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 100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.991200091196201194751193971195081196020.21
216.011186521186071186300.03
单位质量响应值RSD%判断
7479.807409.740.67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%
5min181299-8129960.87564.133.1460.8864.133.13
287125-8712565.23765.24
384974-8497463.62763.63
487122-8712265.23565.24
588921-8892166.58266.58
684399-8439963.19663.20
10min1107181-10718180.25576.623.0380.3676.723.03
299758-9975874.69774.81
399185-9918574.26874.37
4103726-10372677.66877.78
5103753-10375377.68877.80
6100320-10032075.11875.22
15min1105498-10549878.99578.111.2879.2378.341.28
2103421-10342177.44077.67
3102030-10203076.39876.63
4104761-10476178.44378.68
5105218-10521878.78579.03
6104930-10493078.57078.80
20min1106343-10634379.62879.890.8079.9980.250.80
2105560-10556079.04179.40
3106014-10601479.38179.74
4107082-10708280.18180.55
5107516-10751680.50680.88
6107622-10762280.58580.95
30min1111179-11117983.24982.631.2483.7583.121.24
2109268-10926881.81882.31
3108509-10850981.24981.74
4109807-10980782.22182.72
5111271-11127183.31883.82
6112050-11205083.90184.40
45min1115295-11529586.33185.151.7786.9785.781.77
2113332-11333284.86185.49
3109830-10983082.23982.86
4114483-11448385.72386.36
5114894-11489486.03086.68
6114438-11443885.68986.32
60min1117081-11708187.66887.042.5888.4587.822.57
2115962-11596286.83087.60
3110479-11047982.72483.49
4116852-11685287.49688.28
5118289-11828988.57289.36
6118762-11876288.92789.71
90min1120306-12030690.08389.900.8791.0190.820.87
2119638-11963889.58390.50
3118916-11891689.04289.94
4119265-11926589.30390.23
5120475-12047590.20991.15
6121790-12179091.19492.12
120min1120502-12050290.23089.681.2791.3190.751.27
2119148-11914889.21690.28
3117476-11747687.96489.01
4118932-11893289.05490.13
5121270-12127090.80591.89
6121298-12129890.82691.90
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1122331-12233191.59990.541.6092.8391.761.59
2117812-11781288.21589.43
3119789-11978989.69690.89
4120548-12054890.26491.49
5122048-12204891.38792.62
6122977-12297792.08393.31
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 100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.991190591191631189191191021194931191470.18
216.011173741174081173910.03
单位质量响应值RSD%判断
7451.347332.351.14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%
5min1183931-183931138.716138.6910.38138.72138.6910.38
2189755-189755143.108143.11
3212140-212140159.990159.99
4187390-187390141.325141.32
5176680-176680133.247133.25
6153503-153503115.768115.77
10min1418123-418123315.337318.046.27315.57318.276.27
2423275-423275319.223319.46
3465722-465722351.235351.50
4426517-426517321.668321.90
5412735-412735311.274311.50
6383888-383888289.518289.71
15min1625767-625767471.937489.025.99472.69489.785.99
2626877-626877472.774473.54
3682470-682470514.701515.55
4676597-676597510.271511.04
5686443-686443517.697518.44
6592331-592331446.720447.40
20min1800678-800678603.850610.293.95605.39611.873.95
2807246-807246608.803610.36
3867711-867711654.405656.11
4812246-812246612.574614.20
5795710-795710600.103601.71
6771745-771745582.030583.45
30min11093963-1093963825.038835.522.80827.59838.122.80
21098454-1098454828.425831.00
31169868-1169868882.283885.08
41099217-1099217829.000831.64
51084529-1084529817.923820.53
61101152-1101152830.460832.85
45min11444643-14446431089.5111088.532.491093.441092.522.50
21442808-14428081088.1271092.08
31511097-15110971139.6291143.90
41431066-14310661079.2721083.30
51423277-14232771073.3981077.36
61407162-14071621061.2441065.02
60min11706520-17065201287.0121285.652.131292.751291.452.13
21700833-17008331282.7231288.49
31774500-17745001338.2811344.45
41690110-16901101274.6361280.46
51681231-16812311267.9401273.70
61675089-16750891263.3081268.85
90min12106223-21062231588.4571586.391.691596.341594.331.70
22094333-20943331579.4901587.40
32172092-21720921638.1341646.53
42093931-20939311579.1871587.13
52079168-20791681568.0531575.92
62075165-20751651565.0341572.68
120min12403207-24032071812.4351807.571.571822.971818.161.57
22397924-23979241808.4501818.99
32465497-24654971859.4121870.54
42382066-23820661796.4911807.07
52357729-23577291778.1361788.62
62374126-23741261790.5031800.76
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12580146-25801461945.8771932.181.511959.431945.781.52
22558547-25585471929.5881943.14
32628692-26286921982.4891996.72
42541077-25410771916.4131929.99
52545515-25455151919.7601933.21
62517936-25179361898.9601912.20
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