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对照品来源自制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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.703987039778397533982639754397960.13
29.673954539583395640.07
单位质量响应值RSD%判断
4102.684091.420.20数据可信
供试品溶液-24030801批-培哚普利-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min128804-2880459.98466.8720.0259.9866.8720.02
225133-2513352.33952.34
325208-2520852.49552.50
437196-3719677.46077.46
538582-3858280.34680.35
637729-3772978.57078.57
10min133961-3396170.72373.0414.5771.3973.7914.62
228065-2806558.44559.03
330435-3043563.38063.96
438109-3810979.36180.22
538919-3891981.04881.94
640962-4096285.30286.18
15min134474-3447471.79173.6611.2173.2475.2211.32
229407-2940761.23962.47
332366-3236667.40268.69
438012-3801279.15980.90
538987-3898781.19082.98
638994-3899481.20483.02
20min135458-3545873.84173.8010.2376.0976.1710.37
229644-2964461.73363.64
332787-3278768.27870.31
437297-3729777.67080.29
538612-3861280.40983.10
638841-3884180.88683.61
30min135700-3570074.34474.387.6777.4177.587.88
230906-3090664.36166.96
334615-3461572.08574.88
437602-3760278.30581.79
536942-3694276.93180.52
638550-3855080.28083.90
45min136350-3635075.69876.185.7479.5980.206.05
233022-3302268.76872.08
335775-3577574.50178.10
437069-3706977.19581.55
538554-3855480.28884.73
638712-3871280.61785.13
极限138022-3802279.18078.422.6283.9283.282.98
235708-3570874.36178.44
337996-3799679.12683.55
437725-3772578.56283.77
538007-3800779.14984.48
638484-3848480.14285.55
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1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.014114840880410914094740960410050.27
214.044134040940411400.69
单位质量响应值RSD%判断
2926.842930.200.09数据可信
供试品溶液-24030801批-左氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min135834-3583479.32180.691.2379.3280.691.23
236363-3636380.49280.49
336577-3657780.96680.97
436145-3614580.01080.01
537132-3713282.19582.19
636658-3665881.14581.15
10min138054-3805484.23685.481.4185.1286.381.40
238771-3877185.82386.72
338571-3857185.38086.28
438899-3889986.10687.00
539421-3942187.26288.17
637979-3797984.07084.97
15min137705-3770583.46387.334.1285.2889.184.03
240153-4015388.88290.73
339363-3936387.13388.98
439475-3947587.38189.23
537890-3789083.87385.76
642134-4213493.26795.10
20min139394-3939487.20287.833.4889.9590.653.39
239246-3924686.87489.71
338957-3895786.23489.05
437881-3788183.85386.67
540946-4094690.63793.45
641646-4164692.18795.06
30min140004-4000488.55288.421.1692.2792.211.14
239374-3937487.15890.96
339548-3954887.54391.32
440114-4011488.79692.54
539939-3993988.40892.23
640681-4068190.05193.95
45min139873-3987388.26290.022.6492.9694.802.57
239972-3997288.48193.25
340294-4029489.19493.94
439809-3980988.12092.86
542071-4207193.12897.93
641996-4199692.96297.86
极限140620-4062089.91691.062.4695.5996.832.40
240203-4020388.99394.74
340573-4057389.81295.55
440685-4068590.06095.77
541914-4191492.78098.62
642818-4281894.781100.71
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