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%
111.914691546891468904692746908469060.04
211.994677446737467560.06
单位质量响应值RSD%判断
3938.373899.580.70数据可信
长期3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%
5min140361-4036183.23484.921.5483.2384.921.54
241783-4178386.16686.17
340827-4082784.19584.19
440981-4098184.51384.51
542059-4205986.73686.74
641050-4105084.65584.65
10min146639-4663996.18196.311.9896.6496.781.97
247699-4769998.36798.85
345333-4533393.48793.96
446643-4664396.18996.66
546158-4615895.18995.67
647741-4774198.45398.92
15min147967-4796798.91997.622.2399.9298.632.21
247606-4760698.17599.20
345398-4539893.62194.61
448420-4842099.853100.86
547057-4705797.04398.05
647584-4758498.12999.15
20min148593-48593100.21097.302.67101.7698.862.64
246557-4655796.01297.58
345382-4538293.58895.10
447487-4748797.92999.49
546554-4655496.00597.56
648527-48527100.074101.64
30min147755-4775598.48296.802.09100.5998.882.08
247612-4761298.187100.29
345195-4519593.20395.23
447660-4766098.286100.39
546657-4665796.21898.30
646743-4674396.39598.51
45min145972-4597294.80596.072.5997.4698.702.55
247360-4736097.668100.32
344643-4464392.06494.61
447144-4714497.22299.87
546348-4634895.58198.20
648040-4804099.070101.72
60min148588-48588100.20096.642.88103.3899.812.84
247029-4702996.985100.18
344772-4477292.33095.39
447002-4700296.929100.12
545975-4597594.81197.96
647814-4781498.604101.81
极限148708-48708100.447102.002.73104.18105.702.67
248831-48831100.701104.43
348129-4812999.253102.82
449013-49013101.076104.80
550273-50273103.675107.35
651808-51808106.840110.59
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%
111.353917163916963920373926463919943920180.10
211.363898893908103903500.17
单位质量响应值RSD%判断
34539.0334361.800.37数据可信
长期3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%
5min187629-8762922.82427.0712.0522.8227.0712.05
2102393-10239326.67026.67
3122758-12275831.97431.97
493606-9360624.38124.38
5110870-11087028.87828.88
6106297-10629727.68627.69
10min1255293-25529366.49470.665.2766.6270.815.28
2266923-26692369.52469.67
3286405-28640574.59874.78
4255608-25560866.57666.71
5276770-27677072.08872.25
6286740-28674074.68574.84
15min1302376-30237678.75880.572.4079.2581.122.38
2305546-30554679.58380.12
3310231-31023180.80481.40
4319981-31998183.34383.85
5302040-30204078.67079.23
6315939-31593982.29082.86
20min1315626-31562682.20982.232.3983.1483.222.36
2311408-31140881.11082.09
3314433-31443381.89882.94
4323708-32370884.31485.28
5304666-30466679.35480.35
6324478-32447884.51585.54
30min1328363-32836385.52684.672.9186.9286.122.86
2319399-31939983.19284.62
3321801-32180183.81785.31
4336281-33628187.58989.03
5311103-31110381.03182.47
6333466-33346686.85688.35
45min1341030-34103088.82686.223.0990.6988.143.03
2322272-32227283.94085.83
3325117-32511784.68186.64
4342556-34255689.22391.15
5318807-31880783.03784.93
6336383-33638387.61589.59
60min1359162-35916293.54887.844.0795.9190.243.97
2325998-32599884.91087.27
3331188-33118886.26288.69
4345986-34598690.11792.54
5322433-32243383.98286.33
6338777-33877788.23990.70
极限1377211-37721198.250100.502.33101.13103.382.31
2378691-37869198.635101.46
3389321-389321101.404104.32
4386233-386233100.599103.52
5381946-38194699.483102.30
6401620-401620104.607107.56
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%
111.914690246912469344689146916469110.04
211.994705247053470520.01
单位质量响应值RSD%判断
3938.793924.270.27数据可信
长期3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%
5min140488-4048883.22784.866.0483.2384.866.04
240519-4051983.29183.29
337667-3766777.42977.43
442811-4281188.00388.00
545081-4508192.66992.67
641129-4112984.54584.55
10min146055-4605594.67196.031.3595.1396.501.35
246174-4617494.91695.38
347298-4729897.22697.66
447536-4753697.71598.20
546953-4695396.51797.03
646288-4628895.15095.62
15min147273-4727397.17597.781.6598.1698.781.61
247456-4745697.55198.54
348599-4859999.901100.87
448292-4829299.269100.30
546418-4641895.41796.47
647357-4735797.34798.35
20min146752-4675296.10497.191.6397.6398.741.62
247512-4751297.66699.20
347367-4736797.36898.89
448667-48667100.040101.62
546576-4657695.74297.32
646821-4682196.24697.78
30min147640-4764097.92997.441.1799.9999.531.16
246875-4687596.35798.43
347755-4775598.166100.23
448216-4821699.113101.25
546840-4684096.28598.40
647094-4709496.80798.88
45min147307-4730797.24597.371.6599.85100.001.62
