苯磺酸左氨氯地平贝那普利胶囊片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5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%
114.834642044651144641144641934636524642550.12
214.844627324627724627520.01
单位质量响应值RSD%判断
31305.1231182.750.28数据可信
长期24月-供试品溶液-2023041621批-苯磺酸左氨氯地平-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%
5min1307250-30725068.98879.959.3668.9979.959.36
2346683-34668377.84277.84
3376981-37698184.64584.65
4397632-39763289.28289.28
5375099-37509984.22384.22
6332694-33269474.70174.70
10min1424788-42478895.38096.611.6295.5996.851.64
2428556-42855696.22696.46
3430078-43007896.56896.82
4438821-43882198.53198.80
5437849-43784998.31298.57
6421438-42143894.62894.85
15min1429559-42955996.45197.061.6396.9497.591.64
2433063-43306397.23897.76
3425749-42574995.59696.14
4440507-44050798.90999.47
5440413-44041398.88899.44
6424358-42435895.28395.79
20min1429841-42984196.51497.381.2997.3098.201.30
2434853-43485397.64098.45
3430624-43062496.69097.52
4438851-43885198.53799.40
5441099-44109999.04299.89
6426782-42678295.82796.62
30min1429579-42957996.45697.661.3697.5398.771.37
2435091-43509197.69398.80
3434915-43491597.65498.77
4440725-44072598.958100.11
5442055-44205599.257100.40
6427208-42720895.92397.00
45min1431097-43109796.79697.561.5398.1698.971.54
2434973-43497397.66799.07
3432800-43280097.17998.59
4442088-44208899.264100.72
5441462-44146299.124100.56
6424558-42455895.32896.70
60min1429011-42901196.32897.061.4697.9898.761.47
2426389-42638995.73997.43
3432999-43299997.22398.93
4438537-43853798.467100.22
5440851-44085198.986100.72
6425974-42597495.64697.30
极限1429573-42957396.45497.471.4998.3999.461.50
2434287-43428797.51399.49
3430759-43075996.72098.72
4442932-44293299.454101.50
5440441-44044198.894100.93
6426462-42646295.75697.70
苯磺酸左氨氯地平贝那普利胶囊片项目信息
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%
19.778081398090628092088078798082488085070.08
29.768068068067938068000.01
单位质量响应值RSD%判断
82754.0482663.930.08数据可信
长期24月-供试品溶液-2023041621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%
5min1305672-30567236.66231.0295.9736.6631.0295.98
220444-204442.4522.45
3664192-66419279.66279.66
461655-616557.3957.39
598827-9882711.85311.85
6401029-40102948.09948.10
10min1801460-80146096.12697.061.0696.2497.161.05
2802209-80220996.21696.22
3813273-81327397.54397.78
4820929-82092998.46198.48
5816008-81600897.87197.91
6801805-80180596.16796.31
15min1806351-80635196.71397.761.2097.1198.141.14
2815804-81580497.84698.14
3810149-81014997.16897.70
4829665-82966599.50999.83
5823045-82304598.71599.04
6805377-80537796.59697.03
20min1802660-80266096.27097.371.0596.9698.040.99
2813294-81329497.54598.13
3807390-80739096.83797.66
4824435-82443598.88299.50
5818458-81845898.16598.79
6804676-80467696.51297.23
30min1804583-80458396.50197.261.0697.4898.231.01
2812004-81200497.39198.27
3808657-80865796.98998.10
4824071-82407198.83899.75
5816307-81630797.90798.83
6800039-80003995.95696.97
45min1799478-79947895.88896.841.1197.1698.101.05
2808667-80866796.99098.16
3803494-80349496.37097.77
4821068-82106898.47899.69
5813897-81389797.61898.83
6797900-79790095.69997.00
60min1796126-79612695.48696.581.1797.0498.141.12
2805046-80504696.55698.02
3802905-80290596.29997.99
4819948-81994898.34399.85
5811931-81193197.38298.89
6795672-79567295.43297.02
极限1795321-79532195.39096.161.0297.2398.000.96
2802659-80265996.27098.02
3797532-79753295.65597.64
4814932-81493297.74299.54
5806694-80669496.75498.55
6793336-79333695.15297.03
