阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.11 4840648407484194842648450484220.04
212.184829948303483010.01
单位质量响应值RSD%判断
3998.513965.600.59数据可信
供试品溶液-24042901批-左氨氯地平-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%
5min141896-4189685.03079.2510.6385.0379.2510.63
242061-4206185.36585.37
333262-3326267.50767.51
434409-3440969.83569.83
540014-4001481.21181.21
642645-4264586.55086.55
10min148539-4853998.51397.082.5598.9897.522.57
248822-4882299.08799.56
347124-4712495.64196.02
447154-4715495.70296.09
546114-4611493.59194.04
649246-4924699.947100.43
15min148395-4839598.22097.392.4999.2498.372.50
248558-4855898.55199.58
348049-4804997.51898.42
447570-4757096.54697.47
545898-4589893.15294.12
649437-49437100.335101.37
20min148328-4832898.08498.242.6599.6599.762.66
249073-4907399.596101.17
348147-4814797.71799.17
448059-4805997.53898.99
546458-4645894.28995.78
650351-50351102.190103.78
30min146243-4624393.85395.723.7795.9697.793.70
245005-4500591.34093.47
346773-4677394.92896.92
448351-4835198.131100.13
546564-4656494.50496.52
650049-50049101.577103.74
45min147552-4755296.50996.783.7599.1499.383.71
248699-4869998.837101.47
345516-4551692.37794.90
448465-4846598.362100.91
545769-4576992.89195.43
650109-50109101.699104.42
60min147208-4720895.81196.872.7498.98100.012.71
249373-49373100.205103.39
346887-4688795.16098.19
448628-4862898.693101.78
545852-4585293.05996.11
648438-4843898.308101.60
极限148004-4800497.42796.952.72101.13100.622.72
248256-4825697.938101.68
347042-4704295.47499.03
447869-4786997.153100.79
545777-4577792.90796.48
649668-49668100.804104.64
阿齐沙坦左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(%)99.7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%
111.373978743976453973603975383978193976470.06
211.383970063965583967820.08
单位质量响应值RSD%判断
34973.3534866.610.22数据可信
供试品溶液-24042901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%
5min141542-4154210.6757.4432.2410.677.4432.21
231310-313108.0458.05
314042-140423.6083.61
423342-233425.9986.00
530680-306807.8847.88
632724-327248.4098.41
10min1140052-14005235.98836.0913.6736.0536.1313.68
2163231-16323141.94441.99
3110139-11013928.30128.32
4128360-12836032.98333.02
5145001-14500137.25937.30
6155855-15585540.04840.10
15min1228214-22821458.64262.955.7158.9063.195.71
2257898-25789866.26966.55
3242004-24200462.18562.36
4234166-23416660.17160.39
5242642-24264262.34962.60
6264918-26491868.07368.34
20min1274279-27427970.47975.856.0571.0676.446.02
2303643-30364378.02478.67
3313950-31395080.67281.20
4274654-27465470.57571.13
5292053-29205375.04675.64
6312456-31245680.28980.94
30min1310254-31025479.72384.305.2780.7085.315.25
2339653-33965387.27788.36
3347411-34741189.27190.24
4304235-30423578.17679.12
5328684-32868484.45885.47
6338048-33804886.86587.96
45min1330070-33007084.81589.283.8086.2390.763.79
2354215-35421591.01992.58
3364951-36495193.77895.24
4334912-33491286.05987.44
5345807-34580788.85890.34
6354788-35478891.16692.74
60min1331397-33139785.15691.434.2287.0593.414.13
2360255-36025592.57194.64
3364757-36475793.72895.72
4375562-37556296.50498.36
5350056-35005689.95091.93
6352959-35295990.69692.78
极限1389434-389434100.069100.831.77102.43103.321.75
2399306-399306102.605105.19
3390845-390845100.431102.94
4386403-38640399.290101.68
5402485-402485103.422105.90
6385906-38590699.162101.75
阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.11 4844748519484834833948395484370.15
212.184816348118481400.07
单位质量响应值RSD%判断
3999.753952.380.85数据可信
供试品溶液-24042902批-左氨氯地平-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%
5min133526-3352668.14764.5038.9368.1564.5038.94
242017-4201785.40685.41
343169-4316987.74787.75
49456-945619.22119.22
527491-2749155.88055.88
634735-3473570.60470.60
10min144693-4469390.84591.537.9591.2291.898.06
247559-4755996.67197.15
347744-4774497.04797.53
438232-3823277.71277.82
544966-4496691.40091.71
646992-4699295.51895.91
15min146135-4613593.77695.833.8894.6696.704.02
248408-4840898.39699.41
348518-4851898.62099.65
444178-4417889.79890.34
546702-4670294.92995.75
648942-4894299.482100.40
20min145299-4529992.07795.583.7893.4896.983.90
248174-4817497.92199.48
348837-4883799.268100.84
444381-4438190.21191.25
547430-4743096.40997.75
648021-4802197.61099.09
30min147088-4708895.71396.772.3197.6398.702.45
247885-4788597.33399.44
348170-4817097.913100.04
445818-4581893.13294.67
547629-4762996.81398.69
649070-4907099.742101.76
45min146772-4677295.07196.832.0497.5299.302.11
248959-4895999.516102.16
346942-4694295.41798.09
446921-4692195.37497.43
547506-4750696.56398.98
648732-4873299.055101.63
60min147062-4706295.66197.092.4298.64100.102.54
247584-4758496.72299.92
349272-49272100.153103.35
446180-4618093.86896.45
547596-4759696.74699.70
648911-4891199.419102.54
极限146156-4615693.81996.281.5297.3399.831.61
247700-4770096.957100.69
347994-4799497.555101.31
446997-4699795.52898.64
547321-4732196.18799.68
648043-4804397.655101.33
阿齐沙坦左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(%)99.7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%
111.373986183983143980223980843974923981060.11
211.383956733951473954100.10
单位质量响应值RSD%判断
35013.7234746.050.55数据可信
供试品溶液-24042902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%
5min118724-187244.8176.2747.464.826.2747.48
234193-341938.7968.80
329129-291297.4947.49
414312-143123.6823.68
510540-105402.7122.71
639404-3940410.13710.14
10min1107325-10732527.61031.8127.0427.6431.8427.05
2169186-16918643.52443.57
3151326-15132638.93038.97
4115537-11553729.72329.74
574501-7450119.16619.18
6124019-12401931.90531.96
15min1222887-22288757.33956.8018.1357.5257.0118.16
2269013-26901369.20669.50
3244495-24449562.89863.16
4223573-22357357.51657.70
5149548-14954838.47238.59
6215264-21526455.37855.61
20min1272024-27202469.98070.7910.7270.4871.3110.80
2310619-31061979.90980.58
3287316-28731673.91474.52
4271820-27182069.92870.43
5222412-22241257.21757.55
6286773-28677373.77574.32
30min1322045-32204582.84983.675.5783.7484.595.64
2338755-33875587.14788.27
3323434-32343483.20684.22
4312090-31209080.28881.18
5302389-30238977.79278.45
6352616-35261690.71391.66
45min1377281-37728197.05993.433.2698.4194.813.26
2365060-36506093.91595.52
3349503-34950389.91291.39
4354894-35489491.29992.64
5355570-35557091.47392.56
6376674-37667496.90298.36
60min1397667-397667102.30397.083.44104.1998.983.33
2363361-36336193.47895.60
3364200-36420093.69395.67
4379667-37966797.67299.52
5375070-37507096.49098.08
6384249-38424998.851100.84
极限1396320-396320101.95799.032.30104.41101.482.21
2381510-38151098.147100.79
3369783-36978395.13097.63
4388119-38811999.847102.24
5386751-38675199.495101.62
6387286-38728699.632102.18
阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.11 4831048314482674823048346482930.10
212.184825648245482500.02
单位质量响应值RSD%判断
3987.863961.410.48数据可信
供试品溶液-24042903批-左氨氯地平-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%
5min135186-3518671.54571.2510.1471.5471.2510.14
234027-3402769.18869.19
334846-3484670.85370.85
429190-2919059.35359.35
539891-3989181.11281.11
637105-3710575.44775.45
10min143921-4392189.30689.090.8289.7089.490.83
243348-4334888.14188.53
344079-4407989.62790.02
443698-4369888.85289.18
543533-4353388.51788.97
644318-4431890.11390.53
15min144734-4473490.95991.071.3691.8591.961.34
244163-4416389.79890.67
345318-4531892.14693.04
444986-4498691.47192.29
544019-4401989.50590.45
645520-4552092.55793.48
20min145853-4585393.23492.071.9194.6393.461.87
244673-4467390.83592.21
345895-4589593.32094.72
445571-4557192.66193.99
543802-4380289.06490.50
645879-4587993.28794.72
30min145827-4582793.18192.642.0195.1094.551.98
244185-4418589.84391.72
346413-4641394.37396.29
446040-4604093.61595.46
544665-4466590.81992.75
646247-4624794.03595.99
45min144162-4416289.79692.472.2592.2394.892.20
245203-4520391.91394.29
346253-4625394.04896.49
446421-4642194.38996.76
544427-4442790.33592.77
646390-4639094.32696.80
60min145202-4520291.91192.131.8394.8495.061.80
244394-4439490.26893.15
346236-4623694.01396.98
445934-4593493.39996.29
544272-4427290.02092.96
645810-4581093.14796.15
极限145347-4534792.20593.102.7195.6596.542.63
244438-4443890.35793.75
346655-4665594.86598.36
447513-4751396.610100.02
544490-4449090.46393.90
646268-4626894.07897.59
阿齐沙坦左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(%)99.7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%
111.373970773972983972603965733970213970460.08
211.383960493966793963640.12
单位质量响应值RSD%判断
34920.4934829.880.19数据可信
供试品溶液-24042903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%
5min133036-330368.50014.1537.868.5014.1537.85
284671-8467121.78521.78
331659-316598.1468.15
452418-5241813.48713.49
557462-5746214.78414.78
670733-7073318.19918.20
10min1231311-23131159.51458.0610.2259.5658.1410.22
2261991-26199167.40867.53
3230663-23066359.34759.39
4211105-21110554.31554.39
5193010-19301049.65949.74
6225902-22590258.12258.22
15min1319727-31972782.26280.595.5882.6481.005.59
2325092-32509283.64384.14
3325011-32501183.62284.00
4284172-28417273.11473.49
5299339-29933977.01777.37
6326115-32611583.90684.33
20min1360689-36068992.80189.364.7693.6490.214.73
2346670-34667089.19590.15
3345963-34596389.01389.85
4316009-31600981.30682.09
5357644-35764492.01892.80
6356982-35698291.84892.74
30min1386969-38696999.56395.215.09100.9196.565.05
2364599-36459993.80795.26
3361488-36148893.00794.34
4339553-33955387.36388.60
5389771-389771100.284101.58
6378023-37802397.26198.66
45min1397818-397818102.35498.244.01104.26100.113.99
2383108-38310898.570100.55
3368576-36857694.83196.68
4360531-36053192.76194.48
5398653-398653102.569104.42
6382211-38221198.339100.28
60min1394278-394278101.44498.223.36103.92100.643.32
2374747-37474796.41898.94
3371917-37191795.69098.07
4369419-36941995.04897.28
5400727-400727103.103105.53
6379523-37952397.647100.13
极限1393746-393746101.307100.052.61104.34103.022.50
2374526-37452696.36299.42
3381795-38179598.232101.14
4396743-396743102.078104.84
5401370-401370103.268106.27
6385032-38503299.065102.09
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