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%
110.764435844319443054427444273443060.08
210.834451544512445140.01
单位质量响应值RSD%判断
4117.664110.250.13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%
5min136624-3662475.95575.786.9675.9675.786.96
236035-3603574.73474.73
338004-3800478.81778.82
433177-3317768.80668.81
534869-3486972.31572.32
640514-4051484.02384.02
10min140574-4057484.14783.713.2884.9984.553.30
239470-3947081.85882.69
340824-4082484.66685.54
440296-4029683.57184.34
538554-3855479.95880.76
642461-4246188.06188.99
15min141350-4135085.75786.113.8687.5487.893.85
240554-4055484.10685.85
342099-4209987.31089.13
442365-4236587.86289.55
539064-3906481.01682.71
643697-4369790.62492.54
20min141520-4152086.10986.823.6688.8489.553.66
240999-4099985.02987.70
341950-4195087.00189.79
442435-4243588.00790.68
539861-3986182.66885.26
644414-4441492.11195.03
30min142503-4250388.14888.142.1391.8491.842.17
242546-4254688.23791.86
342770-4277088.70292.45
442933-4293389.04092.69
540795-4079584.60688.12
643448-4344890.10894.05
45min142418-4241887.97189.072.1292.6493.742.14
242490-4249088.12192.72
343437-4343790.08594.82
443978-4397891.20795.84
541636-4163686.35090.80
643721-4372190.67495.62
极限145278-4527893.90393.280.9699.5598.940.99
245331-4533194.01399.59
345029-4502993.38799.13
445134-4513493.60499.25
544156-4415691.57696.99
644935-4493593.19299.14
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%
113.981626931625151627611624521624371625720.10
213.981627031626691626860.02
单位质量响应值RSD%判断
11628.9011637.050.05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%
5min155196-5519630.75832.098.7130.7632.098.70
255118-5511830.71530.71
361556-6155634.30234.30
452379-5237929.18829.19
555532-5553230.94530.95
665747-6574736.63836.64
10min180741-8074144.99346.314.2945.3346.664.31
280835-8083545.04645.39
384554-8455447.11847.50
484304-8430446.97947.30
579230-7923044.15144.49
688943-8894349.56449.97
15min191678-9167851.08853.516.3151.9354.386.26
292536-9253651.56652.41
398224-9822454.73655.64
4103830-10383057.86058.71
588467-8846749.29950.13
6101432-10143256.52357.48
20min198484-9848454.88157.215.5156.2958.685.49
299133-9913355.24256.66
3104510-10451058.23959.75
4109200-10920060.85262.34
595855-9585553.41554.80
6108788-10878860.62262.21
30min1109526-10952661.03462.124.1963.0564.224.20
2109342-10934260.93162.96
3114096-11409663.58065.74
4117992-11799265.75167.92
5104558-10455858.26560.24
6113329-11332963.15365.41
45min1117572-11757265.51766.794.5968.2169.584.57
2114650-11465063.88966.59
3125222-12522269.78072.65
4126314-12631470.38973.28
5113300-11330063.13765.76
6122073-12207368.02670.99
极限1157966-15796688.02787.191.3691.4590.721.40
2156431-15643187.17290.59
3158636-15863688.40092.04
4157294-15729487.65391.33
5152686-15268685.08588.41
6155788-15578886.81390.53
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