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%
110.952853182850302849672844702847972849160.11
211.022849862851042850450.03
单位质量响应值RSD%判断
26019.7325866.150.42数据可信
中间条件12月-供试品溶液-2023101221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%
5min1107785-10778537.28034.6714.0137.2834.6714.01
296141-9614133.25333.25
374109-7410925.63325.63
4113580-11358039.28539.28
5103064-10306435.64835.65
6106784-10678436.93436.93
10min1258898-25889889.54785.053.3989.7585.243.41
2239677-23967782.89983.08
3235929-23592981.60381.74
4251475-25147586.98087.20
5243097-24309784.08284.28
6246221-24622185.16285.37
15min1282008-28200897.54094.022.2298.2494.692.21
2270054-27005493.40694.05
3271783-27178394.00494.60
4265896-26589691.96792.67
5266395-26639592.14092.81
6274868-27486895.07195.75
20min1287453-28745399.42496.172.11100.6797.362.11
2275935-27593595.44096.60
3276331-27633195.57796.69
4272225-27222594.15695.37
5273612-27361294.63695.81
6282700-28270097.78098.99
30min1281783-28178397.46295.771.6199.2697.491.60
2276664-27666495.69297.39
3278910-27891096.46998.12
4271990-27199094.07595.81
5271273-27127393.82795.53
6280720-28072097.09598.84
45min1286472-28647299.08496.432.02101.4298.682.01
2279825-27982596.78599.01
3280003-28000396.84799.03
4272679-27267994.31496.57
5271772-27177294.00096.22
6281999-28199997.53799.83
60min1290374-290374100.43496.422.51103.3299.212.49
2276994-27699495.80698.57
3278718-27871896.40299.13
4274777-27477795.03997.82
5269865-26986593.34096.09
6281955-28195597.522100.35
极限1279883-27988396.80599.591.87100.25102.921.78
2288156-28815699.667102.96
3292908-292908101.310104.57
4284444-28444498.383101.69
5287817-28781799.549102.81
6294484-294484101.855105.23
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(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777015069912702677013369802700530.28
214.776983770208700220.38
单位质量响应值RSD%判断
4742.924740.830.04数据可信
中间条件12月-供试品溶液-2023101221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%
5min147374-4737464.77363.508.7864.7763.508.79
238606-3860652.78552.78
348371-4837166.13666.14
449895-4989568.22068.22
545786-4578662.60262.60
648613-4861366.46766.47
10min160687-6068782.97584.185.9583.3484.535.96
255657-5565776.09876.39
366986-6698691.58891.96
462340-6234085.23585.61
561079-6107983.51183.86
662640-6264085.64686.01
15min162039-6203984.82488.364.9585.6489.184.95
261798-6179884.49485.21
370249-7024996.04996.93
463445-6344586.74687.60
563916-6391687.39088.20
666303-6630390.65491.50
20min163554-6355486.89590.345.1288.1991.655.11
263401-6340186.68687.87
372062-7206298.52899.94
464583-6458388.30289.64
564790-6479088.58589.88
668041-6804193.03094.38
30min162256-6225685.12190.044.7086.9091.864.69
263542-6354286.87988.55
370769-7076996.76098.72
465687-6568789.81291.64
564928-6492888.77490.56
667944-6794492.89894.76
45min165467-6546789.51191.613.4991.7693.933.52
265447-6544789.48491.63
371063-7106397.16299.66
465881-6588190.07792.40
565552-6555289.62791.91
668620-6862093.82296.20
60min165948-6594890.16991.444.1892.9194.264.19
264179-6417987.75090.40
371341-7134197.542100.58
466999-6699991.60694.43
564109-6410987.65490.43
668691-6869193.91996.82
极限163883-6388387.34592.214.5190.5995.544.50
266126-6612690.41293.55
372470-7247099.086102.66
466444-6644490.84794.18
566256-6625690.59093.86
669482-6948295.00098.43
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%