247935-4793598.536101.15
347646-4764697.942100.55
448381-4838199.452102.14
546429-4642995.44098.09
646511-4651195.60898.22
60min146769-4676996.13997.081.5699.29100.251.54
247193-4719397.010100.17
347789-4778998.235101.39
448382-4838299.454102.70
546426-4642695.43498.61
646794-4679496.19099.33
极限147865-4786598.392101.913.75102.07105.623.66
248943-48943100.608104.30
350498-50498103.804107.51
452923-52923108.789112.58
548529-4852999.757103.46
648691-48691100.090103.77
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%
111.353911553917733919923917423919363917200.09
211.363935553936283935920.02
单位质量响应值RSD%判断
34512.7834647.180.28数据可信
长期3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%
5min1107284-10728427.83927.0017.8127.8427.0017.81
287861-8786122.79922.80
376454-7645419.83919.84
4122299-12229931.73531.73
5122261-12226131.72531.73
6108210-10821028.07928.08
10min1284154-28415473.73468.809.7873.8968.959.80
2242667-24266762.96963.10
3223004-22300457.86757.98
4283241-28324173.49773.67
5281446-28144673.03173.21
6276365-27636571.71371.87
15min1321206-32120683.34979.133.0583.9179.673.07
2298715-29871577.51277.99
3297163-29716377.11077.54
4307934-30793479.90580.49
5297581-29758177.21877.80
6307191-30719179.71280.27
20min1332782-33278286.35281.233.3687.3882.203.37
2309153-30915380.22181.13
3305396-30539679.24680.11
4315312-31531281.81982.85
5303993-30399378.88279.89
6311557-31155780.84581.84
30min1341828-34182888.70083.223.3890.2184.643.38
2312836-31283681.17782.53
3318822-31882282.73084.03
4319682-31968282.95384.44
5312370-31237081.05682.50
6318765-31876582.71584.16
45min1349753-34975390.75685.173.4192.7687.063.38
2328087-32808785.13486.94
3326010-32601084.59586.36
4325004-32500484.33486.28
5317382-31738282.35684.26
6323055-32305583.82885.73
60min1355825-35582592.33286.513.5994.8488.873.55
2330889-33088985.86188.14
3334221-33422186.72688.96
4328205-32820585.16587.58
5320405-32040583.14185.50
6330831-33083185.84688.22
极限1385615-385615100.06298.530.87103.08101.370.91
2377439-37743997.940100.69
3381038-38103898.874101.59
4376516-37651697.701100.59
5378447-37844798.202101.02
6379305-37930598.424101.27
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%
111.914696946903469054681746828468840.14
211.994697647036470060.10
单位质量响应值RSD%判断
3936.523920.430.29数据可信
长期3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%
5min141721-4172185.82984.174.2085.8384.174.20
242633-4263387.70587.70
339347-3934780.94580.94
440538-4053883.39583.40
542678-4267887.79787.80
638580-3858079.36779.37
10min148470-4847099.71396.142.81100.1996.612.80
245705-4570594.02594.51
346469-4646995.59696.05
445924-4592494.47594.94
548277-4827799.31699.80
645557-4555793.72094.16
15min148667-48667100.11898.532.23101.1599.532.23
248647-48647100.077101.09
346807-4680796.29297.27
448715-48715100.217101.21
548222-4822299.203100.24
646300-4630095.24996.21
20min148983-48983100.76898.951.99102.36100.501.99
248829-48829100.451102.02
346843-4684396.36697.88
448995-48995100.793102.34
547671-4767198.06999.66
647269-4726997.24298.73
30min148762-48762100.31498.841.62102.46100.941.64
248685-48685100.155102.28
347206-4720697.11399.16
448446-4844699.663101.77
548223-4822399.205101.34
646948-4694896.58298.61
45min148610-48610100.00198.162.37102.70100.812.35
249143-49143101.097103.78
346328-4632895.30697.90
448345-4834599.456102.11
546942-4694296.56999.26
646921-4692196.52699.09
60min148560-4856099.89898.271.85103.16101.461.84
248961-48961100.723103.96
346521-4652195.70398.82
447744-4774498.219101.43
547502-4750297.721100.94
647322-4732297.351100.45
极限150594-50594104.082100.942.50107.90104.682.48
249975-49975102.809106.61
347386-4738697.483101.13
449677-49677102.196105.95
548747-48747100.283104.05
648034-4803498.816102.46
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%
111.353913603923163920413912923902683914550.21
211.363938253930403934320.15
单位质量响应值RSD%判断
34489.4334633.100.30数据可信
长期3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%
5min1111865-11186529.04330.596.4329.0430.596.43
2126446-12644632.82932.83
3125262-12526232.52132.52
4111212-11121228.87428.87
5122069-12206931.69231.69
6110105-11010528.58628.59
10min1277691-27769172.09674.023.9772.2674.203.97
2294753-29475376.52676.71
3300707-30070778.07278.25
4276056-27605671.67271.83
5288686-28868674.95175.13
6272802-27280270.82770.99
15min1296189-29618976.89980.503.1777.4681.093.17
