坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.987858678507783247962178819787710.65
216.077765477759777060.10
单位质量响应值RSD%判断
4929.354835.471.36数据可信
供试品溶液-2025010921批-pH1.2(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13208-32083.6893.6811.933.693.6911.90
22884-28843.3163.32
33409-34093.9203.92
43483-34834.0054.01
53619-36194.1614.16
62625-26253.0183.02
15min15512-55126.3386.5810.846.346.5910.84
25218-52186.0006.01
35811-58116.6826.69
46035-60356.9406.95
56743-67437.7547.76
65031-50315.7855.79
20min18007-80079.2079.127.479.229.147.49
27102-71028.1678.18
37914-79149.1009.12
48391-83919.6499.67
58722-872210.02910.05
67459-74598.5778.59
30min111148-1114812.81912.893.7512.8512.923.77
211063-1106312.72112.75
311199-1119912.87812.91
411260-1126012.94812.98
511948-1194813.73913.78
610655-1065512.25212.28
45min114662-1466216.86016.842.0416.9116.892.05
214467-1446716.63616.69
314565-1456516.74816.80
414576-1457616.76116.82
515221-1522117.50317.56
614379-1437916.53416.58
60min117101-1710119.66419.441.5719.7519.521.58
216791-1679119.30819.39
316728-1672819.23519.32
416807-1680719.32619.41
517352-1735219.95320.04
616663-1666319.16119.24
极限119310-1931022.20521.662.1722.3221.772.19
218656-1865621.45221.56
318536-1853621.31421.43
418722-1872221.52821.64
519381-1938122.28622.41
618415-1841521.17521.28
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
115.987699777031769347694976682769190.18
216.077726077434773470.16
单位质量响应值RSD%判断
4813.454813.130.01数据可信
供试品溶液-2025010921批-pH4.5(内含1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13209-32093.7433.846.383.743.846.36
23446-34464.0194.02
32912-29123.3963.40
43400-34003.9653.97
53322-33223.8743.87
63474-34744.0524.05
10min16845-68457.9838.608.057.998.618.07
27674-76748.9508.96
36952-69528.1088.11
47194-71948.3908.40
57147-71478.3368.34
68436-84369.8399.85
15min112762-1276214.88416.156.8914.9016.176.89
213856-1385616.16016.18
313004-1300415.16715.19
414095-1409516.43916.46
513888-1388816.19816.22
615456-1545618.02618.05
20min119360-1936022.58024.186.5122.6224.226.51
220669-2066924.10624.15
319681-1968122.95423.00
420512-2051223.92323.97
520964-2096424.45024.50
623182-2318227.03727.09
30min131521-3152136.76339.325.1736.8439.405.18
234172-3417239.85539.94
333068-3306838.56738.65
432628-3262838.05438.14
534283-3428339.98440.07
636583-3658342.66742.77
45min146276-4627653.97255.613.2654.1255.763.26
247232-4723255.08755.24
346140-4614053.81353.96
447416-4741655.30155.45
548916-4891657.05157.21
650107-5010758.44058.61
60min156078-5607865.40466.631.8665.6466.881.87
257298-5729866.82767.07
355990-5599065.30165.54
456902-5690266.36566.61
557739-5773967.34167.59
658789-5878968.56668.83
极限161765-6176572.03772.671.7572.3873.021.76
262333-6233372.69973.06
360564-6056470.63670.98
462353-6235372.72273.08
563154-6315473.65774.02
663660-6366074.24774.63
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