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4000
标示量(mg)5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%
19.721955719586197901964719813196790.60
29.751948319392194380.34
单位质量响应值RSD%判断
2024.591993.641.09数据可信
供试品溶液-25090901-1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%
5min122258-2225894.52797.421.8594.5397.421.85
223113-2311398.15998.16
323069-2306997.97297.97
422692-2269296.37196.37
522994-2299497.65397.65
623503-2350399.81599.81
10min123299-2329998.94899.571.02100.00100.651.03
223415-2341599.441100.53
323344-2334499.140100.23
423277-2327798.85599.93
523415-2341599.441100.53
623918-23918101.577102.69
15min122809-2280996.86898.561.6699.02100.751.65
223571-23571100.104102.30
322860-2286097.08499.27
423067-2306797.963100.13
523176-2317698.426100.62
623762-23762100.915103.15
20min122740-2274096.57497.631.8199.80100.911.79
223479-2347999.713103.02
322639-2263996.14699.41
422653-2265396.20599.46
522873-2287397.139100.42
623544-2354499.989103.35
30min122469-2246995.42496.651.1499.72101.021.15
222956-2295697.492101.91
322808-2280896.863101.20
422456-2245695.36899.69
522754-2275496.634101.00
623099-2309998.099102.57
45min121939-2193993.17395.021.8698.53100.461.82
222292-2229294.672100.17
322618-2261896.056101.47
421938-2193893.16898.55
522434-2243495.275100.71
623016-2301697.747103.31
极限121951-2195193.22494.541.3299.62101.041.31
222406-2240695.156101.71
322524-2252495.657102.14
421971-2197193.30999.73
522093-2209393.827100.32
622623-2262396.078102.72
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4000
标示量(mg)5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%
19.721949519572195661970319468195610.47
29.751964519398195220.90
单位质量响应值RSD%判断
2012.452002.260.36数据可信
供试品溶液-25090901-2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%
5min17381-738131.37231.803.1931.3731.803.19
27675-767532.62232.62
37077-707730.08030.08
47694-769432.70332.70
57422-742231.54631.55
67636-763632.45632.46
10min118945-1894580.52484.406.7180.8784.756.69
221020-2102089.34389.71
319737-1973783.89084.22
420765-2076588.26088.62
517709-1770975.27075.62
620968-2096889.12289.48
15min123596-23596100.292100.700.37101.54102.000.39
223658-23658100.556101.91
323835-23835101.308102.57
423705-23705100.756102.10
523626-23626100.420101.61
623736-23736100.888102.24
20min123073-2307398.07099.541.33100.43101.951.32
223523-2352399.982102.45
323696-23696100.718103.11
423816-23816101.228103.69
523308-2330899.068101.37
623100-2310098.184100.66
30min122842-2284297.08898.641.40100.53102.151.39
223295-2329599.013102.60
323696-23696100.718104.23
423422-2342299.553103.14
522954-2295497.564100.97
623028-2302897.878101.44
45min123040-2304097.92997.140.91102.46101.750.89
222754-2275496.714101.40
323090-2309098.142102.77
422966-2296697.615102.31
522578-2257895.966100.45
622698-2269896.476101.13
极限122553-2255395.85996.520.90101.47102.210.89
222994-2299497.734103.49
322721-2272196.573102.29
422864-2286497.181102.96
522685-2268596.420101.97
622432-2243295.345101.07
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4000
标示量(mg)5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%
19.721929619670195191948819389194720.73
29.751958619479195320.39
单位质量响应值RSD%判断
2003.292003.280.01数据可信
供试品溶液-25090901-3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%
5min14869-486920.73721.102.9620.7421.102.95
25130-513021.84921.85
35000-500021.29521.30
44984-498421.22721.23
55029-502921.41921.42
64709-470920.05620.06
10min19481-948140.38040.414.4540.6140.654.44
29951-995142.38142.62
39855-985541.97242.21
49617-961740.95941.19
59213-921339.23839.48
68818-881837.55637.78
15min113999-1399959.62261.084.8860.3061.774.87
215051-1505164.10264.82
315264-1526465.00965.71
414395-1439561.30862.00
513873-1387359.08559.76
613473-1347357.38258.02
20min118187-1818777.45879.103.8878.8080.463.88
219241-1924181.94783.37
319528-1952883.17084.60
418551-1855179.00980.38
518367-1836778.22579.56
617556-1755674.77176.05
30min123284-2328499.16798.301.99101.37100.541.90
222776-2277697.00399.34
322755-2275596.91499.26
423409-2340999.699101.95
522534-2253495.97298.17
623719-23719101.019103.13
45min123524-23524100.18997.531.76103.49100.861.70
222681-2268196.598100.01
322653-2265396.47999.91
423265-2326599.086102.44
522492-2249295.79399.06
622783-2278397.033100.26
极限123281-2328199.15497.911.21103.57102.331.13
222547-2254796.028100.52
322847-2284797.305101.80
423222-2322298.902103.36
522901-2290197.535101.87
623142-2314298.562102.87
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