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%
19.952051620767205312061820764206390.59
29.992065520510205820.50
单位质量响应值RSD%判断
2074.272060.260.48数据可信
供试品溶液-2022081601批-培哚普利-醋酸盐缓冲液（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%
5min119929-1992982.25284.2112.1282.2584.2012.12
222466-2246692.72392.72
322614-2261493.33393.33
416208-1620866.89466.89
519278-1927879.56579.56
621919-2191990.46590.46
10min122747-2274793.88296.181.9294.8097.121.84
222940-2294094.67995.71
323077-2307795.24496.28
423746-2374698.00598.75
523833-2383398.36499.25
623478-2347896.89997.90
15min122472-2247292.74795.052.3094.7097.062.33
222816-2281694.16796.25
323649-2364997.60599.70
422571-2257193.15694.99
522978-2297894.83696.81
623698-2369897.80799.89
20min122308-2230892.07094.431.4695.0697.491.49
222848-2284894.29997.43
323240-2324095.91799.10
422877-2287794.41997.29
522824-2282494.20097.23
623180-2318095.66998.84
30min122976-2297694.82794.580.6698.8498.690.71
222932-2293294.64698.82
323160-2316095.58799.83
422725-2272593.79197.71
522909-2290994.55198.63
622800-2280094.10198.33
45min122163-2216391.47293.891.3196.5499.051.32
222836-2283694.25099.48
322876-2287694.41599.72
422730-2273093.81298.77
522927-2292794.62599.75
622957-2295794.749100.03
极限122475-2247592.76093.210.9498.8499.420.99
222648-2264893.47499.75
322922-2292294.605100.96
422299-2229992.03398.03
522653-2265393.49499.67
622513-2251392.91799.25
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%
113.931632561638291638051637111633261635850.17
214.001629411628621629020.04
单位质量响应值RSD%判断
11743.3611635.860.66数据可信
供试品溶液-2022081601批-氨氯地平-醋酸盐缓冲液（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%
5min1141472-14147278.45575.9911.9378.4675.9911.93
2149207-14920782.74582.74
3151972-15197284.27884.28
4111054-11105461.58761.59
5122981-12298168.20168.20
6145443-14544380.65880.66
10min1162916-16291690.34893.742.7791.2294.582.67
2164477-16447791.21392.13
3168218-16821893.28894.22
4173937-17393796.45997.14
5173825-17382596.39797.16
6170834-17083494.73995.63
15min1164842-16484291.41692.413.1393.2994.303.14
2164146-16414691.03092.96
3173696-17369696.32698.30
4161434-16143489.52691.28
5163040-16304090.41692.25
6172656-17265695.74997.70
20min1164219-16421991.07092.331.5693.9695.241.60
2165520-16552091.79294.74
3170420-17042094.50997.55
4166466-16646692.31695.07
5163723-16372390.79593.63
6168617-16861793.50996.52
30min1169299-16929993.88793.081.1097.7997.021.12
2167749-16774993.02896.99
3169876-16987694.20798.30
4167982-16798293.15796.93
5164572-16457291.26695.11
6167628-16762892.96197.01
45min1161832-16183289.74692.672.0594.6997.642.03
2167227-16722792.73897.74
3169628-16962894.07099.21
4166942-16694292.58097.39
5165317-16531791.67996.54
6171700-17170095.219100.30
极限1169769-16976994.14894.110.84100.09100.110.85
2169512-16951294.005100.03
3171904-17190495.332101.52
4168265-16826593.31499.15
5170611-17061194.615100.49
6168172-16817293.26299.40
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