氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.069116019128169105419112029132469118810.13
214.129112669092969102810.16
单位质量响应值RSD%判断
64856.4064467.490.43数据可信
长期24月-供试品溶液-2023101921批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1747361-74736183.25074.5712.4283.2574.5812.43
2557314-55731462.08162.08
3576825-57682564.25464.25
4690260-69026076.89076.89
5697319-69731977.67677.68
6747782-74778283.29783.30
10min1889027-88902799.031100.541.1899.28100.771.16
2918995-918995102.369102.56
3901402-901402100.409100.60
4895453-89545399.74799.98
5901011-901011100.366100.60
6909725-909725101.337101.59
15min1884170-88417098.490100.011.4199.04100.541.38
2920367-920367102.522103.02
3898800-898800100.120100.61
4888094-88809498.92799.46
5898016-898016100.032100.57
6897363-89736399.959100.51
20min1878621-87862197.87299.381.3898.71100.211.35
2913636-913636101.772102.57
3896101-89610199.819100.61
4883100-88310098.37199.20
5891859-89185999.346100.18
6889841-88984199.12299.98
30min1874940-87494097.46299.071.5098.60100.201.47
2913443-913443101.751102.86
3891427-89142799.298100.39
4880289-88028998.05899.18
5890047-89004799.145100.28
6886326-88632698.73099.88
45min1870129-87012996.92698.411.4698.3599.831.44
2906934-906934101.026102.44
3883873-88387398.45799.85
4874061-87406197.36498.78
5885203-88520398.605100.03
6880592-88059298.09199.54
60min1870319-87031996.94798.301.3298.67100.011.29
2903810-903810100.678102.39
3884366-88436698.512100.20
4875480-87548097.52299.23
5882159-88215998.26699.99
6878441-87844197.85299.59
极限1866985-86698596.57698.111.4798.59100.121.44
2902995-902995100.587102.60
3884887-88488798.570100.55
4870506-87050696.96898.97
5882585-88258598.313100.33
6876447-87644797.63099.66
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.948263138263338259288254148267288261430.07
29.948257308250308253800.06
单位质量响应值RSD%判断
83112.9883036.220.07数据可信
长期24月-供试品溶液-2023101921批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115022-11502213.73515.48187.6813.7315.47187.70
2-0.0000.00
39496-94961.1341.13
4618296-61829673.83173.83
530320-303203.6213.62
64446-44460.5310.53
10min1848582-848582101.33099.311.54101.3799.351.60
2828852-82885298.97498.97
3819209-81920997.82297.83
4846081-846081101.031101.25
5827448-82744898.80698.82
6819710-81971097.88297.88
15min1848659-848659101.339100.200.88101.68100.550.92
2841797-841797100.520100.82
3827662-82766298.83299.13
4844013-844013100.784101.31
5836634-83663499.903100.21
6836207-83620799.852100.15
20min1844489-844489100.84199.970.71101.49100.620.75
2839677-839677100.266100.86
3827914-82791498.86299.46
4840414-840414100.354101.18
5837953-837953100.061100.67
6832775-83277599.442100.04
30min1842421-842421100.59499.550.82101.55100.500.86
2837474-837474100.003100.90
3824233-82423398.42299.31
4838071-838071100.075101.20
5831300-83130099.266100.17
6828676-82867698.95399.85
45min1840150-840150100.32399.250.90101.58100.490.95
2834122-83412299.603100.80
3820613-82061397.99099.18
4837643-837643100.024101.45
5827117-82711798.76799.97
6827220-82722098.77999.97
60min1840999-840999100.42499.180.97101.98100.721.01
2832980-83298099.467100.96
3818843-81884397.77999.26
4836861-83686199.930101.66
5827799-82779998.848100.35
6825983-82598398.631100.12
极限1837062-83706299.95498.810.87101.81100.650.90
2830548-83054899.176100.97
3816699-81669997.52399.30
4831149-83114999.248101.28
5826690-82669098.716100.51
6822752-82275298.245100.03
