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%
111.214520644686449114503445099449870.45
211.174481645119449680.48
单位质量响应值RSD%判断
4013.114025.780.23数据可信
加速1月-供试品溶液-24051501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%
5min140524-4052481.47983.522.7881.4883.522.78
240538-4053881.50781.51
341817-4181784.07984.08
442159-4215984.76784.77
540768-4076881.97081.97
643421-4342187.30487.30
10min146609-4660993.71494.531.7994.1794.991.79
245857-4585792.20292.65
348291-4829197.09697.56
447419-4741995.34395.81
547298-4729895.09995.55
646618-4661893.73294.22
15min147158-4715894.81896.151.7095.7997.141.70
246980-4698094.46095.43
349028-4902898.57899.58
448177-4817796.86797.87
548331-4833197.17698.16
647261-4726195.02596.03
20min145016-4501690.51193.962.4892.0195.482.46
245879-4587992.24693.74
348311-4831197.13698.69
446692-4669293.88195.42
547318-4731895.14096.66
647161-4716194.82496.36
30min146739-4673993.97595.993.0095.9898.032.97
245477-4547791.43893.44
349202-4920298.928101.02
448754-4875498.027100.09
548702-4870297.92299.97
647563-4756395.63297.69
45min149421-4942199.36897.981.60101.89100.561.58
247601-4760195.70998.22
349195-4919598.914101.56
449552-4955299.631102.24
548310-4831097.13499.73
648299-4829997.11299.70
60min148748-4874898.01596.922.36101.09100.042.30
247370-4737095.24498.29
349446-4944699.418102.61
446357-4635793.20796.37
548885-4888598.290101.43
648404-4840497.323100.45
极限148573-4857397.66398.011.71101.28101.671.70
247404-4740495.31398.88
349596-4959699.720103.47
448538-4853897.593101.27
549666-4966699.861103.54
648702-4870297.922101.59
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(%)99.70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%
111.513977593954163970133947423974503964760.34
211.443940763947983944370.13
单位质量响应值RSD%判断
34446.2234478.760.07数据可信
加速1月-供试品溶液-24051501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%
5min1112831-11283129.37830.448.8929.3830.448.90
2122868-12286831.99131.99
3111112-11111228.93028.93
4128169-12816933.37133.37
5100952-10095226.28526.28
6125420-12542032.65632.66
10min1273544-27354471.22372.733.1171.3972.903.12
2287411-28741174.83375.01
3286853-28685374.68874.85
4284166-28416673.98874.17
5265262-26526269.06669.21
6278669-27866972.55772.74
15min1300533-30053378.25080.482.2778.8181.052.27
2314806-31480681.96682.56
3319903-31990383.29383.87
4307566-30756680.08180.68
5306096-30609679.69880.23
6305639-30563979.57980.16
20min1307402-30740280.03881.522.2481.0382.542.24
2314710-31471081.94182.99
3326018-32601884.88585.92
4313188-31318881.54582.59
5307403-30740380.03981.01
6309808-30980880.66581.69
30min1319872-31987283.28583.771.7684.7285.241.75
2324254-32425484.42685.93
3331449-33144986.29987.81
4316665-31666582.45083.94
5321839-32183983.79785.21
6316329-31632982.36383.84
45min1359287-35928793.54889.912.7895.4591.852.72
2339962-33996288.51690.49
3343310-34331089.38891.38
4353610-35361092.06994.02
5332755-33275586.63988.52
6343058-34305889.32291.25
60min1372457-37245796.97792.033.0299.4094.472.95
2345322-34532289.91292.38
3349972-34997291.12293.61
4358149-35814993.25195.72
5343243-34324389.37091.73
6351608-35160891.54893.98
极限1389293-389293101.360101.890.60104.32104.840.61
2395618-395618103.007105.97
3392059-392059102.080105.07
4390558-390558101.690104.67
5389380-389380101.383104.24
6391007-391007101.807104.74