110.952848852849492848482849532850062849280.03
211.022850342849932850140.02
单位质量响应值RSD%判断
26020.8225863.340.43数据可信
中间条件12月-供试品溶液-2024010621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%
5min1124049-12404942.90741.178.5342.9141.178.52
2101872-10187235.23635.24
3129632-12963244.83844.84
4126864-12686443.88143.88
5115258-11525839.86639.87
6116465-11646540.28440.28
10min1252661-25266187.39384.924.6387.6385.144.63
2228915-22891579.17979.37
3242113-24211383.74483.99
4248260-24826085.87086.11
5239377-23937782.79883.02
6261691-26169190.51690.74
15min1278186-27818696.22293.354.6396.9594.054.62
2255818-25581888.48589.12
3261889-26188990.58591.30
4275163-27516395.17695.90
5260219-26021990.00790.69
6287942-28794299.596100.32
20min1279601-27960196.71196.252.7497.9797.472.71
2283808-28380898.16699.29
3267104-26710492.38893.61
4279343-27934396.62297.87
5271975-27197594.07395.25
6287805-28780599.549100.83
30min1280689-28068997.08795.832.5598.8897.582.50
2285912-28591298.894100.57
3276628-27662895.68397.41
4281377-28137797.32599.11
5267527-26752792.53594.24
6270113-27011393.42995.26
45min1278448-27844896.31296.921.9798.6599.211.96
2274075-27407594.80097.02
3277410-27741095.95398.22
4279295-27929596.60598.93
5281854-28185497.49099.71
6290178-290178100.369102.72
60min1285858-28585898.87597.691.39101.75100.521.40
2276801-27680195.74298.49
3279670-27967096.73599.53
4281237-28123797.277100.14
5283894-28389498.196100.96
6287103-28710399.306102.22
极限1298802-298802103.352103.060.84106.77106.430.78
2298027-298027103.084106.36
3302128-302128104.503107.84
4296573-296573102.581105.99
5297582-297582102.930106.24
6294682-294682101.927105.39
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(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777044870468704287053170206704160.18
214.777054170676706080.14
单位质量响应值RSD%判断
4767.504780.500.20数据可信
中间条件12月-供试品溶液-2024010621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%
5min155232-5523275.00973.603.1575.0173.603.15
253160-5316072.19572.19
356073-5607376.15176.15
455483-5548375.35075.35
553631-5363172.83572.83
651573-5157370.04070.04
10min166770-6677090.67892.103.4191.0992.513.39
268938-6893893.62394.02
369629-6962994.56194.98
463571-6357186.33486.75
568700-6870093.29993.70
669295-6929594.10794.50
15min169799-6979994.79295.782.3895.7196.702.37
270635-7063595.92796.85
371858-7185897.58898.54
467752-6775292.01292.91
570584-7058495.85896.78
672531-7253198.50299.41
20min169500-6950094.38697.133.2395.8398.583.21
273813-73813100.243101.70
373070-7307099.234100.72
467879-6787992.18493.59
572580-7258098.569100.02
672263-7226398.13899.60
30min171168-7116896.65196.813.7398.6298.803.69
274420-74420101.067103.08
374486-74486101.157103.20
468563-6856393.11395.03
570479-7047995.71597.72
668610-6861093.17795.18
45min171354-7135496.90497.234.5399.4199.764.45
271743-7174397.432100.00
372766-7276698.821101.43
465545-6554589.01591.45
573084-7308499.253101.79
675085-75085101.971104.49
60min173762-73762100.17498.273.22103.22101.343.17
272020-7202097.808100.92
372874-7287498.968102.12
467973-6797392.31295.25
572924-7292499.036102.12
674624-74624101.345104.43
极限174715-74715101.46898.932.14105.07102.542.06
271955-7195597.720101.38
373221-7322199.439103.14
472615-7261598.616102.06
570416-7041695.63099.27
674151-74151100.702104.35
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%
