氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566478764810648426479164683647830.10
212.556499965028650140.04
单位质量响应值RSD%判断
5157.885180.400.31数据可信
供试品溶液-2025020311批-氨氯地平-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140767-4076751.13258.459.6851.1358.459.68
245161-4516156.64456.64
354268-5426868.06668.07
448236-4823660.50060.50
544581-4458155.91655.92
646589-4658958.43558.43
10min174288-7428893.17697.073.4893.7497.723.51
278513-7851398.47699.11
380800-80800101.344102.10
478988-7898899.07199.74
574072-7407292.90593.53
677688-7768897.44198.09
15min179297-7929799.459101.321.20101.06103.051.22
281122-81122101.748103.47
381627-81627102.381104.26
480122-80122100.494102.27
581858-81858102.671104.32
680661-80661101.170102.90
20min179499-7949999.712100.431.31102.42103.281.32
280986-80986101.577104.43
381305-81305101.978105.00
478591-7859198.573101.46
580563-80563101.047103.84
679475-7947599.682102.54
30min179193-7919399.329100.691.16103.14104.661.17
281100-81100101.720105.70
380732-80732101.259105.41
480402-80402100.845104.83
581169-81169101.807105.72
679074-7907499.179103.14
45min179108-7910899.222100.351.11104.14105.441.14
280298-80298100.714105.83
381356-81356102.041107.32
478990-7899099.074104.18
580369-80369100.804105.85
679931-79931100.254105.32
60min178641-7864198.636100.491.46104.66106.691.49
280213-80213100.608106.84
382215-82215103.119109.53
479755-79755100.033106.24
579784-79784100.070106.24
680104-80104100.471106.65
极限177741-7774197.50798.821.05104.63106.141.08
278817-7881798.857106.21
379923-79923100.244107.80
477999-7799997.831105.15
579385-7938599.569106.85
678861-7886198.912106.21
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011336128133674813376141336537133701013368070.05
29.051332868133473913338040.10
单位质量响应值RSD%判断
148369.26147381.660.48数据可信
供试品溶液-2025020311批-厄贝沙坦-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1536122-53612232.63036.899.3732.6336.899.36
2589431-58943135.87435.87
3692430-69243042.14342.14
4636619-63661938.74638.75
5558769-55876934.00834.01
6623416-62341637.94337.94
10min11304704-130470479.40881.684.4479.7782.094.45
21359855-135985582.76483.16
31381357-138135784.07384.54
41408777-140877785.74286.17
51242799-124279975.64076.02
61354823-135482382.45882.88
15min11547524-154752494.18695.370.8095.4396.680.83
21586566-158656696.56397.88
31569389-156938995.51796.92
41567300-156730095.39096.77
51563511-156351195.16096.38
61567117-156711795.37996.72
20min11605281-160528197.70298.071.0199.99100.440.98
21638460-163846099.721102.11
31614359-161435998.254100.72
41589319-158931996.73099.17
51614470-161447098.261100.54
61605766-160576697.731100.13
30min11635608-163560899.54899.481.19102.92102.941.12
21659647-1659647101.011104.51
31617723-161772398.459102.01
41630334-163033499.227102.74
51653653-1653653100.646104.01
61610200-161020098.001101.48
45min11636304-163630499.59099.810.76104.07104.380.70
21647800-1647800100.290104.91
31641303-164130399.894104.54
41622842-162284298.771103.39
51658465-1658465100.939105.42
61632862-163286299.380103.95
60min11627090-162709099.02999.800.57104.62105.480.57
21638923-163892399.749105.49
31653570-1653570100.641106.40
41633350-163335099.410105.13
51646043-1646043100.183105.79
61639727-163972799.798105.47
极限11617372-161737298.43898.730.53105.13105.520.50
21623092-162309298.786105.63
31628557-162855799.118106.00
41607779-160777997.854104.68
