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%
110.952838842843292838372837922836732839030.09
211.022843862843712843780.01
单位质量响应值RSD%判断
25927.2125805.630.34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%
5min167511-6751123.42024.0026.3623.4224.0026.35
286987-8698730.17630.18
348747-4874716.91016.91
473191-7319125.39025.39
548018-4801816.65716.66
690633-9063331.44131.44
10min1233766-23376681.09377.639.2881.2277.769.30
2246273-24627385.43285.60
3192524-19252466.78666.88
4226790-22679078.67378.81
5205059-20505971.13571.23
6238265-23826582.65482.83
15min1269562-26956293.51190.234.4494.0990.804.48
2271904-27190494.32394.97
3254858-25485888.41088.88
4260997-26099790.54091.12
5240130-24013083.30183.79
6263241-26324191.31891.95
20min1282475-28247597.99094.602.4499.0995.672.45
2277100-27710096.12697.29
3274557-27455795.24496.20
4268939-26893993.29594.38
5264070-26407091.60692.56
6269077-26907793.34394.48
30min1276862-27686296.04396.151.9297.6997.741.85
2274839-27483995.34297.04
3281031-28103197.49098.97
4284796-28479698.796100.40
5276145-27614595.79597.25
6269326-26932693.42995.09
45min1282006-28200697.82896.742.00100.0198.861.99
2281830-28183097.767100.00
3284911-28491198.835100.86
4279418-27941896.93099.08
5269517-26951793.49595.49
6275490-27549095.56797.75
60min1286619-28661999.42897.171.48102.1599.831.47
2281007-28100797.481100.25
3281709-28170997.725100.30
4279559-27955996.97999.67
5277189-27718996.15798.67
6274526-27452695.23397.94
极限1282138-28213897.874101.571.99101.15104.771.89
2295139-295139102.384105.70
3294542-294542102.176105.30
4297680-297680103.265106.49
5296938-296938103.008106.05
6290299-290299100.705103.94
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%
114.777003470534701647022169994701890.31
214.777051870318704180.21
单位质量响应值RSD%判断
4752.134767.640.24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%
5min148769-4876966.42862.4713.7266.4362.4713.71
254316-5431673.98473.98
341484-4148456.50556.51
441133-4113356.02756.03
538669-3866952.67152.67
650812-5081269.21169.21
10min164439-6443987.77285.595.1088.1485.945.13
267095-6709591.39091.80
363592-6359286.61986.93
460370-6037082.23082.54
557989-5798978.98779.28
663537-6353786.54486.93
15min167195-6719591.52688.974.9492.3889.804.96
268874-6887493.81394.73
365817-6581789.64990.44
463966-6396687.12887.90
559624-5962481.21481.95
666455-6645590.51891.38
20min170284-7028495.73492.353.4097.1093.673.44
270026-7002695.38296.82
368373-6837393.13194.42
465811-6581189.64190.89
564479-6447987.82789.01
667830-6783092.39193.76
30min168314-6831493.05093.182.0794.9595.012.09
268965-6896593.93795.91
368616-6861693.46295.27
470096-7009695.47897.23
565814-6581489.64591.32
668629-6862993.47995.36
45min171544-7154497.45095.133.4999.8697.483.51
272157-7215798.285100.78
370443-7044395.95098.28
469865-6986595.16397.44
565267-6526788.90091.07
669762-6976295.02397.42
60min172810-7281099.17494.803.42102.1397.683.44
271397-7139797.250100.29
369331-6933194.43697.30
468888-6888893.83296.64
565862-6586289.71092.37
669320-6932094.42197.35
极限170176-7017695.58795.142.7999.0998.552.81
272854-7285499.234102.81
370159-7015995.56398.95
470171-7017195.58098.91
566938-6693891.17694.34
668811-6881193.72797.18
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%
110.952842992844642845052843642843182843900.04
211.022847402842572844980.13
单位质量响应值RSD%判断
25971.6925816.520.43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%
5min1155528-15552853.89548.2911.8853.9048.2911.88
2130666-13066645.28045.28
3151430-15143052.47552.48
4154651-15465153.59153.59
5117185-11718540.60840.61
6126643-12664343.88643.89
10min1276122-27612295.68587.198.7595.9887.468.76
2236395-23639581.91882.17
3255912-25591288.68188.97
4274118-27411894.99095.29
5219177-21917775.95176.18
6247988-24798885.93586.18
15min1288895-288895100.11194.616.90100.9495.366.92
2258903-25890389.71890.42
3282146-28214697.77298.56
4290007-290007100.496101.32
5242329-24232983.97484.62
6275811-27581195.57796.30
20min1288889-288889100.10996.475.39101.5097.755.43
2267971-26797192.86094.07
3283522-28352298.24999.58
4293362-293362101.659103.04
5253252-25325287.75988.87
6283332-28333298.18399.44
30min1290823-290823100.77996.814.80102.7298.624.84
2267114-26711492.56394.28
3283674-28367498.302100.17
4291581-291581101.042102.99
5258804-25880489.68391.28
6284216-28421698.489100.29
