培哚普利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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.764527145227452554521145205452340.07
210.834487344859448660.03
单位质量响应值RSD%判断
4203.904142.751.04数据可信
供试品溶液-2022081201批-培哚普利-磷酸盐缓冲液（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%
5min140785-4078583.38673.048.9783.3973.048.97
235549-3554972.68172.68
333092-3309267.65767.66
437013-3701375.67475.67
536274-3627474.16374.16
631634-3163464.67664.68
10min147002-4700296.09781.0410.5397.0281.8510.51
239469-3946980.69581.50
336803-3680375.24576.00
440329-4032982.45483.29
539505-3950580.76981.59
634716-3471670.97871.70
15min146822-4682295.72982.529.3997.7284.239.39
240695-4069583.20284.91
337330-3733076.32277.91
440908-4090883.63785.39
540548-4054882.90184.62
635853-3585373.30274.81
20min146212-4621294.48183.917.1697.5486.547.24
240852-4085283.52386.15
339261-3926180.27082.71
441292-4129284.42287.11
541216-4121684.26786.91
637417-3741776.50078.82
30min146524-4652495.11985.126.2199.2388.686.31
241413-4141384.67088.23
340097-4009781.97985.31
441644-4164485.14288.77
541058-4105883.94487.52
639051-3905179.84183.01
45min146231-4623194.52086.845.3299.6891.355.47
242509-4250986.91191.41
340817-4081783.45187.69
443127-4312788.17492.74
542561-4256187.01791.53
639611-3961180.98685.04
极限147889-4788997.91094.672.48104.12100.142.52
246550-4655095.172100.64
345465-4546592.95498.12
444891-4489191.78197.33
545735-4573593.50698.98
647286-4728696.677101.64
培哚普利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2000
标示量(mg)10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%
113.981654501654891655841653051653771654410.07
213.981639771639941639860.01
单位质量响应值RSD%判断
11834.1211730.040.63数据可信
供试品溶液-2022081201批-氨氯地平-磷酸盐缓冲液（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%
5min162552-6255234.41728.7410.8234.4228.7410.82
250074-5007427.55127.55
349170-4917027.05427.05
452031-5203128.62828.63
553410-5341029.38729.39
646116-4611625.37425.37
10min1107288-10728859.03144.6716.4159.4144.9916.36
276427-7642742.05142.36
371598-7159839.39439.69
480885-8088544.50444.82
579051-7905143.49543.82
671893-7189339.55639.84
15min1123303-12330367.84351.3216.8568.8852.1316.80
291557-9155750.37651.15
379444-7944443.71144.45
492379-9237950.82851.64
591151-9115150.15250.96
681751-8175144.98045.70
20min1129852-12985271.44654.5615.9573.2455.9515.93
293441-9344151.41252.75
385865-8586547.24448.47
498281-9828154.07555.45
598246-9824654.05655.42
689299-8929949.13350.35
30min1139837-13983776.94058.8015.6379.5360.8015.62
2100945-10094555.54157.45
394138-9413851.79653.54
4105682-10568258.14760.13
5103697-10369757.05559.02
696943-9694353.33955.11
45min1144288-14428879.38963.3113.5282.8365.9613.60
2110096-11009660.57663.10
3101943-10194356.09058.41
4116823-11682364.27766.90
5114654-11465463.08465.69
6102580-10258056.44158.80
极限1165483-16548391.05186.993.1195.3790.343.35
2158444-15844487.17890.37
3154479-15447984.99687.94
4153198-15319884.29187.63
5154758-15475885.15088.45
6162287-16228789.29292.28
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