替米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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.987655217593847632307647207599287625570.37
210.957476437491277483850.15
单位质量响应值RSD%判断
69449.6468345.661.14数据可信
供试品溶液-2024070321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min178723-7872310.28410.546.1210.2810.546.13
272069-720699.4159.41
384902-8490211.09111.09
481809-8180910.68710.69
585618-8561811.18511.18
680980-8098010.57910.58
10min1147002-14700219.20419.655.5819.2619.715.57
2139731-13973118.25418.31
3156835-15683520.48820.55
4149430-14943019.52119.58
5163365-16336521.34221.40
6146345-14634519.11819.18
15min1204606-20460626.72927.874.9626.8928.044.96
2209605-20960527.38227.54
3214641-21464128.04028.22
4219800-21980028.71428.88
5230012-23001230.04830.23
6201212-20121226.28626.45
20min1266285-26628534.78736.482.8235.1036.812.82
2276675-27667536.14436.45
3277212-27721236.21436.55
4288887-28888737.73938.07
5284846-28484637.21137.56
6281778-28177836.81137.12
30min1346209-34620945.22849.394.8845.7349.924.83
2401915-40191552.50553.01
3372200-37220048.62349.16
4380956-38095649.76750.30
5381229-38122949.80350.36
6385912-38591250.41450.93
45min1450517-45051758.85464.726.2559.6165.526.19
2545498-54549871.26272.06
3502018-50201865.58266.38
4485376-48537663.40864.22
5486782-48678263.59264.42
6502214-50221465.60866.40
60min1527106-52710668.86076.355.7169.9477.515.68
2617999-61799980.73381.93
3606120-60612079.18280.35
4593133-59313377.48578.65
5598334-59833478.16579.35
6564116-56411673.69474.85
极限1615914-61591480.46186.504.6081.9388.084.59
2690569-69056990.21491.86
3672138-67213887.80689.41
4679387-67938788.75390.35
5682277-68227789.13190.75
6632340-63234082.60784.18
替米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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.987485817501407499117479887497837492810.13
210.957532217480397506300.49
单位质量响应值RSD%判断
68240.5368550.680.33数据可信
供试品溶液-2024070321批-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%
5min1194491-19449125.59327.253.1425.5927.253.15
2212316-21231627.93827.94
3209717-20971727.59627.60
4206112-20611227.12227.12
5209379-20937927.55227.55
6210599-21059927.71227.71
10min1361933-36193347.62650.213.9547.7750.363.94
2385097-38509750.67450.83
3393540-39354051.78551.94
4382997-38299750.39850.55
5400092-40009252.64752.80
6365875-36587548.14548.30
15min1529087-52908769.62268.223.3970.0368.663.38
2508897-50889766.96567.40
3529513-52951369.67870.12
4511824-51182467.35067.78
5539815-53981571.03371.48
6491673-49167364.69865.12
20min1628377-62837782.68782.902.3483.4883.712.33
2617161-61716181.21182.02
3631261-63126183.06683.89
4618390-61839081.37382.18
5657670-65767086.54287.38
6627158-62715882.52783.31
30min1743990-74399097.90095.982.0199.1597.251.99
2736470-73647096.91198.17
3733133-73313396.47297.76
4722612-72261295.08796.34
5737084-73708496.99198.31
6703261-70326192.54193.78
45min1713583-71358393.89995.231.9395.7097.031.89
2733776-73377696.55698.35
3699829-69982992.08993.91
4734166-73416696.60798.39
5731439-73143996.24998.11
6729325-72932595.97097.72
60min1730140-73014096.07895.562.1398.4097.902.09
2731957-73195796.31798.65
3719669-71966994.70097.04
4700870-70087092.22694.55
5747464-74746498.357100.75
6727245-72724595.69797.98
极限1726390-72639095.58494.811.4898.4497.671.40
2727264-72726495.69998.57
3712602-71260293.77096.63
4725426-72542695.45798.29
5702399-70239992.42795.37
6728878-72887895.91298.73
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