阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.572758932760892751652754902755982756470.14
210.712775552781152778350.15
单位质量响应值RSD%判断
26078.2425941.640.38数据可信
供试品溶液-6042801批-阿齐沙坦-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%
5min1174951-17495160.35657.8212.9960.3657.8212.99
2165583-16558357.12457.12
3197133-19713368.00868.01
4171796-17179659.26759.27
5166238-16623857.35057.35
6129950-12995044.83144.83
10min1265459-26545991.58095.203.0391.9195.523.03
2286199-28619998.73599.05
3271193-27119393.55893.94
4281885-28188597.24697.58
5281612-28161297.15297.47
6269295-26929592.90393.15
15min1280933-28093396.91897.991.4697.7698.841.47
2288897-28889799.665100.53
3280905-28090596.90897.81
4287040-28704099.02599.89
5287321-28732199.12299.98
6279233-27923396.33197.10
20min1276578-27657895.41597.821.8796.8099.221.85
2282857-28285797.58299.00
3280201-28020196.66598.10
4287079-28707999.038100.46
5291690-291690100.629102.04
6282939-28293997.61098.91
30min1284228-28422898.05598.371.2399.97100.311.22
2289563-28956399.895101.86
3281211-28121197.01498.99
4289368-28936899.828101.80
5283253-28325397.71899.69
6283182-28318297.69499.54
45min1285792-28579298.59499.050.99101.05101.541.02
2288897-28889799.665102.18
3287842-28784299.301101.81
4288727-28872799.607102.13
5289487-28948799.869102.38
6281953-28195397.27099.66
60min1284546-28454698.16498.750.63101.17101.790.67
2287972-28797299.346102.42
3287622-28762299.226102.29
4287495-28749599.182102.26
5286193-28619398.733101.80
6283640-28364097.852100.78
极限1283488-28348897.79999.751.08101.35103.331.05
2291808-291808100.670104.29
3288207-28820799.427103.04
4289741-28974199.957103.59
5289628-28962899.918103.53
6291979-291979100.729104.20
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.437496174582741077463474517745600.42
215.547500974926749680.08
单位质量响应值RSD%判断
4832.154824.200.12数据可信
供试品溶液-6042801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%
5min159964-5996480.52180.823.0480.5280.823.05
258559-5855978.63578.63
362926-6292684.49984.50
460519-6051981.26781.27
561257-6125782.25882.26
657890-5789077.73677.74
10min169880-6988093.83793.393.2894.2893.843.27
270092-7009294.12294.56
371506-7150696.02096.49
469588-6958893.44593.90
571068-7106895.43295.89
665151-6515187.48787.92
15min172754-7275497.69693.047.8998.6694.007.80
271823-7182396.44697.41
358988-5898879.21180.21
469171-6917192.88593.86
574238-7423899.689100.68
668732-6873292.29593.21
20min171122-7112295.50592.655.7597.0294.135.66
260948-6094881.84383.34
370928-7092895.24496.69
470001-7000193.99995.49
570829-7082995.11196.65
670137-7013794.18295.61
30min172847-7284797.82198.373.1499.86100.363.06
275421-75421101.278103.23
375960-75960102.001103.97
469807-6980793.73995.75
573671-7367198.928101.00
671809-7180996.42798.38
45min173640-7364098.88694.675.07101.4797.224.97
265196-6519687.54790.06
370962-7096295.29097.83
467061-6706190.05292.58
573616-7361698.854101.47
672532-7253297.39899.89
60min166368-6636889.12196.184.8792.2699.264.72
271012-7101295.35798.36
376492-76492102.716105.78
469816-6981693.75196.78
573995-7399599.363102.53
672087-7208796.80199.83
极限170515-7051594.69097.683.0098.32101.282.93
271872-7187296.512100.04
376319-76319102.483106.12
470992-7099295.33098.88
574199-7419999.637103.36
672536-7253697.404100.97