苯磺酸左氨氯地平贝那普利胶囊片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5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%
114.834649184639924632604632054631384637030.17
214.844640484642404641440.03
单位质量响应值RSD%判断
31267.9031276.550.02数据可信
中间条件24月-供试品溶液-2023041621批-苯磺酸左氨氯地平-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%
5min1346316-34631677.68977.825.6877.6977.825.68
2335307-33530775.22075.22
3380160-38016085.28285.28
4323904-32390472.66272.66
5356962-35696280.07880.08
6338637-33863775.96775.97
10min1426918-42691895.77195.431.3296.0095.661.33
2420084-42008494.23894.46
3431548-43154896.81097.07
4421105-42110594.46794.68
5432162-43216296.94797.19
6420489-42048994.32994.56
15min1432384-43238496.99796.491.3297.5297.011.32
2424746-42474695.28495.79
3433513-43351397.25097.80
4426605-42660595.70196.20
5438661-43866198.40598.94
6424802-42480295.29695.81
20min1434692-43469297.51596.661.3598.3397.471.36
2425706-42570695.49996.29
3435806-43580697.76598.60
4425404-42540495.43196.22
5437836-43783698.22099.05
6425872-42587295.53696.33
30min1433707-43370797.29496.891.0398.4097.991.04
2428617-42861796.15297.23
3433003-43300397.13698.27
4427761-42776195.96097.03
5439422-43942298.57699.70
6429015-42901596.24197.32
45min1436190-43619097.85196.991.0999.2598.381.10
2431742-43174296.85398.22
3432545-43254597.03398.46
4425180-42518095.38196.74
5438470-43847098.36299.78
6429859-42985996.43197.80
60min1432376-43237696.99596.661.0298.6898.341.02
2427047-42704795.80097.46
3432696-43269697.06798.78
4426905-42690595.76897.42
5438041-43804198.26699.98
6428114-42811496.03997.70
极限1432119-43211996.93896.580.9198.9298.550.92
2428421-42842196.10898.06
3430965-43096596.67998.68
4426415-42641595.65897.59
5437210-43721098.080100.09
6427975-42797596.00897.96
苯磺酸左氨氯地平贝那普利胶囊片项目信息
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%
19.778083358072758068048078018074628075350.08
29.768089758066588078160.21
单位质量响应值RSD%判断
82654.5582768.030.10数据可信
中间条件24月-供试品溶液-2023041621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%
5min157811-578116.93410.4287.866.9310.4287.84
249907-499075.9865.99
3222211-22221126.65126.65
4116793-11679314.00814.01
574508-745088.9368.94
6-0.0000.00
10min1785000-78500094.14996.061.5094.1796.091.52
2791613-79161394.94294.96
3811712-81171297.35397.43
4807556-80755696.85496.90
5814516-81451697.68997.72
6795036-79503695.35395.35
15min1799783-79978395.92298.181.2896.2398.501.28
2823222-82322298.73399.04
3818520-81852098.16998.54
4818392-81839298.15498.49
5831478-83147899.724100.04
6820252-82025298.37798.66
20min1808454-80845496.96298.210.9497.5598.820.95
2819764-81976498.31998.92
3827387-82738799.23399.90
4814370-81437097.67298.30
5827690-82769099.26999.89
6815461-81546197.80398.38
30min1801491-80149196.12797.981.1197.0198.881.10
2822521-82252198.64999.54
3814822-81482297.72698.69
4814728-81472897.71598.63
5827877-82787799.292100.21
6820008-82000898.34899.22
45min1796012-79601295.47097.811.5996.6499.021.58
2833374-83337499.951101.14
3814681-81468197.70998.97
4809763-80976397.11998.33
5825375-82537598.992100.21
6814055-81405597.63498.80
60min1790574-79057494.81897.131.3696.2798.621.36
2817690-81769098.07099.56
3810891-81089197.25498.80
4807204-80720496.81298.32
5822542-82254298.652100.16
6809991-80999197.14798.61
极限1792398-79239895.03696.781.1296.7898.571.12
2811396-81139697.31599.10
3806433-80643396.72098.56
4803740-80374096.39798.19
5819795-81979598.322100.13
6807916-80791696.89898.65
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