缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.131210351210211208071207541206651208560.14
214.101205101203881204490.08
单位质量响应值RSD%判断
8553.158542.480.09数据可信
供试品溶液-2024082021批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min123292-2329217.20516.316.8217.2016.316.82
223156-2315617.10417.10
323646-2364617.46617.47
420101-2010114.84714.85
520597-2059715.21415.21
621725-2172516.04716.05
10min143591-4359132.19831.135.0132.2331.165.01
243862-4386232.39832.43
344435-4443532.82232.85
439401-3940129.10329.13
540193-4019329.68829.71
641378-4137830.56430.59
15min157286-5728642.31441.103.8942.4041.183.89
257386-5738642.38842.47
358062-5806242.88742.97
453251-5325139.33439.41
553639-5363939.62039.70
654206-5420640.03940.12
20min169327-6932751.20848.754.5551.3648.904.55
269881-6988151.61751.77
366216-6621648.91049.07
463441-6344146.86047.00
564091-6409147.34047.48
663057-6305746.57746.72
30min185246-8524662.96760.983.7163.2061.213.71
285726-8572663.32163.56
384543-8454362.44762.68
480862-8086259.72859.95
580879-8087959.74159.96
678092-7809257.68257.90
45min1105459-10545977.89773.394.6778.2473.724.67
2100998-10099874.60274.95
3102770-10277075.91176.25
497670-9767072.14372.46
596635-9663571.37971.70
692592-9259268.39368.71
60min1116017-11601785.69581.744.4086.1782.204.39
2113670-11367083.96284.43
3114723-11472384.74085.21
4106972-10697279.01479.45
5108763-10876380.33780.78
6103834-10383476.69677.13
90min1127258-12725893.99892.342.5394.6192.922.54
2127548-12754894.21394.82
3128487-12848794.90695.51
4123011-12301190.86191.43
5123025-12302590.87291.44
6120726-12072689.17489.73
120min1130354-13035496.28594.041.5097.0694.781.51
2127305-12730594.03394.80
3127311-12731194.03894.80
4127197-12719793.95394.67
5127411-12741194.11194.84
6124324-12432491.83192.54
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1133671-13367198.73596.521.8199.6797.421.83
2133024-13302498.25799.18
3131166-13116696.88597.81
4128158-12815894.66395.54
5129820-12982095.89196.77
6128201-12820194.69595.56
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.131200751202731204391203851197891201920.23
214.101214721205481210100.54
单位质量响应值RSD%判断
8506.168582.270.63数据可信
供试品溶液-AV0080F批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11556301-15563011150.0611127.343.531150.061127.343.53
21500656-15006561108.9411108.94
31502092-15020921110.0021110.00
41620278-16202781197.3381197.34
51473471-14734711088.8521088.85
61500521-15005211108.8411108.84
10min12668915-26689151972.2501931.733.961974.171933.613.96
22569473-25694731898.7651900.61
32593812-25938121916.7511918.60
42785395-27853952058.3252060.32
52480138-24801381832.7491834.56
62586777-25867771911.5521913.40
15min13367076-33670762488.1702413.122.392493.372418.222.39
23242203-32422032395.8932400.91
33268147-32681472415.0642420.11
43311480-33114802447.0862452.51
53133846-31338462315.8202320.69
63270349-32703492416.6922421.73
20min13823060-38230602825.1292744.882.322834.482754.002.32
23688797-36887972725.9122734.92
33726102-37261022753.4802762.55
43763873-37638732781.3912790.90
53566068-35660682635.2192643.95
63718851-37188512748.1212757.18
30min14432315-44323153275.3503170.242.383289.413183.942.38
24260506-42605063148.3893161.94
34298337-42983373176.3453190.00
44338240-43382403205.8323219.97
54121429-41214293045.6153058.74
64289656-42896563169.9303183.57
45min14861622-48616223592.5963506.291.933612.113525.271.93
24707389-47073893478.6223497.42
34770200-47702003525.0373543.99
44785768-47857683536.5423556.03
54589411-45894113391.4403409.64
64754618-47546183513.5233532.45
60min15085716-50857163758.1943680.111.713783.703704.931.71
24940554-49405543650.9243675.52
35013402-50134023704.7573729.58
45016609-50166093707.1263732.50
54835827-48358273573.5343597.38
64988157-49881573686.1013710.88
90min15266390-52663903891.7073823.721.643923.483854.681.65
25109880-51098803776.0513806.73
35207093-52070933847.8893878.89
45246345-52463453876.8953908.45
55044029-50440293727.3893757.19
65172586-51725863822.3893853.31
120min15305363-53053633920.5073851.621.343958.763888.951.34
25177193-51771933825.7933862.77
35247438-52474383877.7023915.12
45212124-52121243851.6063889.62
55100148-51001483768.8593804.88
65230623-52306233865.2773902.57
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限15324789-53247893934.8623873.461.243979.653917.211.24
25287266-52872663907.1343950.48
35243398-52433983874.7173918.60
45237198-52371983870.1353914.57
55134201-51342013794.0233836.32
65223325-52233253859.8843903.62
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.131207341205621206491203741203631205360.14
214.101206481209091207780.16
单位质量响应值RSD%判断
8530.508565.820.30数据可信
供试品溶液-8194970批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1138081-138081101.989109.064.79101.99109.064.79
2147116-147116108.663108.66
3147503-147503108.948108.95
4159856-159856118.073118.07
5144821-144821106.967106.97
6148563-148563109.731109.73
10min1199524-199524147.372160.964.85147.54161.154.85
2217159-217159160.398160.58
3220539-220539162.894163.08
4231947-231947171.320171.52
5216769-216769160.109160.29
6221606-221606163.682163.87
15min1222741-222741164.521177.174.21164.94177.624.21
2242938-242938179.438179.89
3243262-243262179.678180.13
4253607-253607187.319187.80
5238563-238563176.207176.65
6238125-238125175.883176.34
20min1237504-237504175.425185.853.49176.11186.603.50
2253340-253340187.121187.87
3256312-256312189.317190.07
4263863-263863194.894195.69
5248991-248991183.909184.65
6249692-249692184.427185.18
30min1256941-256941189.781193.752.52190.76194.812.52
2264044-264044195.028196.09
3266750-266750197.026198.09
4272542-272542201.304202.42
5256071-256071189.139190.18
6257569-257569190.245191.30
45min1261656-261656193.264194.942.25194.56196.322.26
2265762-265762196.297197.68
3267092-267092197.279198.68
4273084-273084201.705203.16
5259140-259140191.405192.77
6256797-256797189.675191.05
60min1264569-264569195.415196.121.95197.04197.831.95
2268137-268137198.051199.76
3268980-268980198.673200.40
4272207-272207201.057202.85
5259484-259484191.660193.34
6259796-259796191.890193.58
90min1266878-266878197.121197.191.52199.07199.221.52
2269859-269859199.323201.36
3268602-268602198.394200.45
4272033-272033200.928203.05
5262124-262124193.609195.61
6262342-262342193.771195.78
120min1261222-261222192.943193.911.78195.22196.261.78
2264513-264513195.374197.75
3265802-265802196.326198.71
4268748-268748198.502200.96
5258189-258189190.703193.02
6256686-256686189.593191.93
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1265288-265288195.946193.911.41198.54196.591.40
2263657-263657194.742197.44
3265158-265158195.850198.56
4265379-265379196.014198.81
5257778-257778190.399193.04
6257901-257901190.490193.14
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