45min1288808-288808100.08197.803.91102.58100.153.96
2273501-27350194.77697.01
3294761-294761102.143104.56
4288653-288653100.027102.54
5265233-26523391.91194.01
6282372-28237297.850100.20
60min1290367-290367100.62198.554.01103.68101.454.05
2276483-27648395.81098.57
3289407-289407100.288103.27
4301740-301740104.562107.63
5271371-27137194.03896.65
6277045-27704596.00498.89
极限1295198-295198102.295103.771.46105.91107.221.46
2294330-294330101.994105.29
3304954-304954105.676109.22
4299889-299889103.921107.57
5298539-298539103.453106.59
6303860-303860105.297108.72
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%
114.777037270321704027029370383703540.07
214.776995669873699140.09
单位质量响应值RSD%判断
4763.304733.510.45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%
5min155726-5572676.08877.747.0576.0977.747.05
251413-5141370.19970.20
362883-6288385.86085.86
459037-5903780.60980.61
558231-5823179.50979.51
654304-5430474.14774.15
10min167702-6770292.44093.462.5392.8693.892.54
265614-6561489.58989.98
370744-7074496.59497.07
469426-6942694.79495.24
568465-6846593.48293.92
668748-6874893.86894.28
15min169934-6993495.48896.132.3196.4297.082.33
267626-6762692.33693.22
372536-7253699.041100.05
471157-7115797.15898.13
570665-7066596.48697.45
670528-7052896.29997.23
20min170031-7003195.62097.262.1397.0998.742.15
268880-6888094.04995.45
373024-7302499.707101.27
472120-7212098.47399.99
571853-7185398.10899.61
671467-7146797.58199.05
30min172141-7214198.50197.442.46100.5099.462.46
267808-6780892.58594.51
372069-7206998.403100.52
472391-7239198.843100.90
572024-7202498.342100.38
671727-7172797.93699.95
45min171623-7162397.79499.002.43100.34101.572.44
270198-7019895.84898.29
375521-75521103.116105.78
472506-7250699.000101.61
572978-7297899.644102.23
672213-7221398.600101.15
60min172158-7215898.52498.802.77101.61101.922.75
270092-7009295.70498.67
373488-73488100.340103.58
475502-75502103.090106.25
572491-7249198.979102.12
670435-7043596.17299.27
极限171296-7129697.34897.971.10100.98101.631.14
270456-7045696.20199.70
372555-7255599.067102.86
472108-7210898.456102.19
571700-7170097.899101.59
672384-7238498.833102.47
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%
110.952846162844602844722841152841172843560.09
211.022849712847782848740.05
单位质量响应值RSD%判断
25968.5825850.640.33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%
5min152521-5252118.18940.0629.0618.1940.0629.06
2121340-12134042.02342.02
3147880-14788051.21451.21
4110169-11016938.15438.15
5137694-13769447.68647.69
6124395-12439543.08143.08
10min1191805-19180566.42679.639.0766.5379.859.11
2229431-22943179.45779.69
3225800-22580078.19978.48
4238174-23817482.48582.70
5251519-25151987.10687.37
6242865-24286584.10984.35
15min1235187-23518781.45088.855.2581.9289.525.30
2253555-25355587.81188.49
3247981-24798185.88186.60
4266081-26608192.14992.82
5269032-26903293.17193.92
6267525-26752592.65093.36
20min1255820-25582088.59691.923.0489.5293.083.08
2269615-26961593.37394.54
3254869-25486988.26789.46
4274245-27424594.97796.16
5268078-26807892.84194.11
6269823-26982393.44594.67
30min1268824-26882493.09994.482.1694.5196.142.19
2272583-27258394.40196.08
3263274-26327491.17792.86
4276404-27640495.72597.43
5278778-27877896.54798.33
6276926-27692695.90597.65
45min1281114-28111497.35695.142.3599.2997.342.26
2274383-27438395.02597.23
3263644-26364491.30593.50
4279179-27917996.68698.93
5278399-27839996.41598.73
6271592-27159294.05896.33
60min1275636-27563695.45995.061.5697.9397.781.54
2276829-27682995.87298.61
3266182-26618292.18494.88
4276000-27600095.58598.36
5278059-27805996.29899.15
6274173-27417394.95297.75
极限1292151-292151101.178100.871.30104.18104.121.30
2289785-289785100.359103.63
3286724-28672499.299102.51
4287881-28788199.699103.01
5295083-295083102.193105.58
6295962-295962102.498105.82
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%
114.777000770360705857042770270703300.31
214.777044769984702160.47
单位质量响应值RSD%判断
4761.684753.960.12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%
5min128129-2812938.33165.3520.6138.3365.3520.61
254294-5429473.98673.99
352939-5293972.13972.14
452780-5278071.92371.92
550026-5002668.17068.17
649577-4957767.55867.56
10min161981-6198184.46186.093.0884.6786.463.10
263848-6384887.00587.42
362302-6230284.89885.30
465370-6537089.07989.48
560429-6042982.34682.72