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.069127379111959129479127809137629126840.11
214.129077839096499087160.15
单位质量响应值RSD%判断
64913.5164356.660.61数据可信
长期24月-供试品溶液-2023102021批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1621247-62124769.23278.939.2469.2378.939.24
2721794-72179480.43780.44
3731027-73102781.46681.47
4741280-74128082.60882.61
5640006-64000671.32271.32
6794122-79412288.49788.50
10min1885310-88531098.65999.862.9098.87100.102.91
2915079-915079101.976102.22
3883813-88381398.49298.74
4899397-899397100.229100.48
5859663-85966395.80196.01
6933449-933449104.023104.29
15min1884013-88401398.51499.212.5899.0299.752.59
2908909-908909101.289101.84
3882043-88204398.29598.83
4887094-88709498.85899.41
5856846-85684695.48795.99
6922609-922609102.815103.39
20min1879309-87930997.99098.702.4198.7999.542.42
2903294-903294100.663101.51
3880360-88036098.10798.94
4880941-88094198.17299.02
5854528-85452895.22896.02
6915681-915681102.043102.93
30min1874658-87465897.47298.232.3798.5699.362.39
2898402-898402100.118101.27
3876100-87610097.63298.76
4878922-87892297.94799.09
5850270-85027094.75495.83
6910412-910412101.456102.65
45min1868800-86880096.81997.822.3898.2099.242.39
2897175-89717599.981101.43
3873573-87357397.35198.77
4873891-87389197.38698.82
5847677-84767794.46595.82
6905623-905623100.922102.42
60min1868947-86894796.83597.572.5598.5199.292.56
2895240-89524099.765101.52
3872123-87212397.18998.90
4866624-86662496.57698.30
5843888-84388894.04395.68
6906381-906381101.007102.81
极限1865213-86521396.41997.442.3598.3999.452.37
2891367-89136799.334101.39
3871658-87165897.13799.14
4870179-87017996.97398.99
5844634-84463494.12696.05
6903060-903060100.637102.74
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.948275158251258280508268268282608271550.16
29.948227028242618234820.14
单位质量响应值RSD%判断
83214.7982845.270.32数据可信
长期24月-供试品溶液-2023102021批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1563354-56335467.30736.9783.1867.3136.9783.17
2180331-18033121.54521.55
3682644-68264481.55981.56
47595-75950.9070.91
5226198-22619827.02527.03
6196545-19654523.48223.48
10min1844388-844388100.884100.041.25101.09100.161.23
2826591-82659198.75798.82
3829633-82963399.12199.37
4846801-846801101.172101.17
5848989-848989101.433101.51
6827778-82777898.89998.97
15min1845937-845937101.069100.521.45101.57100.931.41
2835510-83551099.823100.18
3828752-82875299.01699.56
4857992-857992102.509102.82
5851101-851101101.686102.07
6828857-82885799.02899.40
20min1842211-842211100.624100.201.28101.43100.911.24
2832294-83229499.439100.10
3826959-82695998.80199.64
4853871-853871102.017102.63
5847026-847026101.199101.89
6829681-82968199.12699.79
30min1840885-840885100.46599.961.35101.57100.981.31
2829619-82961999.119100.08
3823717-82371798.41499.55
4852361-852361101.836102.76
5845454-845454101.011102.01
6827926-82792698.91799.88
45min1837475-837475100.05899.581.41101.47100.901.36
2831435-83143599.336100.59
3820088-82008897.98099.41
4850066-850066101.562102.79
5840982-840982100.477101.77
6820979-82097998.08799.35
60min1838467-838467100.17699.431.23101.89101.041.20
2828574-82857498.994100.55
3819992-81999297.96999.69
4845268-845268100.989102.52
5838966-838966100.236101.83
6821923-82192398.20099.75
极限1832417-83241799.45399.041.44101.47100.951.39
2824618-82461898.522100.37
3815149-81514997.39099.41
4846156-846156101.095102.93
5837172-837172100.021101.92
6817991-81799197.73099.58
