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%
112.845047950495504595051750433504770.07
212.865059750526505620.10
单位质量响应值RSD%判断
3931.233931.730.01数据可信
供试品溶液-24040301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%
5min18785-878518.05939.6472.3718.0639.6472.38
226317-2631754.09854.10
36968-696814.32414.32
44891-489110.05410.05
534595-3459571.11471.11
634139-3413970.17770.18
10min140138-4013882.50978.9328.6482.6179.1528.74
246035-4603594.63194.93
329197-2919760.01860.10
420855-2085542.87042.93
546760-4676096.12196.52
647391-4739197.41897.81
15min145732-4573294.00890.1217.4794.5790.7817.58
246728-4672896.05596.88
344866-4486692.22892.64
428522-2852258.63158.92
548605-4860599.914100.84
648605-4860599.914100.84
20min149360-49360101.46697.136.53102.5598.306.72
248111-4811198.898100.26
348098-4809898.87299.80
441030-4103084.34284.96
548502-4850299.702101.19
648413-4841399.519101.01
30min145661-4566193.86297.142.9595.5198.843.09
246806-4680696.21698.13
348897-48897100.514101.99
445719-4571993.98195.07
548226-4822699.135101.17
648210-4821099.102101.14
45min147398-4739897.43397.261.5199.6099.501.78
246911-4691196.43298.88
347659-4765997.969100.00
446087-4608794.73896.35
547793-4779398.245100.83
648027-4802798.726101.32
60min148938-48938100.59897.962.23103.31100.742.38
248179-4817999.038102.02
348106-4810698.888101.47
445808-4580894.16496.30
547526-4752697.696100.83
647367-4736797.369100.51
极限149058-49058100.84599.081.79104.11102.401.42
247669-4766997.990101.52
347899-4789998.463101.59
449504-49504101.762104.42
547536-4753697.716101.39
647532-4753297.708101.39
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%
110.993831273831063830733832383829733831030.03
211.073840123840743840430.02
单位质量响应值RSD%判断
34859.2434692.230.34数据可信
供试品溶液-24040301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%
5min163796-6379616.46113.4030.1616.4613.4030.17
253344-5334413.76413.76
373639-7363919.00119.00
431504-315048.1298.13
538000-380009.8059.80
651239-5123913.22113.22
10min1120197-12019731.01448.3234.9631.1148.4034.92
2163428-16342842.16942.25
3263808-26380868.06968.17
4109156-10915628.16528.21
5225609-22560958.21358.27
6241413-24141362.29162.36
15min1251787-25178764.96879.4320.5065.2379.7720.53
2268639-26863969.31669.63
3348035-34803589.80290.29
4234638-23463860.54360.74
5367054-36705494.71095.09
6376754-37675497.21297.63
20min1330152-33015285.18891.997.4885.8192.787.57
2318700-31870082.23382.93
3383587-38358798.97699.96
4357141-35714192.15292.69
5371193-37119395.77896.68
6378340-37834097.62298.58
30min1336541-33654186.83694.714.9387.9396.004.99
2355738-35573891.79092.94
3385049-38504999.353100.89
4380934-38093498.29199.34
5369577-36957795.36196.80
6374415-37441596.60998.11
45min1361983-36198393.40195.741.6794.9897.561.79
2364991-36499194.17795.84
3376873-37687397.24399.33
4376253-37625397.08398.68
5372224-37222496.04498.01
6373956-37395696.49098.53
60min1363933-36393393.90496.071.3596.0098.421.42
2378056-37805697.54899.73
3376405-37640597.12299.75
4371558-37155895.87298.01
5373387-37338796.34498.84
6370519-37051995.60498.18
极限1373349-37334996.33496.931.3398.9599.821.26
2385254-38525499.406102.13
3376464-37646497.138100.30
4373594-37359496.39799.07
5371349-37134995.81898.85
6373999-37399996.50299.61
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%