110.952844462852052849922851582851432849890.12
211.022847602847992847800.01
单位质量响应值RSD%判断
26026.3925842.110.51数据可信
中间条件12月-供试品溶液-2024010721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%
5min1100878-10087834.90339.9221.5934.9039.9221.60
278074-7807427.01327.01
3142666-14266649.36249.36
4121481-12148142.03242.03
5141117-14111748.82648.83
6107975-10797537.35937.36
10min1239583-23958382.89484.267.7883.0984.497.80
2227838-22783878.83178.98
3264083-26408391.37191.65
4224678-22467877.73777.97
5269695-26969593.31393.58
6235384-23538481.44281.65
15min1277390-27739095.97592.656.1796.6393.346.19
2257088-25708888.95189.54
3279537-27953796.71897.50
4245895-24589585.07885.74
5288824-28882499.932100.72
6257985-25798589.26189.92
20min1281145-28114597.27593.985.7498.4695.195.76
2262195-26219590.71891.80
3279430-27943096.68198.00
4250317-25031786.60887.75
5292998-292998101.376102.72
6263672-26367291.22992.39
30min1283144-28314497.96694.324.2599.6996.044.29
2257874-25787489.22390.81
3280844-28084497.17199.03
4259693-25969389.85291.47
5282897-28289797.88199.79
6271163-27116393.82195.48
45min1286882-28688299.26096.924.02101.5399.174.05
2259645-25964589.83691.92
3287395-28739599.437101.83
4275128-27512895.19397.31
5289227-289227100.071102.52
6282433-28243397.72099.90
60min1287911-28791199.61697.231.98102.44100.022.04
2277234-27723495.92298.50
3282885-28288597.877100.83
4272033-27203394.12296.77
5283333-28333398.032101.04
6282698-28269897.812100.54
极限1298775-298775103.375102.632.05106.75105.962.13
2291095-291095100.717103.83
3297675-297675102.994106.49
4288462-28846299.806102.98
5305411-305411105.671109.22
6298395-298395103.243106.51
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(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777061570613704587074770409705680.20
214.777056470533705480.04
单位质量响应值RSD%判断
4777.794776.440.02数据可信
中间条件12月-供试品溶液-2024010721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%
5min150190-5019068.11768.9321.1468.1268.9421.14
229676-2967640.27640.28
356213-5621376.29176.29
453738-5373872.93272.93
558635-5863579.57879.58
656304-5630476.41576.41
10min166394-6639490.10987.0310.8590.4987.4110.90
250421-5042168.43068.65
366979-6697990.90391.33
464208-6420887.14287.55
569930-6993094.90895.35
666809-6680990.67291.10
15min170330-7033095.45190.727.6296.3391.597.69
257217-5721777.65478.26
367955-6795592.22793.16
466141-6614189.76590.65
571541-7154197.09498.06
667893-6789392.14393.07
20min170612-7061295.83392.195.5897.2493.565.67
260924-6092482.68583.72
368604-6860493.10894.55
467058-6705891.01092.40
571597-7159797.17098.68
668755-6875593.31394.75
30min169287-6928794.03592.924.9995.9894.805.10
261584-6158483.58185.08
369911-6991194.88296.84
469125-6912593.81595.71
570578-7057895.78797.84
670286-7028695.39197.35
45min172106-7210697.86196.724.79100.3399.124.89
264352-6435287.33789.30
372976-7297699.042101.53
472721-7272198.696101.11
572337-7233798.174100.76
673118-7311899.234101.72
60min171942-7194297.63896.571.88100.6599.501.99
269221-6922193.94596.39
372307-7230798.134101.17
470955-7095596.29999.26
569995-6999594.99698.12
672504-7250498.401101.44
极限172271-7227198.08598.601.34101.64102.071.45
271836-7183697.494100.46
373798-73798100.157103.74
471346-7134696.829100.33
573276-7327699.449103.10
673367-7336799.572103.16
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%