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%
111.214479345044448144481545264449460.46
211.174496845185450760.35
单位质量响应值RSD%判断
4009.464035.450.46数据可信
加速1月-供试品溶液-24051502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%
5min141333-4133383.04584.372.9183.0484.372.90
240257-4025780.88380.88
341612-4161283.60583.61
443483-4348387.36487.36
542019-4201984.42384.42
643259-4325986.91486.91
10min147520-4752095.47595.452.8095.9495.922.80
245972-4597292.36592.81
348869-4886998.18698.65
449255-4925598.96199.45
546319-4631993.06293.53
647099-4709994.62995.11
15min147715-4771595.86796.041.7496.8697.041.74
247383-4738395.20096.16
347820-4782096.07897.09
448934-4893498.31699.35
546540-4654093.50694.49
648413-4841397.26998.28
20min148401-4840197.24597.011.7398.7798.551.73
247446-4744695.32696.82
349139-4913998.728100.27
449136-4913698.722100.30
547155-4715594.74296.25
648438-4843897.32098.87
30min147666-4766695.76995.702.2597.8397.772.24
247131-4713194.69496.71
347935-4793596.30998.40
449557-4955799.568101.70
546480-4648093.38695.42
647027-4702794.48596.57
45min146025-4602592.47195.414.3395.0798.014.25
245644-4564491.70694.25
351068-51068102.604105.23
448727-4872797.900100.58
546539-4653993.50496.05
646915-4691594.26096.87
60min147372-4737295.17896.242.8098.2999.372.78
246899-4689994.22797.28
349391-4939199.234102.43
449698-4969899.851103.08
546435-4643593.29596.37
647596-4759695.62898.77
极限147373-4737395.18096.402.6798.82100.072.65
246533-4653393.49297.07
349641-4964199.737103.49
449028-4902898.505102.29
546754-4675493.93697.52
648558-4855897.561101.23
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(%)99.70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%
111.513955723954723945033942903941243947920.18
211.443932793934803933800.04
单位质量响应值RSD%判断
34299.9134386.360.18数据可信
加速1月-供试品溶液-24051502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%
5min1116668-11666830.48228.358.6330.4828.358.63
2105915-10591527.67327.67
396497-9649725.21225.21
4100586-10058626.28126.28
5110453-11045328.85928.86
6120901-12090131.58831.59
10min1280783-28078373.36271.614.1573.5371.774.16
2283324-28332474.02674.18
3255030-25503066.63366.77
4266021-26602169.50569.65
5276244-27624472.17672.34
6283152-28315273.98174.16
15min1304637-30463779.59479.812.3280.1780.362.33
2314066-31406682.05882.62
3297823-29782377.81478.32
4306510-30651080.08380.62
5297244-29724477.66378.22
6312444-31244481.63482.22
20min1314366-31436682.13682.883.2283.1683.883.21
2335269-33526987.59888.62
3307993-30799380.47181.41
4313992-31399282.03883.02
5309217-30921780.79181.78
6322446-32244684.24785.29
30min1319010-31901083.34984.823.6484.8286.283.61
2345016-34501690.14491.65
3317355-31735582.91784.31
4330180-33018086.26887.70
5311775-31177581.45982.90
6324447-32444784.77086.28
45min1326689-32668985.35689.516.9387.2991.446.76
2343109-34310989.64691.65
3372235-37223597.25699.11
4369795-36979596.61898.53
5315379-31537982.40184.29
6328300-32830085.77787.76
60min1345628-34562890.30492.394.1892.7294.824.08
2351841-35184191.92794.43
3365663-36566395.53997.93
4376934-37693498.484100.93
5341684-34168489.27491.63
6339856-33985688.79691.25
极限1371594-37159497.08898.751.74100.00101.691.70
2372206-37220697.248100.27
3379506-37950699.156102.08
4383947-383947100.316103.31
5373500-37350097.586100.43
6387036-387036101.123104.07
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%