2315873-31587382.00982.62
3323906-32390684.09584.71
4314152-31415281.56282.12
5305627-30562779.34979.94
6304718-30471879.11379.67
20min1303932-30393278.90982.362.7479.9083.392.73
2321840-32184083.55884.62
3327426-32742685.00986.09
4322411-32241183.70784.72
5310379-31037980.58381.62
6317344-31734482.39183.38
30min1309479-30947980.34984.413.1881.7885.903.17
2336454-33645487.35388.88
3333744-33374486.64988.20
4330471-33047185.79987.28
5318252-31825282.62784.11
6322266-32226683.66985.12
45min1315879-31587982.01186.855.1983.8888.805.14
2357519-35751992.82294.83
3352419-35241991.49893.53
4335397-33539787.07889.03
5318616-31861682.72184.66
6327174-32717484.94386.86
60min1341735-34173588.72489.444.3691.0591.884.32
2363409-36340994.35196.88
3362005-36200593.98696.53
4336892-33689287.46689.90
5326257-32625784.70587.10
6336704-33670487.41789.80
极限1378961-37896198.38999.481.74101.21102.411.78
2389317-389317101.077104.13
3390718-390718101.441104.51
4386306-386306100.295103.22
5373910-37391097.07799.95
6379686-37968698.577101.45
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%
111.914696146911469994708446893469700.17
211.994692446907469160.03
单位质量响应值RSD%判断
3943.743912.930.56数据可信
长期3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%
5min143793-4379390.09679.0029.1090.1079.0029.10
215773-1577332.45032.45
343631-4363189.76289.76
442256-4225686.93386.93
544423-4442391.39291.39
640537-4053783.39783.40
10min148217-4821799.19794.499.4899.7094.929.57
237279-3727976.69476.87
348622-48622100.030100.53
446910-4691096.50896.99
548436-4843699.648100.16
646096-4609694.83495.30
15min148282-4828299.33197.565.57100.3898.535.69
242470-4247087.37487.98
349631-49631102.106103.16
447806-4780698.35299.37
549473-49473101.781102.84
646880-4688096.44697.44
20min148935-48935100.67497.605.78102.2899.115.90
242206-4220686.83187.92
349699-49699102.246103.87
447641-4764198.01299.58
549075-49075100.962102.59
647087-4708796.87298.40
30min148918-48918100.63998.364.43102.80100.404.56
244339-4433991.21992.79
350258-50258103.396105.59
447728-4772898.191100.30
549052-49052100.915103.10
646559-4655995.78697.85
45min147752-4775298.24097.673.67100.96100.263.80
244833-4483392.23594.32
349633-49633102.110104.87
446917-4691796.52399.18
549052-49052100.915103.66
646663-4666396.00098.60
60min148463-4846399.70396.424.07102.9799.554.21
243565-4356589.62692.22
347687-4768798.107101.44
447038-4703896.77299.96
548592-4859299.969103.28
645843-4584394.31397.44
极限148965-48965100.73699.845.09104.56103.515.18
244233-4423391.00194.09
350876-50876104.667108.54
448997-48997100.802104.53
550709-50709104.324108.19
647391-4739197.498101.15
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%
111.353926193928833928073916873925173925030.13
211.363917633919033918330.03
单位质量响应值RSD%判断
34581.7634492.340.19数据可信
长期3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%
5min1122095-12209531.72125.8018.6131.7225.8018.61
270449-7044918.30318.30
3112982-11298229.35429.35
492499-9249924.03224.03
5106668-10666827.71327.71
691136-9113623.67823.68
10min1289567-28956775.23269.737.8575.4169.877.87
2236602-23660261.47161.57
3285702-28570274.22874.39
4249680-24968064.86965.00
5270049-27004970.16170.31
6278650-27865072.39672.53
15min1315451-31545181.95779.103.9182.5579.633.94
2281474-28147473.12973.57
3308071-30807180.03980.61
4303731-30373178.91279.41
5309961-30996180.53081.07
6308066-30806680.03880.57
20min1324746-32474684.37281.213.3185.4282.183.35
2293409-29340976.23077.08
3313133-31313381.35582.37
4313432-31343281.43282.36
5315908-31590882.07683.07
6314719-31471981.76782.75
30min1331212-33121286.05284.372.3287.5785.782.34
2315838-31583882.05783.33
3318783-31878382.82284.29
4325363-32536384.53285.92
5335503-33550387.16688.61
6321628-32162883.56284.99
45min1332614-33261486.41686.043.3588.4187.933.30
2328170-32817085.26186.99
3319471-31947183.00184.93
4326448-32644884.81486.67
5351986-35198691.44993.38
6328276-32827685.28987.19
60min1343974-34397489.36786.624.5391.8488.994.47
2322818-32281883.87186.07
3310052-31005280.55482.95
4334524-33452486.91289.24
5352305-35230591.53293.97
6336796-33679687.50289.87
极限1398246-398246103.46899.014.62106.44101.864.59
2346858-34685890.11792.79
3383779-38377999.709102.55
4384170-38417099.811102.62
5387975-387975100.799103.75
6385453-385453100.144103.00
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