.91
396974-9697435.28535.69
497177-9717735.35935.77
596272-9627235.03035.44
697023-9702335.30335.71
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