111.214522344984450684523845065451160.25
211.174511945170451440.08
单位质量响应值RSD%判断
4024.624041.540.30数据可信
加速1月-供试品溶液-24051503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%
5min139499-3949979.15083.453.0779.1583.453.07
240975-4097582.10882.11
342951-4295186.06786.07
441577-4157783.31483.31
542693-4269385.55085.55
642168-4216884.49884.50
10min146258-4625892.69494.290.9593.1394.750.95
247050-4705094.28194.74
347041-4704194.26394.74
447554-4755495.29195.75
547373-4737394.92895.40
647046-4704694.27394.74
15min147219-4721994.62095.311.5095.5796.291.49
246540-4654093.25994.24
347477-4747795.13796.14
447471-4747195.12596.12
548618-4861897.42398.43
648042-4804296.26997.26
20min147234-4723494.65095.801.0596.1397.311.05
247579-4757995.34196.84
347559-4755995.30196.83
448289-4828996.76498.28
548548-4854897.28398.83
647625-4762595.43396.96
30min145753-4575391.68297.083.6993.6999.133.64
247021-4702194.22396.25
350593-50593101.381103.44
448480-4848097.14799.21
549666-4966699.523101.61
649170-4917098.529100.59
45min147771-4777195.72697.831.7798.24100.421.76
248968-4896898.125100.68
349720-4972099.632102.25
447733-4773395.65098.25
549375-4937598.940101.58
649370-4937098.930101.54
60min147734-4773495.65297.241.0798.70100.371.08
248349-4834996.88499.98
348857-4885797.902101.08
448233-4823396.65299.78
549136-4913698.461101.65
648842-4884297.872101.03
极限148087-4808796.35997.731.6399.94101.401.59
248887-4888797.962101.60
349013-4901398.215101.94
449208-4920898.606102.27
549814-4981499.820103.55
647623-4762395.42999.13
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(%)99.70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%
111.513949773971863966133940723971833960060.36
211.443981213964343972780.31
单位质量响应值RSD%判断
34405.3934727.100.66数据可信
加速1月-供试品溶液-24051503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%
5min1109479-10947928.42030.539.8728.4230.539.87
2118217-11821730.68830.69
3110008-11000828.55728.56
4109723-10972328.48328.48
5139633-13963336.24836.25
6118509-11850930.76430.76
10min1265540-26554068.93371.673.1469.0971.843.15
2274300-27430071.20771.38
3272674-27267470.78570.94
4270813-27081370.30170.46
5286652-28665274.41374.61
6286549-28654974.38674.56
15min1297110-29711077.12878.662.8177.6779.222.82
2296982-29698277.09577.66
3297117-29711777.13077.68
4299903-29990377.85378.40
5309647-30964780.38381.00
6317222-31722282.34982.93
20min1304656-30465679.08780.201.9780.0681.211.98
2306868-30686879.66180.66
3304552-30455279.06080.04
4306812-30681279.64780.63
5310209-31020980.52881.59
6320591-32059183.22484.27
30min1315333-31533381.85985.264.0183.2786.713.95
2327292-32729284.96386.40
3351419-35141991.22692.65
4316746-31674682.22583.65
5326603-32660384.78486.29
6333170-33317086.48987.99
45min1329959-32995985.65589.563.9987.5291.483.95
2356883-35688392.64594.55
3352870-35287091.60393.53
4325028-32502884.37586.26
5351378-35137891.21693.20
6353795-35379591.84393.83
60min1346001-34600189.82091.723.0292.1694.143.00
2358349-35834993.02595.45
3358427-35842793.04695.48
4334922-33492286.94489.29
5360625-36062593.61696.10
6361706-36170693.89796.39
极限1384362-38436299.77899.980.88102.62102.910.86
2386308-386308100.283103.22
3389309-389309101.062104.01
4383484-38348499.550102.38
5379829-37982998.601101.61
6387580-387580100.614103.63
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%
