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%
19.673988739894398583983939871398700.06
29.703971739802397600.16
单位质量响应值RSD%判断
4123.064098.970.42数据可信
长期18月-供试品溶液-2022081302批-培哚普利-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%
5min146398-4639896.29593.352.5396.3093.362.53
244853-4485393.08993.09
344934-4493493.25793.26
445836-4583695.12995.13
543065-4306589.37889.38
644794-4479492.96692.97
10min147255-4725598.07496.251.3699.1497.281.37
246608-4660896.73197.77
346659-4665996.83797.87
446262-4626296.01397.07
545389-4538994.20195.19
646074-4607495.62396.66
15min146854-4685497.24295.681.8999.4097.791.88
246364-4636496.22598.33
347011-4701197.56799.68
445982-4598295.43297.56
544622-4462292.60994.65
645785-4578595.02397.12
20min145809-4580995.07394.431.8598.3197.601.83
246516-4651696.54099.72
346028-4602895.52798.72
445672-4567294.78897.97
544625-4462592.61695.68
644343-4434392.03095.18
30min145409-4540994.24393.892.4598.5498.112.41
246406-4640696.312100.56
346062-4606295.59899.86
445640-4564094.72298.96
543404-4340490.08194.18
644518-4451892.39396.57
45min145127-4512793.65792.231.6699.0097.501.66
244704-4470492.77998.10
345238-4523893.88899.21
444442-4444292.23697.53
543553-4355390.39195.49
643581-4358190.44995.65
极限144838-4483893.05891.322.3699.4497.612.31
244583-4458392.52898.88
345139-4513993.682100.05
443896-4389691.10397.42
542697-4269788.61494.72
642856-4285688.94495.15
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%
114.018297982538825138264683141827630.34
214.068301982693828560.28
单位质量响应值RSD%判断
5907.425893.030.18数据可信
长期18月-供试品溶液-2022081302批-氨氯地平-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%
5min183538-8353891.78288.222.8591.7888.222.85
279086-7908686.89186.89
379549-7954987.40087.40
481594-8159489.64789.65
576935-7693584.52884.53
681080-8108089.08289.08
10min187995-8799596.67995.241.3597.7096.221.37
286256-8625694.76995.73
385906-8590694.38495.36
487342-8734295.96296.96
584953-8495393.33794.28
687634-8763496.28397.27
15min187642-8764296.29195.401.2498.3997.441.25
287167-8716795.77097.79
387130-8713095.72997.75
486621-8662195.17097.23
584788-8478893.15695.13
687659-8765996.31098.37
20min185792-8579294.25994.051.3697.4297.151.33
287334-8733495.95399.04
385638-8563894.09097.17
486228-8622894.73897.86
584398-8439892.72795.74
684235-8423592.54895.68
30min184767-8476793.13393.272.0897.3497.412.03
287629-8762996.277100.43
385326-8532693.74797.88
484903-8490393.28297.45
582104-8210490.20794.25
684611-8461192.96197.12
45min184648-8464893.00292.101.0298.2597.281.03
284640-8464092.99398.21
383606-8360691.85797.03
484063-8406392.35997.57
582370-8237090.49995.54
683651-8365191.90797.10
极限184633-8463392.98590.931.7499.2697.131.70
283181-8318191.39097.64
383638-8363891.89298.08
482847-8284791.02397.26
580617-8061788.57394.62
681647-8164789.70595.92
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%
19.671996020141200382003920030200420.33
29.702019019950200700.85
单位质量响应值RSD%判断
2072.602069.070.13数据可信
长期18月-供试品溶液-2022081601批-培哚普利-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%
5min123752-2375297.86094.422.6497.8694.422.64
222087-2208791.00091.00
322760-2276093.77393.77
423329-2332996.11796.12
523113-2311395.22795.23
622467-2246792.56692.57
10min123654-2365497.45696.651.4898.5497.691.48
222910-2291094.39195.40
323747-2374797.84098.88
423785-2378597.99699.06
523195-2319595.56596.62
623454-2345496.63297.66
15min123307-2330796.02795.311.6998.2097.431.68
222593-2259393.08595.14
323340-2334096.16398.29
423133-2313395.31097.47
523651-2365197.44499.56
622776-2277693.83995.94
20min123248-2324895.78494.771.6499.0297.951.63
222494-2249492.67795.77
323434-2343496.55099.75
423274-2327495.89199.11
522903-2290394.36297.56
622660-2266093.36196.51
30min122676-2267693.42792.671.4297.7396.901.43
222050-2205090.84894.97
322860-2286094.18598.46
422630-2263093.23797.52
522584-2258493.04897.30
622149-2214991.25695.44
45min122184-2218491.40091.401.5896.7496.661.55
221762-2176289.66194.79
322706-2270693.55198.87
422448-2244892.48897.80
521904-2190490.24695.53
622093-2209391.02596.22
极限122319-2231991.95691.631.3198.3197.911.31
221689-2168989.36095.49
322390-2239092.24998.60
422527-2252792.81399.16
522302-2230291.88698.17
622208-2220891.49997.71
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%
114.011649361650361653031646901649311649790.14