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.572773672770342767112760892781522770710.28
210.712782822763512773160.50
单位质量响应值RSD%判断
26212.9625893.180.87数据可信
供试品溶液-6042901批-阿齐沙坦-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%
5min1168263-16826357.95458.3911.3157.9558.3811.31
2157494-15749454.24554.24
3157612-15761254.28654.29
4200313-20031368.99368.99
5183795-18379563.30463.30
6149622-14962251.53451.53
10min1275306-27530694.82291.395.0795.1491.725.06
2272639-27263993.90494.21
3243446-24344683.84984.15
4278627-27862795.96696.35
5255718-25571888.07688.43
6266296-26629691.71992.01
15min1284505-28450597.99194.634.0098.8495.464.00
2280805-28080596.71697.54
3254466-25446687.64588.41
4281142-28114296.83297.75
5271041-27104193.35394.19
6276560-27656095.25496.05
20min1281719-28171997.03195.452.9398.4296.812.94
2282978-28297897.46598.83
3261863-26186390.19291.45
4280654-28065496.66498.12
5274099-27409994.40795.77
6281504-28150496.95798.28
30min1281303-28130396.88895.952.6398.8297.842.65
2279892-27989296.40298.30
3264844-26484491.21992.97
4285518-28551898.340100.33
5277077-27707795.43297.32
6282861-28286197.42499.29
45min1286662-28666298.73496.272.19101.2098.692.20
2279921-27992196.41298.85
3269781-26978192.91995.18
4281253-28125396.87199.41
5275427-27542794.86497.28
6284011-28401197.821100.23
60min1284999-28499998.16196.672.26101.1899.632.29
2282281-28228197.225100.20
3268548-26854892.49595.27
4284537-28453798.002101.08
5279060-27906096.11599.06
6284581-28458198.017100.97
极限1291120-291120100.269100.950.88103.83104.450.80
2289303-28930399.643103.16
3296101-296101101.985105.28
4294169-294169101.319104.94
5292838-292838100.861104.34
6295114-295114101.645105.14
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.437493574827746937480274017746550.50
215.547497674537747560.42
单位质量响应值RSD%判断
4838.304810.550.41数据可信
供试品溶液-6042901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%
5min152911-5291171.10675.226.7971.1175.226.79
254780-5478073.61873.62
353807-5380772.31072.31
461251-6125182.31482.31
552787-5278770.94070.94
660300-6030081.03681.04
10min166820-6682089.79890.063.7690.1990.473.76
270358-7035894.55394.96
364216-6421686.29986.70
467263-6726390.39490.85
564219-6421986.30386.70
669192-6919292.98693.44
15min168893-6889392.58493.322.8093.4894.242.80
272226-7222697.06398.00
368517-6851792.07992.96
469088-6908892.84693.81
566794-6679489.76390.64
671116-7111695.57296.54
20min166983-6698390.01793.454.0591.4394.884.03
274139-7413999.634101.11
368413-6841391.93993.33
468064-6806491.47092.95
567761-6776191.06392.44
671845-7184596.55198.05
30min168269-6826991.74692.024.2593.6593.984.18
273712-7371299.060101.09
368816-6881692.48194.38
468232-6823291.69693.68
566762-6676289.72091.60
665058-6505887.43089.46
45min170570-7057094.83894.892.9797.2697.362.96
273529-7352998.814101.39
370529-7052994.78397.20
470723-7072395.04397.54
567027-6702790.07692.45
671297-7129795.81598.33
60min170593-7059394.86991.986.1697.8194.976.04
273388-7338898.625101.75
368880-6888092.56795.51
468751-6875192.39395.41
560738-6073881.62584.50
668312-6831291.80394.86
极限168551-6855192.12494.343.0595.6097.853.01
270808-7080895.15898.83
372829-7282997.874101.33
470383-7038394.58698.12
566941-6694189.96193.29
671704-7170496.36299.92