111.214489745152453444503645200451260.38
211.174533745404453700.11
单位质量响应值RSD%判断
4025.514061.770.64数据可信
加速1月-供试品溶液-2024052421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%
5min141198-4119882.34082.470.9982.3482.480.99
240743-4074381.43181.43
341281-4128182.50682.51
441968-4196883.87983.88
541347-4134782.63882.64
641055-4105582.05582.05
10min147590-4759095.11693.261.0995.5793.721.08
246140-4614092.21892.67
346846-4684693.62994.09
446417-4641792.77193.24
546496-4649692.92993.39
646492-4649292.92193.38
15min147139-4713994.21493.840.9895.2094.810.98
246674-4667493.28594.25
347582-4758295.10096.08
447221-4722194.37895.36
546801-4680193.53994.51
646285-4628592.50793.48
20min147674-4767495.28494.451.1696.7995.951.14
246473-4647392.88394.37
346716-4671693.36994.88
447539-4753995.01496.52
547320-4732094.57696.07
647826-4782695.58797.07
30min145777-4577791.49293.391.4893.5395.421.45
246656-4665693.24995.25
346273-4627392.48394.51
446885-4688593.70795.74
547822-4782295.57997.60
646951-4695193.83995.86
45min147287-4728794.51095.371.7797.0697.911.73
246758-4675893.45395.97
346988-4698893.91396.45
447935-4793595.80598.36
548831-4883197.596100.15
648504-4850496.94299.48
60min149052-4905298.03895.822.19101.1198.902.12
248012-4801295.95999.00
346254-4625492.44695.51
447745-4774595.42598.51
547559-4755995.05498.15
649040-4904098.014101.09
极限148983-4898397.90096.821.01101.52100.420.99
248422-4842296.779100.35
347584-4758495.10498.68
448831-4883197.596101.21
548429-4842996.793100.41
648410-4841096.755100.38
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(%)99.70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%
111.513963923959333958433971943966843964090.15
211.443969203972133970660.06
单位质量响应值RSD%判断
34440.4034708.570.55数据可信
加速1月-供试品溶液-2024052421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%
5min1108137-10813728.06531.2510.7128.0631.2510.71
2107758-10775827.96627.97
3136052-13605235.31035.31
4131875-13187534.22634.23
5127700-12770033.14233.14
6110880-11088028.77728.78
10min1267460-26746069.41473.474.3869.5773.644.39
2270322-27032270.15770.31
3297494-29749477.20977.40
4280983-28098372.92473.11
5294171-29417176.34676.53
6288136-28813674.78074.94
15min1295008-29500876.56479.233.3477.1179.813.36
2293757-29375776.23976.78
3319925-31992583.03083.66
4302074-30207478.39778.99
5311444-31144480.82981.44
6309443-30944380.31080.89
20min1304569-30456979.04581.043.4280.0182.073.42
2298961-29896177.59078.56
3324502-32450284.21885.30
4304998-30499879.15680.19
5320178-32017883.09684.15
6320440-32044083.16484.19
30min1303165-30316578.68182.803.9380.0984.283.93
2309233-30923380.25581.66
3329872-32987285.61287.17
4312812-31281281.18482.65
5334947-33494786.92988.45
6324283-32428384.16185.64
45min1339032-33903287.98988.103.2689.8390.033.24
2324310-32431084.16886.01
3341159-34115988.54190.57
4329792-32979285.59187.51
5349163-34916390.61892.62
6353237-35323791.67693.63
60min1350072-35007290.85490.083.8793.1992.503.81
2334572-33457286.83289.14
3340522-34052288.37690.90
4335281-33528187.01689.41
5351976-35197691.34993.85
6370093-37009396.05098.51
极限1381554-38155499.025101.261.98101.86104.181.97
2389353-389353101.049103.84
3386262-386262100.247103.26
4387007-387007100.440103.32
5392773-392773101.937104.95
6403951-403951104.838107.83
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