214.061659801647271653540.54
单位质量响应值RSD%判断
11775.8011760.600.10数据可信
长期18月-供试品溶液-2022081601批-氨氯地平-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%
5min1171015-17101594.20492.072.5594.2092.072.55
2164735-16473590.74490.74
3168327-16832792.72392.72
4172282-17228294.90294.90
5165637-16563791.24191.24
6160869-16086988.61588.61
10min1175699-17569996.78498.052.2597.8399.082.23
2175115-17511596.46297.47
3181586-181586100.027101.06
4183709-183709101.196102.25
5173493-17349395.56996.58
6178400-17840098.27299.26
15min1175034-17503496.41796.821.2698.5498.931.27
2173484-17348495.56497.64
3179151-17915198.685100.83
4177011-17701197.50799.69
5176429-17642997.18699.26
6173485-17348595.56497.64
20min1175299-17529996.56396.661.5799.7699.841.57
2173505-17350595.57598.72
3178968-17896898.585101.82
4178742-17874298.460101.72
5173158-17315895.38498.54
6173126-17312695.36698.50
30min1170092-17009293.69594.461.2397.9698.721.24
2170262-17026293.78997.99
3174800-17480096.289100.62
4173251-17325195.43599.79
5171090-17109094.24598.46
6169354-16935493.28997.49
45min1167026-16702692.00692.891.8897.3198.201.86
2166773-16677391.86797.11
3172580-17258095.066100.47
4172739-17273995.153100.57
5165664-16566491.25696.52
6166965-16696591.97397.21
极限1167271-16727192.14193.131.3298.4799.471.32
2167269-16726992.14098.41
3170644-17064493.999100.46
4172672-17267295.116101.59
5169098-16909893.14899.42
6167422-16742292.22498.48
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%
19.672003920164201162013819997200910.35
29.702008420155201200.25
单位质量响应值RSD%判断
2077.662074.230.12数据可信
长期18月-供试品溶液-2022081901批-培哚普利-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%
5min123252-2325295.56493.871.4395.5693.871.43
222802-2280293.71593.71
322951-2295194.32794.33
422392-2239292.03092.03
522549-2254992.67592.68
623087-2308794.88694.89
10min123275-2327595.65996.331.2296.7297.371.19
223272-2327295.64696.69
323388-2338896.12397.17
423809-2380997.85498.88
523766-2376697.67798.71
623119-2311995.01896.07
15min123228-2322895.46695.251.4897.5997.361.46
222684-2268493.23095.33
323422-2342296.26398.38
423656-2365697.22599.33
523092-2309294.90797.02
622965-2296594.38596.49
20min122819-2281993.78594.000.9396.9797.180.92
222566-2256692.74595.88
323006-2300694.55397.74
423183-2318395.28198.47
522759-2275993.53896.71
622900-2290094.11897.28
30min122653-2265393.10292.771.3397.3396.981.30
221976-2197690.32094.49
322655-2265593.11197.35
422648-2264893.08297.33
522829-2282993.82698.03
622670-2267093.17297.38
45min122120-2212090.91291.781.1796.1797.031.13
222101-2210190.83496.01
322163-2216391.08996.36
422763-2276393.55598.84
522493-2249392.44597.70
622352-2235291.86597.11
极限121913-2191390.06191.332.8796.3397.602.72
221470-2147088.24094.42
322194-2219491.21697.50
422965-2296594.385100.71
523006-2300694.553100.83
621781-2178189.51995.78
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%
114.018306383393831958271482623829980.40
214.068324582637829410.52
单位质量响应值RSD%判断
5924.205899.080.31数据可信
长期18月-供试品溶液-2022081901批-氨氯地平-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%
5min184125-8412592.24989.762.7292.2589.762.72
282825-8282590.82490.82
383003-8300391.01991.02
477846-7784685.36485.36
580918-8091888.73288.73
682407-8240790.36590.37
10min188497-8849797.04396.311.6298.0797.311.60
285751-8575194.03295.04
389543-8954398.19099.20
488306-8830696.83497.78
588395-8839596.93297.92
686483-8648394.83595.84
15min188899-8889997.48496.122.3999.5998.182.36
284279-8427992.41894.47
390584-9058499.332101.43
487672-8767296.13998.16
587397-8739795.83797.90
687071-8707195.48097.54
20min186780-8678095.16194.851.7898.3597.991.76
284115-8411592.23895.32
388936-8893697.525100.73
486379-8637994.72197.81
586352-8635294.69197.82
686440-8644094.78897.91
30min186219-8621994.54593.842.1098.7998.032.07
282444-8244490.40694.51
387562-8756296.018100.31
484724-8472492.90697.05
586564-8656494.92499.10
685948-8594894.24898.42
45min184317-8431792.46092.801.2997.7598.041.28
282658-8265890.64195.75
385603-8560393.87099.23
485184-8518493.41098.59
585427-8542793.67798.91
684596-8459692.76697.98
极限184256-8425692.39391.642.8198.7197.912.71
280176-8017687.91994.04
385512-8551293.770100.17
483533-8353391.60097.82
586363-8636394.703100.98
681589-8158989.46895.72
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