112.845047750587505165058150539505400.10
212.865061150558505840.08
单位质量响应值RSD%判断
3936.143933.440.05数据可信
供试品溶液-24040301SP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%
5min131925-3192565.57178.019.0865.5778.019.08
238256-3825678.57478.57
336508-3650874.98474.98
439995-3999582.14682.15
539452-3945281.03081.03
641761-4176185.77385.77
10min146735-4673595.98996.403.9296.3596.833.89
247069-4706996.67597.11
347806-4780698.18998.61
448358-4835899.32399.78
548227-4822799.05399.50
643418-4341889.17689.65
15min146967-4696796.46698.222.6097.3699.192.59
246524-4652495.55696.53
347079-4707996.69697.66
447948-4794898.48099.49
549864-49864102.416103.42
648544-4854499.705100.68
20min146903-4690396.33499.022.0297.77100.542.03
247734-4773498.04199.55
347618-4761897.80399.30
448487-4848799.587101.14
549038-49038100.719102.29
649497-49497101.662103.19
30min149094-49094100.83499.721.31102.80101.791.28
248224-4822499.047101.10
347649-4764997.86699.91
448161-4816198.918101.03
548951-48951100.540102.67
649236-49236101.126103.22
45min147788-4778898.15299.372.48100.68101.992.45
247049-4704996.63499.23
347849-4784998.277100.86
447861-4786198.302100.96
550012-50012102.720105.41
649731-49731102.143104.79
60min145380-4538093.20696.612.8896.2899.782.85
246022-4602294.52597.66
346916-4691696.36199.49
446804-4680496.13199.33
549152-49152100.953104.21
647951-4795198.487101.71
极限147378-4737897.31099.111.84100.90102.811.82
248254-4825499.109102.77
348839-48839100.310103.98
446985-4698596.503100.24
549076-49076100.797104.62
648983-48983100.606104.37
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%
110.993838273841683839513842283839293840210.05
211.073846473846363846420.01
单位质量响应值RSD%判断
34942.7734746.340.40数据可信
供试品溶液-24040301SP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%
5min1111843-11184328.80147.4921.2028.8047.4821.20
2213593-21359355.00455.00
3201716-20171651.94551.95
4211148-21114854.37454.37
5168163-16816343.30543.30
6199966-19996651.49551.49
10min1188073-18807348.43277.2619.7348.5977.5219.72
2323726-32372683.36583.67
3280988-28098872.35972.65
4329620-32962084.88385.18
5330127-33012785.01385.25
6347612-34761289.51689.80
15min1270131-27013169.56385.4011.3169.9986.1011.36
2337633-33763386.94687.72
3304226-30422678.34379.03
4348803-34880389.82390.60
5363784-36378493.68194.39
6365235-36523594.05494.84
20min1289939-28993974.66487.529.3775.4888.699.44
2349311-34931189.95491.21
3311918-31191880.32481.45
4356309-35630991.75693.03
5359333-35933392.53493.77
6372285-37228595.87097.18
30min1318086-31808681.91389.506.3483.1491.156.45
2350827-35082790.34492.10
3322468-32246883.04184.61
4361749-36174993.15794.94
5362256-36225693.28795.03
6369856-36985695.24497.08
45min1327637-32763784.37290.835.4386.0692.985.54
2345052-34505288.85791.11
3336609-33660986.68388.72
4362028-36202893.22895.53
5369637-36963795.18897.45
6375294-37529496.64599.01
60min1331405-33140585.34290.003.6187.5092.663.79
2350655-35065590.30093.05
3337078-33707886.80389.32
4355233-35523391.47994.30
5361378-36137893.06195.86
6361269-36126993.03395.94
极限1367692-36769294.68796.391.6697.3299.541.78
2379557-37955797.742100.99
3374946-37494696.55599.55
4368850-36885094.98598.31
5371437-37143795.65198.96
6383330-38333098.714102.14
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%
