培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.704068240697408384066740802407370.19
29.674045140754406020.53
单位质量响应值RSD%判断
4199.694198.760.02数据可信
供试品溶液-24030801批-培哚普利-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124437-2443749.65154.8424.1949.6554.8424.20
216932-1693234.40234.40
335904-3590472.95072.95
428246-2824657.39057.39
524949-2494950.69150.69
631492-3149263.98663.99
10min127950-2795056.78962.8415.3457.3463.4515.42
223427-2342747.59947.98
336624-3662474.41375.22
431459-3145963.91964.56
531390-3139063.77864.34
634717-3471770.53871.25
15min128145-2814557.18564.2813.2858.3765.5913.38
225298-2529851.40152.31
335989-3598973.12374.76
432143-3214365.30866.66
532669-3266966.37767.65
635575-3557572.28173.78
20min129839-2983960.62766.6911.6162.4568.7111.77
227130-2713055.12356.61
337556-3755676.30678.76
433157-3315767.36969.44
533569-3356968.20670.22
635683-3568372.50174.80
30min131402-3140263.80368.618.5466.2971.388.79
229270-2927059.47161.57
336786-3678674.74278.04
434016-3401669.11471.94
535498-3549872.12574.89
635650-3565072.43475.54
45min133494-3349468.05370.804.9371.2574.325.29
232203-3220365.43068.19
336647-3664774.46078.59
435166-3516671.45075.04
536412-3641273.98277.55
635154-3515471.42675.33
极限136610-3661074.38475.771.6578.3480.082.09
236491-3649174.14377.63
337268-3726875.72180.68
437849-3784976.90281.29
537676-3767676.55080.94
637852-3785276.90881.61
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.014154141300412304175641555414760.52
214.044169741700416980.01
单位质量响应值RSD%判断
2960.462969.940.23数据可信
供试品溶液-24030801批-左氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125936-2593656.70150.0711.4156.7050.0611.41
218401-1840140.22840.23
322301-2230148.75548.75
423150-2315050.61150.61
524944-2494454.53354.53
622672-2267249.56649.57
10min137596-3759682.19275.655.1782.8276.205.20
232628-3262871.33171.78
333324-3332472.85373.39
435525-3552577.66578.23
534724-3472475.91476.52
633817-3381773.93174.48
15min137202-3720281.33178.712.6082.8780.112.65
235432-3543277.46278.70
334506-3450675.43776.79
436376-3637679.52580.95
536477-3647779.74681.20
636030-3603078.76980.14
20min138129-3812983.35880.982.1485.8083.252.22
235980-3598078.66080.76
336835-3683580.52982.72
437567-3756782.12984.44
537332-3733281.61583.95
636395-3639579.56781.81
30min137836-3783682.71781.021.7586.0984.191.84
236386-3638679.54782.52
336558-3655879.92383.01
437382-3738281.72584.95
537682-3768282.38085.62
636518-3651879.83682.97
45min135728-3572878.10979.082.1182.4083.152.09
235396-3539677.38381.24
335923-3592378.53582.51
436445-3644579.67683.81
537558-3755882.10986.27
635970-3597078.63882.66
极限138421-3842183.99680.512.3389.1685.462.31
236264-3626479.28084.00
336489-3648979.77284.62
436840-3684080.54085.55
536006-3600678.71683.79
636950-3695080.78085.67
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