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%
116.133790738009378153801638000379490.23
216.103833237982381570.65
单位质量响应值RSD%判断
2352.702370.000.52数据可信
供试品溶液-2025030321批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13164-31647.5228.6518.327.528.6518.31
23534-35348.4028.40
33933-39339.3509.35
42792-27926.6386.64
53683-36838.7568.76
64725-472511.23311.23
10min15440-544012.93312.7815.6812.9512.7915.67
25684-568413.51313.53
34111-41119.7739.79
44716-471611.21211.22
56479-647915.40315.42
65818-581813.83213.85
15min19572-957222.75621.6212.4222.7921.6612.41
28307-830719.74919.79
37476-747617.77317.81
48722-872220.73620.77
510483-1048324.92224.96
610013-1001323.80523.85
20min113428-1342831.92330.609.6332.0030.679.62
211902-1190228.29628.37
311035-1103526.23426.30
412801-1280130.43330.50
514458-1445834.37234.45
613597-1359732.32532.41
30min119180-1918045.59844.705.1745.7244.825.18
218149-1814943.14743.26
317243-1724340.99341.10
418875-1887544.87344.99
519977-1997747.49347.63
619382-1938246.07846.21
45min125560-2556060.76659.923.3760.9760.123.38
224551-2455158.36758.56
323903-2390356.82757.00
425312-2531260.17660.37
526286-2628662.49262.71
625616-2561660.89961.11
60min130042-3004271.42170.292.5971.7270.592.61
229106-2910669.19669.48
328285-2828567.24467.51
429871-2987171.01571.30
530428-3042872.33972.66
629675-2967570.54970.86
极限131607-3160775.14275.111.9075.5675.521.92
231392-3139274.63175.03
330571-3057172.67973.06
431962-3196275.98676.39
532348-3234876.90477.35
631671-3167175.29475.73
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%
116.133807338030382103807938026380840.20
216.103829737994381460.57
单位质量响应值RSD%判断
2361.072369.320.25数据可信
供试品溶液-2025030321批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14093-40939.7158.6318.469.718.6318.45
23730-37308.8538.85
34370-437010.37210.37
43914-39149.2909.29
53168-31687.5197.52
62541-25416.0316.03
10min14650-465011.03711.279.5711.0511.299.55
25232-523212.41812.43
34331-433110.28010.30
45051-505111.98912.00
55112-511212.13312.15
64123-41239.7869.80
15min17791-779118.49219.5710.2218.5319.6110.21
29277-927722.01922.05
37537-753717.88917.92
48799-879920.88420.92
58871-887121.05521.09
67206-720617.10317.13
20min111265-1126526.73728.047.4926.8028.117.49
212772-1277230.31430.39
311010-1101026.13226.20
412435-1243529.51429.58
512610-1261029.93030.00
610801-1080125.63625.69
30min117484-1748441.49842.424.0141.6142.544.02
218706-1870644.39944.52
316950-1695040.23140.34
418383-1838343.63243.75
518411-1841143.69843.82
617309-1730941.08341.18
45min124099-2409957.19957.822.4057.3858.002.41
224864-2486459.01559.21
323630-2363056.08656.26
425071-2507159.50659.70
524646-2464658.49758.69
623851-2385156.61056.78
60min128602-2860267.88767.741.5668.1668.021.57
228772-2877268.29068.59
327830-2783066.05466.32
429003-2900368.83869.13
528843-2884368.45968.75
628204-2820466.94267.20
极限130842-3084273.20373.041.2973.5973.431.30
231063-3106373.72874.14
330112-3011271.47171.85
431107-3110773.83274.24
531020-3102073.62674.03
630491-3049172.37072.74
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%
116.133806237918380893817837888380270.32
216.103855438043382980.95
单位质量响应值RSD%判断
2357.532378.760.64数据可信
供试品溶液-2025030422批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13485-34858.2618.6012.918.268.6012.89
23749-37498.8878.89
32951-29516.9967.00
44182-41829.9149.91
54079-40799.6709.67
63324-33247.8807.88
10min17265-726517.22215.747.8617.2415.757.87
26926-692616.41916.43
35733-573313.59013.60
46845-684516.22716.24
56523-652315.46315.48
66547-654715.52015.53
15min111361-1136126.93225.025.5526.9725.065.55
210095-1009523.93123.97
39748-974823.10823.14
410931-1093125.91325.96
510437-1043724.74224.78
610767-1076725.52425.56
20min114953-1495335.44733.703.7535.5333.783.75
213828-1382832.78032.86
313544-1354432.10732.18
414659-1465934.75034.84
513969-1396933.11533.20
614333-1433333.97734.06
30min120470-2047048.52646.962.5248.6747.102.52
219375-1937545.93046.07
319223-1922345.57045.70
420229-2022947.95448.10
519568-1956846.38746.53
619994-1999447.39747.54
45min126092-2609261.85361.281.2562.0861.501.25
225593-2559360.67060.88
325605-2560560.69960.90
426229-2622962.17862.40
525492-2549260.43160.65
626092-2609261.85362.07
60min132914-3291478.02577.411.2078.3677.731.21
232510-3251077.06777.38
332421-3242176.85677.16
433143-3314378.56878.90
532074-3207476.03476.35
632870-3287077.92178.24
极限135124-3512483.26482.411.2283.7282.851.22
234611-3461182.04882.49
334578-3457881.97082.40
435175-3517583.38583.84
534078-3407880.78481.23
635008-3500882.98983.44
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%
116.133822837837380073814237866380160.45
216.103860238486385440.22
单位质量响应值RSD%判断
2356.852394.041.11数据可信
供试品溶液-2025030422批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12415-24155.7086.5110.365.716.5110.37
22493-24935.8925.89
33184-31847.5257.53
42699-26996.3796.38
52798-27986.6136.61
62938-29386.9446.94
10min14229-42299.99511.8015.1910.0011.8115.18
24509-450910.65710.67
36004-600414.19014.20
45386-538612.72912.74
54255-425510.05610.07
65573-557313.17113.18
15min17647-764718.07319.9411.1918.1019.9811.19
27873-787318.60718.63
39471-947122.38422.42
49087-908721.47621.51
57286-728617.22017.25
69270-927021.90921.94
20min111336-1133626.79128.338.7226.8528.408.72
211684-1168427.61427.67
312996-1299630.71530.79
412928-1292830.55430.62
510364-1036424.49424.55
612623-1262329.83329.90
30min119846-1984646.90445.0410.5947.0045.1510.58
217849-1784942.18442.29
321114-2111449.90150.03
421303-2130350.34750.47
516264-1626438.43838.54
617971-1797142.47242.59
45min126992-2699263.79363.963.1063.9764.153.11
227201-2720164.28664.46
327472-2747264.92765.13
428162-2816266.55866.76
525615-2561560.53860.70
626940-2694063.67063.86
60min131575-3157574.62474.442.9174.9174.742.92
231710-3171074.94375.23
331632-3163274.75975.07
432824-3282477.57677.89
529978-2997870.85071.11
631274-3127473.91374.21
极限134248-3424880.94180.172.5081.3580.592.51
234088-3408880.56380.97
333960-3396080.26180.70
435099-3509982.95383.40
532519-3251976.85577.24
633617-3361779.45079.87
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