51631494-163149499.297106.02
61624492-162449298.871105.66
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566474964895642646432964477645430.43
212.556534965450654000.11
单位质量响应值RSD%判断
5138.775211.160.99数据可信
供试品溶液-2025020411批-氨氯地平-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140586-4058650.85050.773.0650.8550.773.06
241176-4117651.59051.59
340269-4026950.45350.45
438433-3843348.15348.15
542200-4220052.87252.87
640462-4046250.69550.69
10min172111-7211190.34888.752.1390.9189.322.11
271055-7105589.02589.60
369930-6993087.61588.18
471816-7181689.97890.51
571879-7187990.05790.64
668228-6822885.48386.05
15min175572-7557294.68493.562.6196.2595.122.58
273963-7396392.66894.23
374078-7407892.81394.35
476977-7697796.44597.98
575994-7599495.21396.80
671484-7148489.56291.08
20min174032-7403292.75592.852.0295.3895.442.01
274342-7434293.14395.74
373051-7305191.52694.09
476006-7600695.22897.83
575333-7533394.38597.03
671893-7189390.07592.58
30min173043-7304391.51691.812.8395.1795.442.79
272682-7268291.06394.69
373732-7373292.37995.96
475493-7549394.58598.25
575036-7503694.01397.71
669694-6969487.32090.83
45min173106-7310691.59591.342.9496.2695.982.89
271872-7187290.04994.69
372840-7284091.26195.87
475165-7516594.17498.89
575029-7502994.00498.74
669427-6942786.98591.46
60min171494-7149489.57590.082.3095.2695.732.29
271313-7131389.34894.99
371371-7137189.42195.04
473874-7387492.55798.32
573758-7375892.41298.20
669555-6955587.14692.59
极限171651-7165189.77288.562.8796.4595.222.81
270721-7072188.60795.24
370654-7065488.52395.14
472669-7266991.04797.84
571598-7159889.70596.52
666832-6683283.73490.15
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011332391133249213316291329389133156513314930.10
29.051347010134686113469360.01
单位质量响应值RSD%判断
147779.47148832.710.51数据可信
供试品溶液-2025020411批-厄贝沙坦-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1501708-50170830.44730.876.7230.4530.876.71
2500701-50070130.38630.39
3496120-49612030.10830.11
4467863-46786328.39328.39
5570721-57072134.63534.63
6515279-51527931.27031.27
10min11237237-123723775.08374.800.3375.4275.140.35
21229135-122913574.59174.93
31226965-122696574.46074.79
41231206-123120674.71775.03
51235528-123552874.97975.36
61235148-123514874.95675.30
15min11517954-151795492.11992.160.6893.2993.330.67
21511000-151100091.69792.86
31521486-152148692.33393.49
41535664-153566493.19394.34
51520071-152007192.24793.47
61505506-150550691.36392.54
20min11566772-156677295.08195.170.6097.2897.370.60
21582473-158247396.03498.22
31560845-156084594.72296.91
41558374-155837494.57296.75
51576566-157656695.67697.92
61564725-156472594.95797.15
30min11570558-157055895.31196.460.9898.5699.710.95
21587965-158796596.36799.62
31610551-161055197.738100.98
41602125-160212597.227100.46
51591445-159144596.57999.88
61574224-157422495.53398.78
45min11581754-158175495.99096.630.92100.30100.950.90
21582155-158215596.015100.34
31604739-160473997.385101.71
41599371-159937197.060101.37
51610663-161066397.745102.12
61574875-157487595.57399.88
60min11556945-155694594.48595.420.6099.86100.820.59
21567899-156789995.150100.54
31577044-157704495.705101.11
41570769-157076995.324100.71
51584015-158401596.128101.59
61577289-157728995.719101.09
极限11551756-155175694.17094.301.16100.60100.761.09
21560999-156099994.731101.18
31569996-156999695.277101.75
41569938-156993895.273101.72
51548721-154872193.986100.52
61522225-152222592.37898.82