110.952848952849672852642849512853152850780.07
211.022852572852652852610.01
单位质量响应值RSD%判断
26034.5225885.750.41数据可信
中间条件12月-供试品溶液-2024010921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%
5min1111169-11116938.42556.1624.8338.4356.1624.83
2146357-14635750.58850.59
3189908-18990865.64165.64
4196667-19666767.97867.98
5206044-20604471.21971.22
6124751-12475143.12043.12
10min1245875-24587584.98691.496.3685.2091.806.41
2274164-27416494.76495.05
3270785-27078593.59693.96
4278506-27850696.26596.64
5277988-27798896.08696.48
6240888-24088883.26283.50
15min1270097-27009793.35995.993.5194.0496.813.56
2289177-28917799.953100.76
3280713-28071397.02897.91
4276618-27661895.61396.52
5286204-28620498.92699.86
6263500-26350091.07891.78
20min1281567-28156797.32398.242.8598.5399.592.87
2297800-297800102.934104.30
3283359-28335997.94399.37
4285831-28583198.797100.24
5283986-28398698.15999.64
6272741-27274194.27295.48
30min1277703-27770395.98899.152.5797.73101.052.60
2298281-298281103.100105.03
3285128-28512898.554100.52
4292009-292009100.932102.92
5286259-28625998.945100.97
6281717-28171797.37599.11
45min1279335-27933596.55298.641.9098.83101.091.98
2288399-28839999.685102.19
3282621-28262197.687100.20
4289326-289326100.005102.56
5292451-292451101.085103.66
6280089-28008996.81299.09
60min1283669-28366998.05097.882.14100.86100.872.00
2289766-289766100.157103.22
3281937-28193797.451100.51
4275263-27526395.14498.25
5278130-27813096.13599.27
6290236-290236100.320103.13
极限1292897-292897101.239101.401.49104.60104.941.36
2292942-292942101.255104.87
3293588-293588101.478105.08
4287005-28700599.203102.84
5293002-293002101.276104.95
6300728-300728103.946107.31
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(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777059370554705367047870619705560.08
214.777077170527706490.25
单位质量响应值RSD%判断
4776.984783.280.10数据可信
中间条件12月-供试品溶液-2024010921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%
5min159418-5941880.59076.6811.8480.5976.6811.85
243804-4380459.41359.41
360528-6052882.09682.10
459658-5965880.91680.92
561383-6138383.25583.26
654434-5443473.83073.83
10min169305-6930594.00086.768.3194.4587.198.32
255140-5514074.78875.12
366302-6630289.92790.38
467280-6728091.25491.70
565728-6572889.14989.61
660057-6005781.45781.87
15min169636-6963694.44988.186.2595.4289.086.28
258629-5862979.52080.27
367024-6702490.90691.86
465586-6558688.95689.91
567392-6739291.40692.36
661807-6180783.83084.69
20min171780-7178097.35790.276.1398.8591.666.16
260506-6050682.06683.25
368024-6802492.26393.72
468258-6825892.58094.03
567764-6776491.91093.38
662978-6297885.41986.75
30min170196-7019695.20992.683.5097.2494.583.58
264129-6412986.98088.62
369096-6909693.71795.69
470174-7017495.17997.14
569481-6948194.23996.22
666913-6691390.75692.56
45min169957-6995794.88593.193.0897.4595.603.15
265892-6589289.37191.50
368384-6838492.75195.24
470013-7001394.96097.45
571321-7132196.73599.23
666678-6667890.43792.74
60min171949-7194997.58692.163.62100.6895.093.55
267221-6722191.17493.80
368985-6898593.56696.58
466572-6657290.29393.31
564703-6470387.75890.80
668256-6825692.57795.39
极限171508-7150896.98894.622.10100.6298.062.01
269825-6982594.70597.83
369031-6903193.62997.16
467876-6787692.06295.58
568893-6889393.44196.97
671440-7144096.896100.22
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