665145-6514588.77289.15
15min167592-6759292.10790.992.0992.7991.832.04
266008-6600889.94890.84
364443-6444387.81688.69
467189-6718991.55892.45
566961-6696191.24792.08
668434-6843493.25494.12
20min168173-6817392.89893.151.5494.0994.501.54
268996-6899694.02095.41
366751-6675190.96192.32
469226-6922694.33395.74
567587-6758792.10093.44
669409-6940994.58395.97
30min167885-6788592.50694.732.3994.2296.592.39
269037-6903794.07695.99
367629-6762992.15794.02
470307-7030795.80697.73
570259-7025995.74197.60
671979-7197998.085100.00
45min171884-7188497.95596.511.63100.1898.901.58
270412-7041295.94998.39
368964-6896493.97696.35
472165-7216598.338100.80
570956-7095696.69199.08
670578-7057896.17698.63
60min170710-7071096.35696.861.5099.1299.781.51
272380-7238098.631101.60
369370-6937094.53097.43
471621-7162197.597100.60
570652-7065296.27699.20
671748-7174897.770100.76
极限172008-7200898.12496.501.91101.4399.971.85
270237-7023795.71199.23
368699-6869993.61597.04
471448-7144897.361100.91
570236-7023695.71099.17
672289-7228998.507102.04
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%
110.952845252845052840602845152845732844360.08
211.022843142842842842990.01
单位质量响应值RSD%判断
25975.8925798.460.49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%
5min1165685-16568557.43059.573.7157.4359.573.71
2163733-16373356.75456.75
3169507-16950758.75558.76
4176733-17673361.26061.26
5177569-17756961.55061.55
6177882-17788261.65861.66
10min1257415-25741589.22691.731.9289.5592.061.92
2263067-26306791.18591.50
3266355-26635592.32592.65
4263412-26341291.30591.65
5264583-26458391.71192.05
6272977-27297794.62094.96
15min1282562-28256297.94397.960.7298.7698.800.71
2284982-28498298.78199.60
3280491-28049197.22598.06
4282289-28228997.84898.70
5280432-28043297.20498.06
6284905-28490598.75599.62
20min1291460-291460101.02799.181.69102.39100.571.66
2288091-28809199.859101.23
3283199-28319998.16399.54
4286177-28617799.196100.59
5278233-27823396.44297.83
6289719-289719100.423101.84
30min1296454-296454102.758101.331.62104.68103.271.59
2297152-297152103.000104.93
3291576-291576101.067102.99
4293353-293353101.683103.63
5284004-28400498.442100.37
6291485-291485101.036103.01
45min1287870-28787099.783100.061.54102.27102.561.51
2284160-28416098.497100.99
3288057-28805799.847102.33
4296996-296996102.946105.45
5285940-28594099.114101.59
6289028-289028100.184102.72
60min1296123-296123102.643102.302.67105.69105.362.60
2301192-301192104.400107.45
3291808-291808101.148104.19
4305351-305351105.842108.92
5282760-28276098.011101.04
6293572-293572101.759104.85
极限1297735-297735103.202102.431.21106.82106.051.19
2295339-295339102.371106.00
3298362-298362103.419107.02
4298449-298449103.449107.12
5289260-289260100.264103.83
6293845-293845101.854105.51
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%
114.777014670014700936995969965700350.12
214.777014070178701590.04
单位质量响应值RSD%判断
4741.714750.100.13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%
5min158074-5807479.33576.696.6679.3476.696.66
254865-5486574.95174.95
356855-5685577.67077.67
449182-4918267.18867.19
559102-5910280.74080.74
658750-5875080.25980.26
10min164912-6491288.67786.686.3189.1287.116.31
265207-6520789.08089.50
364852-6485288.59589.03
455309-5530975.55875.93
565548-6554889.54689.99
664885-6488588.64089.09
15min167527-6752792.24989.546.8593.1890.456.85
266735-6673591.16792.08
367485-6748592.19293.12
456490-5649077.17177.96
568480-6848093.55194.50
666551-6655190.91691.85
20min168826-6882694.02490.116.1095.4791.526.11
266670-6667091.07892.50
367660-6766092.43193.87
457888-5788879.08180.30
567181-6718191.77693.24
667561-6756192.29693.74
30min170257-7025795.97993.215.2997.9595.125.31
269402-6940294.81196.73
369843-6984395.41397.36
460905-6090583.20384.86
569420-6942094.83596.81
669571-6957195.04197.00
45min167078-6707891.63692.054.1594.1494.474.18
265908-6590890.03792.49
368762-6876293.93696.42
462726-6272685.69087.81
570427-7042796.21198.71
669366-6936694.76197.25
60min170548-7054896.37694.883.2299.3997.823.27
271036-7103697.04399.99
370336-7033696.08799.09
465180-6518089.04391.64
568845-6884594.05097.09
670776-7077696.68899.70
极限169579-6957995.05294.331.7698.6097.801.76
268590-6859093.70197.19
370692-7069296.573100.11
468422-6842293.47296.57
567247-6724791.86795.43
669791-6979195.34298.89
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