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%
114.078216681795821318203881588819440.31
213.878076281721812420.84
单位质量响应值RSD%判断
5824.025857.390.41数据可信
供试品溶液-25090901-1批-氨氯地平-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%
5min152384-5238480.63981.764.0480.6481.764.04
251364-5136479.06979.07
355460-5546085.37485.37
454110-5411083.29683.30
555174-5517484.93484.93
650180-5018077.24677.25
10min172621-72621111.791112.971.02112.69113.881.02
272884-72884112.196113.07
374548-74548114.758115.71
473071-73071112.484113.41
573158-73158112.618113.56
674045-74045113.983114.84
15min176477-76477117.727118.480.84119.87120.640.81
276856-76856118.311120.44
376917-76917118.405120.63
476842-76842118.289120.46
576483-76483117.736119.93
678218-78218120.407122.53
20min177599-77599119.454119.521.18122.90123.001.13
278361-78361120.627124.07
377536-77536119.357122.90
476550-76550117.840121.33
576835-76835118.278121.78
678984-78984121.586125.05
30min177594-77594119.447120.821.36124.22125.631.31
278957-78957121.545126.32
378402-78402120.691125.56
477152-77152118.766123.57
578673-78673121.108125.93
680156-80156123.391128.20
45min177796-77796119.758120.671.19125.86126.821.15
278383-78383120.661126.79
378444-78444120.755126.96
477596-77596119.450125.57
577959-77959120.009126.17
680164-80164123.403129.59
极限178430-78430120.734121.431.20128.16128.931.16
279582-79582122.507129.98
379505-79505122.388129.94
477507-77507119.313126.76
578335-78335120.587128.08
679954-79954123.080130.64
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%
114.078255281784819088240482121821540.40
213.878150881674815910.15
单位质量响应值RSD%判断
5838.955882.550.53数据可信
供试品溶液-25090901-2批-氨氯地平-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%
5min19272-927214.22413.207.9414.2213.207.95
28757-875713.43413.43
37329-732911.24411.24
49035-903513.86113.86
58460-846012.97912.98
68784-878413.47613.48
10min145986-4598670.54871.366.0170.7171.516.00
247138-4713872.31672.46
343833-4383367.24567.37
448979-4897975.14075.29
543049-4304966.04366.19
650123-5012376.89577.04
15min170358-70358107.938110.201.24108.88111.141.25
271639-71639109.903110.86
371676-71676109.960110.83
473056-73056112.077113.07
572032-72032110.506111.38
672252-72252110.844111.85
20min174940-74940114.967117.501.17117.11119.671.14
276888-76888117.956120.13
377274-77274118.548120.64
477077-77077118.246120.48
577151-77151118.359120.47
676230-76230116.946119.18
30min177752-77752119.281121.851.64122.70125.321.60
280444-80444123.411126.90
380784-80784123.933127.34
480462-80462123.439126.99
578898-78898121.039124.46
678231-78231120.016123.55
45min180402-80402123.347122.730.49128.09127.550.43
279717-79717122.296127.15
380394-80394123.334128.12
479823-79823122.458127.38
580206-80206123.046127.81
679456-79456121.895126.76
极限180753-80753123.885124.050.68130.00130.240.67
281362-81362124.819131.03
381219-81219124.600130.76
481397-81397124.873131.15
580178-80178123.003129.14
680272-80272123.147129.37
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
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%
114.078169982219818628188482001819330.24
213.878201181850819300.14
单位质量响应值RSD%判断
5823.245906.991.01数据可信
供试品溶液-25090901-3批-氨氯地平-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%
5min19498-949814.56114.483.9414.5614.473.95
29765-976514.97014.97
39957-995715.26415.26
49324-932414.29414.29
58997-899713.79313.79
69114-911413.97213.97
10min118202-1820227.90428.558.0728.0728.718.04
219664-1966430.14630.31
320198-2019830.96431.13
419017-1901729.15429.31
518764-1876428.76628.92
615907-1590724.38624.54
15min134828-3482853.39354.817.7553.8655.297.74
238131-3813158.45658.96
339072-3907259.89960.41
436332-3633255.69856.18
534824-3482453.38753.86
631325-3132548.02248.45
20min152073-5207379.83080.476.4880.9081.566.48
256034-5603485.90287.05
355847-5584785.61686.79
453041-5304181.31482.42
551081-5108178.30979.38
646886-4688671.87872.84
30min176069-76069116.617115.351.40118.57117.341.40
274088-74088113.580115.69
375211-75211115.301117.43
476766-76766117.685119.69
575169-75169115.237117.17
674170-74170113.706115.46
45min181918-81918125.584121.032.08128.83124.292.02
277498-77498118.808122.17
377958-77958119.513122.92
479744-79744122.251125.56
578409-78409120.204123.42
678153-78153119.812122.83
极限183097-83097127.391123.711.85132.03128.321.82
279182-79182121.389126.08
380387-80387123.236127.98
481873-81873125.515130.19
579909-79909122.504127.06
679709-79709122.197126.55
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