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%
114.131200091196201194751193971195081196020.21
214.101186521186071186300.03
单位质量响应值RSD%判断
8464.408413.480.43数据可信
供试品溶液-2024082021批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min181299-8129960.82664.073.1460.8364.083.14
287125-8712565.18565.19
384974-8497463.57663.58
487122-8712265.18365.18
588921-8892166.52966.53
684399-8439963.14663.15
10min1107181-10718180.19176.553.0380.2976.663.03
299758-9975874.63774.75
399185-9918574.20874.31
4103726-10372677.60677.71
5103753-10375377.62677.74
6100320-10032075.05875.16
15min1105498-10549878.93278.041.2879.1778.281.28
2103421-10342177.37877.61
3102030-10203076.33776.57
4104761-10476178.38078.62
5105218-10521878.72278.96
6104930-10493078.50778.74
20min1106343-10634379.56479.820.8079.9380.190.80
2105560-10556078.97879.34
3106014-10601479.31879.67
4107082-10708280.11780.49
5107516-10751680.44180.81
6107622-10762280.52180.88
30min1111179-11117983.18282.561.2483.6883.061.24
2109268-10926881.75282.25
3108509-10850981.18481.67
4109807-10980782.15682.66
5111271-11127183.25183.76
6112050-11205083.83484.33
45min1115295-11529586.26285.081.7786.9085.711.77
2113332-11333284.79385.42
3109830-10983082.17382.80
4114483-11448385.65486.29
5114894-11489485.96286.61
6114438-11443885.62086.26
60min1117081-11708187.59886.972.5888.3887.742.57
2115962-11596286.76187.53
3110479-11047982.65883.42
4116852-11685287.42688.21
5118289-11828988.50289.29
6118762-11876288.85589.63
90min1120306-12030690.01189.830.8790.9490.750.87
2119638-11963889.51190.43
3118916-11891688.97189.87
4119265-11926589.23290.16
5120475-12047590.13791.07
6121790-12179091.12192.05
120min1120502-12050290.15789.611.2791.2390.681.27
2119148-11914889.14490.21
3117476-11747687.89388.94
4118932-11893288.98390.06
5121270-12127090.73291.82
6121298-12129890.75391.83
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1122331-12233191.52690.471.6092.7591.691.59
2117812-11781288.14589.36
3119789-11978989.62490.82
4120548-12054890.19291.42
5122048-12204891.31492.55
6122977-12297792.00993.24
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%
114.131190591191631189191191021194931191470.18
214.101173741174081173910.03
单位质量响应值RSD%判断
8432.208325.600.90数据可信
供试品溶液-AV0080F批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1183931-183931138.604138.5810.38138.60138.5810.38
2189755-189755142.993142.99
3212140-212140159.861159.86
4187390-187390141.211141.21
5176680-176680133.140133.14
6153503-153503115.675115.67
10min1418123-418123315.083317.796.27315.31318.026.27
2423275-423275318.965319.20
3465722-465722350.952351.22
4426517-426517321.409321.64
5412735-412735311.023311.24
6383888-383888289.285289.48
15min1625767-625767471.557488.625.99472.31489.385.99
2626877-626877472.393473.16
3682470-682470514.286515.14
4676597-676597509.860510.63
5686443-686443517.280518.02
6592331-592331446.360447.04
20min1800678-800678603.363609.803.95604.91611.383.95
2807246-807246608.313609.87
3867711-867711653.877655.59
4812246-812246612.081613.70
5795710-795710599.620601.22
6771745-771745581.561582.98
30min11093963-1093963824.373834.852.80826.92837.442.80
21098454-1098454827.757830.33
31169868-1169868881.572884.37
41099217-1099217828.332830.97
51084529-1084529817.264819.87
61101152-1101152829.790832.18
45min11444643-14446431088.6331087.652.491092.551091.642.50
21442808-14428081087.2511091.20
31511097-15110971138.7111142.98
41431066-14310661078.4021082.42
51423277-14232771072.5331076.50
61407162-14071621060.3891064.16
60min11706520-17065201285.9751284.612.131291.711290.412.13
21700833-17008331281.6891287.45
31774500-17745001337.2021343.37
41690110-16901101273.6091279.43
51681231-16812311266.9181272.67
61675089-16750891262.2891267.83
90min12106223-21062231587.1771585.111.691595.061593.051.70
22094333-20943331578.2171586.12
32172092-21720921636.8141645.21
42093931-20939311577.9141585.86
52079168-20791681566.7901574.65
62075165-20751651563.7731571.42
120min12403207-24032071810.9741806.111.571821.501816.691.57
22397924-23979241806.9931817.52
32465497-24654971857.9141869.04
42382066-23820661795.0431805.61
52357729-23577291776.7041787.18
62374126-23741261789.0601799.31
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12580146-25801461944.3091930.621.511957.851944.211.52
22558547-25585471928.0331941.57
32628692-26286921980.8921995.11
42541077-25410771914.8681928.43
52545515-25455151918.2131931.65
62517936-25179361897.4301910.66
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