112.845032650432503115033050399503600.11
212.865062550635506300.02
单位质量响应值RSD%判断
3922.123937.010.27数据可信
供试品溶液-24040301SP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%
5min117757-1775736.52042.1810.0336.5242.1810.02
223880-2388049.11249.11
320352-2035241.85741.86
419287-1928739.66639.67
521322-2132243.85243.85
620460-2046042.07942.08
10min139685-3968581.61887.536.3681.8287.776.36
242800-4280088.02488.30
343020-4302088.47788.71
442028-4202886.43686.66
547387-4738797.45897.70
640441-4044183.17283.41
15min146471-4647195.57495.633.6996.2396.353.68
248705-48705100.168100.93
343668-4366889.80990.53
447405-4740597.49598.20
547059-4705996.78397.57
645674-4567493.93594.63
20min147553-4755397.79997.472.7398.9998.722.74
249380-49380101.557102.88
346651-4665195.94497.17
446672-4667295.98797.23
548281-4828199.296100.62
645812-4581294.21995.44
30min147949-4794998.61498.142.76100.3499.932.77
249705-49705102.225104.11
346377-4637795.38197.14
447039-4703996.74298.52
548706-48706100.171102.04
646529-4652995.69397.43
45min146945-4694596.54998.452.4098.83100.792.42
249767-49767102.353104.80
347322-4732297.32499.61
447149-4714996.96899.28
548812-48812100.389102.82
647227-4722797.12999.40
60min147045-4704596.75498.542.1899.57101.432.20
249272-49272101.335104.35
347748-4774898.200101.03
446983-4698396.62799.48
549156-49156101.096104.08
647290-4729097.258100.07
极限148911-48911100.59299.572.52103.94103.002.47
249504-49504101.812105.39
347669-4766998.038101.41
446350-4635095.32598.71
548561-4856199.872103.42
649482-49482101.766105.12
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%
110.993828863830803828473825623826703828090.06
211.073847003849903848450.06
单位质量响应值RSD%判断
34832.4834764.680.14数据可信
供试品溶液-24040301SP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%
5min162310-6231016.06717.0912.4816.0717.0912.48
270279-7027918.12218.12
366946-6694617.26217.26
460383-6038315.57015.57
580275-8027520.69920.70
657392-5739214.79914.80
10min1242148-24214862.43954.5519.5362.5354.6419.48
2144568-14456837.27837.38
3234183-23418360.38560.48
4237817-23781761.32261.41
5175095-17509545.14945.26
6235512-23551260.72860.81
15min1356400-35640091.90083.6415.1492.3484.0315.12
2246189-24618963.48163.79
3331127-33112785.38385.81
4338181-33818187.20287.63
5290474-29047474.90075.27
6383721-38372198.94599.36
20min1370060-37006095.42292.565.0096.3793.424.98
2348220-34822089.79090.45
3341824-34182488.14189.05
4339327-33932787.49788.41
5373276-37327696.25197.03
6380952-38095298.23199.20
30min1373343-37334396.26995.084.5297.7596.464.44
2377717-37771797.39698.56
3345972-34597289.21190.61
4349679-34967990.16791.56
5383881-38388198.986100.30
6381875-38187598.46999.98
45min1362793-36279393.54895.044.0195.5696.943.93
2375977-37597796.94898.65
3352156-35215690.80592.70
4352578-35257890.91492.81
5382945-38294598.745100.61
6384914-38491499.252101.31
60min1362997-36299793.60195.293.7596.1397.723.68
2375167-37516796.73998.98
3356991-35699192.05294.45
4353004-35300491.02493.43
5385982-38598299.528101.94
6383045-38304598.770101.38
极限1378280-37828097.54297.611.13100.59100.571.17
2376581-37658197.10499.88
3371172-37117295.70998.62
4382303-38230398.579101.49
5380385-38038598.084101.05
6382493-38249398.628101.79
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