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.069145579113499138019113119118879125810.17
214.129108929110099109500.01
单位质量响应值RSD%判断
64906.1964514.870.43数据可信
长期24月-供试品溶液-2023102121批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1590002-59000265.67256.2523.7965.6756.2523.80
2548752-54875261.08161.08
3545936-54593660.76860.77
4283746-28374631.58331.58
5606218-60621867.47767.48
6457505-45750550.92450.92
10min1845539-84553994.11695.781.6894.3195.951.68
2850328-85032894.64994.83
3885128-88512898.52398.70
4853409-85340994.99295.09
5867586-86758696.57096.77
6861162-86116295.85596.01
15min1842824-84282493.81495.301.2794.2995.761.24
2846334-84633494.20494.67
3855109-85510995.18195.66
4869820-86982096.81997.20
5867134-86713496.52097.01
6856080-85608095.28995.73
20min1837543-83754393.22694.611.1993.9995.351.16
2844455-84445593.99594.75
3844853-84485394.04094.80
4863987-86398796.16996.84
5859721-85972195.69596.48
6849275-84927594.53295.26
30min1836133-83613393.06994.181.0794.1195.211.04
2841618-84161893.68094.71
3843338-84333893.87194.92
4860112-86011295.73896.70
5853915-85391595.04896.12
6841678-84167893.68694.70
45min1831195-83119592.51993.761.2693.8495.071.22
2834426-83442692.87994.19
3835875-83587593.04094.37
4857647-85764795.46496.71
5851909-85190994.82596.18
6843226-84322693.85995.15
60min1832604-83260492.67693.761.1594.2795.351.12
2837462-83746293.21794.81
3837063-83706393.17394.78
4856129-85612995.29596.83
5852727-85272794.91696.55
6837969-83796993.27394.85
极限1832691-83269192.68693.721.0794.5695.591.04
2837561-83756193.22895.10
3836071-83607193.06294.95
4857119-85711995.40597.22
5847579-84757994.34396.27
6840922-84092293.60295.45
氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.948278188252708272558259728254548263540.14
29.948259848254328257080.05
单位质量响应值RSD%判断
83134.2183069.220.06数据可信
长期24月-供试品溶液-2023102121批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195178-9517811.36215.8187.4911.3615.8187.50
2313386-31338637.40937.41
3230162-23016227.47527.47
4-0.0000.00
582539-825399.8539.85
673626-736268.7898.79
10min1846004-846004100.989100.410.64101.02100.450.63
2841422-841422100.442100.55
3835370-83537099.72099.80
4842727-842727100.598100.60
5847022-847022101.111101.14
6834253-83425399.58699.61
15min1857366-857366102.345101.440.96102.68101.790.93
2845449-845449100.923101.34
3839663-839663100.232100.61
4855652-855652102.141102.44
5857919-857919102.411102.74
6842782-842782100.604100.93
20min1858745-858745102.510101.301.05103.15101.951.04
2851409-851409101.634102.35
3836813-83681399.892100.57
4850525-850525101.529102.14
5855241-855241102.092102.73
6838976-838976100.150100.78
30min1853292-853292101.859101.151.28102.81102.111.25
2843054-843054100.637101.66
3836391-83639199.842100.82
4857302-857302102.338103.25
5859444-859444102.593103.54
6834691-83469199.639100.57
45min1858713-858713102.506100.671.21103.76101.941.19
2839626-839626100.228101.55
3828467-82846798.896100.18
4846157-846157101.007102.23
5848177-848177101.248102.50
6839073-839073100.162101.39
60min1851235-851235101.613100.491.03103.18102.051.01
2839297-839297100.188101.81
3831008-83100899.199100.78
4844864-844864100.853102.38
5850925-850925101.576103.13
6833537-83353799.501101.03
极限1849874-849874101.451100.261.05103.32102.131.04
2841421-841421100.442102.37
3828239-82823998.868100.74
4844081-844081100.759102.58
5845809-845809100.966102.83
6830121-83012199.093100.92
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