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.572781492775942777582786202777932779830.15
210.712781292791732786510.27
单位质量响应值RSD%判断
26299.2426017.830.77数据可信
供试品溶液-6043001批-阿齐沙坦-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%
5min1170312-17031258.42347.1619.7758.4247.1619.77
2131293-13129345.03845.04
3118503-11850340.65140.65
4135394-13539446.44546.44
5167837-16783757.57457.57
6101565-10156534.84034.84
10min1270113-27011392.65888.953.4792.9889.213.50
2252517-25251786.62286.87
3245858-24585884.33884.56
4266129-26612991.29191.55
5262861-26286190.17090.49
6258264-25826488.59388.79
15min1275035-27503594.34693.312.1395.1994.072.13
2267729-26772991.84092.57
3263797-26379790.49191.19
4279589-27958995.90896.67
5270459-27045992.77793.60
6275533-27553394.51795.20
20min1278408-27840895.50394.921.7796.8796.201.76
2273972-27397293.98295.22
3271384-27138493.09494.29
4283231-28323197.15898.46
5272267-27226793.39794.73
6281018-28101896.39997.61
30min1279171-27917195.76594.920.9297.6696.720.94
2276643-27664394.89896.66
3272793-27279393.57795.29
4278062-27806295.38597.22
5274748-27474894.24896.10
6278897-27889795.67197.42
45min1280164-28016496.10695.081.4198.5397.411.39
2277127-27712795.06497.35
3272939-27293993.62795.86
4280255-28025596.13798.50
5271984-27198493.30095.68
6280653-28065396.27398.55
60min1281849-28184996.68495.121.3799.6497.981.37
2275523-27552394.51497.33
3274119-27411994.03296.79
4279696-27969695.94598.85
5272422-27242293.45096.35
6280166-28016696.10698.92
极限1285527-28552797.94597.931.08101.44101.321.04
2283150-28315097.130100.47
3285020-28502097.771101.05
4286464-28646498.267101.70
5281973-28197396.726100.14
6290757-29075799.739103.09
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.437497474746750467537074537749350.43
215.547497274756748640.21
单位质量响应值RSD%判断
4856.454817.500.57数据可信
供试品溶液-6043001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%
5min155061-5506173.80476.284.6273.8076.284.63
260845-6084581.55781.56
354838-5483873.50573.51
456215-5621575.35175.35
559562-5956279.83779.84
654949-5494973.65473.65
10min164104-6410485.92588.445.5986.3488.865.56
270189-7018994.08294.53
365434-6543487.70888.12
463465-6346585.06985.49
561882-6188282.94783.39
670805-7080594.90895.32
15min163018-6301884.47092.444.8485.3693.354.82
271025-7102595.20296.18
368639-6863992.00492.90
469395-6939593.01893.91
568763-6876392.17093.07
672926-7292697.75198.69
20min167217-6721790.09893.585.4291.4595.015.37
272686-7268697.42998.93
367480-6748090.45191.86
472045-7204596.57097.98
564942-6494287.04988.47
674527-7452799.896101.38
30min168808-6880892.23191.975.8194.0993.925.75
272235-7223596.82498.87
363459-6345985.06186.97
470842-7084294.95796.90
564036-6403685.83487.73
672316-7231696.93398.97
45min168483-6848391.79592.332.2594.1694.792.25
270694-7069494.75997.34
369984-6998493.80796.19
468502-6850291.82194.29
566255-6625588.80991.19
669390-6939093.01195.58
60min169254-6925492.82992.814.3895.7195.794.33
271264-7126495.52398.63
368274-6827491.51594.42
467403-6740390.34793.33
565322-6532287.55890.43
673943-7394399.114102.20
极限167650-6765090.67989.5410.2394.0793.039.95
272599-7259997.312100.95
368351-6835191.61895.03
467175-6717590.04293.53
553573-5357371.81075.17
671446-7144695.76799.41
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