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566480865151652566490865197650640.30
212.556402264390642060.41
单位质量响应值RSD%判断
5180.255116.020.89数据可信
供试品溶液-2025020511批-氨氯地平-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145413-4541357.19458.022.9257.1958.022.92
246146-4614658.11758.12
344018-4401855.43755.44
447421-4742159.72359.72
547631-4763159.98759.99
645776-4577657.65157.65
10min171451-7145189.98792.421.9290.6293.061.90
272786-7278691.66892.31
374920-7492094.35694.97
472276-7227691.02691.69
574315-7431593.59494.26
674544-7454493.88294.52
15min173902-7390293.07494.181.3594.7195.851.34
275029-7502994.49396.16
375661-7566195.28996.95
473182-7318292.16793.84
575577-7557795.18396.89
675314-7531494.85296.54
20min173800-7380092.94592.731.2395.6195.441.21
272503-7250391.31294.03
374252-7425293.51496.24
472816-7281691.70694.40
574930-7493094.36897.13
673453-7345392.50895.25
30min173768-7376892.90591.781.9896.6195.521.87
273064-7306492.01895.75
371407-7140789.93193.69
475189-7518994.69498.41
572132-7213290.84494.66
671669-7166990.26194.03
45min172182-7218290.90790.670.8295.6495.440.76
272416-7241691.20295.95
371428-7142889.95894.72
472860-7286091.76196.53
571555-7155590.11894.94
671518-7151890.07194.84
60min172487-7248791.29290.921.1397.0496.701.07
272129-7212990.84196.61
370713-7071389.05794.82
472944-7294491.86797.66
572042-7204290.73196.55
672857-7285791.75897.53
极限172580-7258091.40990.571.7698.1797.361.64
272800-7280091.68698.46
370789-7078989.15395.90
473507-7350792.57699.39
570230-7023088.44995.28
671591-7159190.16396.95
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011341302134806613462551343308134803213453930.23
29.051325569133374513296570.44
单位质量响应值RSD%判断
149322.20146923.431.15数据可信
供试品溶液-2025020511批-厄贝沙坦-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1648361-64836139.39739.206.1739.4039.206.16
2673622-67362240.93240.93
3586123-58612335.61535.62
4681293-68129341.39841.40
5674079-67407940.96040.96
6607080-60708036.88936.89
10min11319680-131968080.19081.971.4880.6382.401.49
21376253-137625383.62784.08
31343352-134335281.62882.02
41359936-135993682.63683.10
51357638-135763882.49682.95
61337045-133704581.24581.65
15min11494068-149406890.78691.430.7692.1192.780.77
21510826-151082691.80493.19
31502029-150202991.27092.57
41494970-149497090.84192.22
51524395-152439592.62994.00
61501992-150199291.26892.58
20min11518474-151847492.26992.260.9294.6194.620.91
21511609-151160991.85294.26
31517094-151709492.18594.50
41503546-150354691.36293.75
51544620-154462093.85896.26
61514355-151435592.01994.35
30min11536091-153609193.34092.541.1996.7095.921.18
21534954-153495493.27196.70
31510066-151006691.75895.10
41542221-154222193.71297.11
51518680-151868092.28295.73
61495214-149521490.85694.20
45min11533357-153335793.17392.070.9397.5796.480.91
21529889-152988992.96397.42
31507868-150786891.62595.99
41508614-150861491.67096.11
51514809-151480992.04696.52
61496647-149664790.94395.30
60min11531658-153165893.07092.350.7398.5197.790.73
21520144-152014492.37197.86
31502111-150211191.27596.65
41523150-152315092.55398.02
51529169-152916992.91998.41
61512787-151278791.92497.29
极限11524496-152449692.63592.500.9399.1098.970.90
21542788-154278893.747100.27
31500630-150063091.18597.58
41527917-152791792.84399.33
51514528-151452892.02998.55
61523733-152373392.58998.98
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