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%
116.137564776149764467572276305760540.47
216.107574176396760680.61
单位质量响应值RSD%判断
4715.074724.720.15数据可信
供试品溶液-2025022821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%
5min13058-30583.6374.2124.743.644.2124.67
23465-34654.1214.12
32463-24632.9292.93
43065-30653.6453.65
54586-45865.4555.45
64594-45945.4645.46
10min17923-79239.4239.8314.879.439.8414.90
27771-77719.2439.25
36558-65587.8007.80
47926-79269.4279.43
59717-971711.55711.57
69696-969611.53211.54
15min115892-1589218.90218.4210.7718.9218.4510.78
214686-1468617.46717.49
312940-1294015.39115.41
414913-1491317.73717.76
517074-1707420.30820.34
617428-1742820.72920.76
20min123453-2345327.89526.697.9227.9526.757.93
221717-2171725.83025.88
319535-1953523.23523.28
421820-2182025.95226.00
523825-2382528.33728.40
624310-2431028.91428.98
30min134678-3467841.24539.924.3941.3540.024.40
233448-3344839.78239.88
331097-3109736.98637.07
432762-3276238.96739.06
534391-3439140.90441.01
635032-3503241.66641.78
45min147027-4702755.93354.212.7556.1054.382.76
245727-4572754.38754.55
343663-4366351.93252.08
444623-4462353.07453.23
545825-4582554.50354.68
646607-4660755.43455.61
60min155855-5585566.43364.222.3466.6964.472.35
254136-5413664.38864.64
352251-5225162.14662.38
453145-5314563.21063.46
553756-5375663.93664.20
654814-5481465.19565.47
极限160201-6020171.60270.011.9371.9770.371.94
259612-5961270.90171.26
357245-5724568.08668.42
457761-5776168.70069.05
559018-5901870.19570.57
659349-5934970.58970.97
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%
116.137577876453762147622276423762180.36
216.107721977511773650.27
单位质量响应值RSD%判断
4725.234805.281.19数据可信
供试品溶液-2025022821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%
5min13328-33283.9214.2219.003.924.2219.08
24554-45545.3655.37
34227-42274.9804.98
43533-35334.1624.16
52864-28643.3743.37
62974-29743.5043.50
10min18590-859010.1209.8318.2910.139.8418.28
210646-1064612.54212.55
38014-80149.4429.45
49273-927310.92510.93
56342-63427.4727.48
67201-72018.4848.49
15min116180-1618019.06218.3014.2619.0918.3214.27
218445-1844521.73121.76
315407-1540718.15218.18
416969-1696919.99220.02
512186-1218614.35714.37
614007-1400716.50216.52
20min122819-2281926.88426.3910.6526.9426.4510.66
225610-2561030.17230.24
322542-2254226.55826.61
423455-2345527.63327.69
518376-1837621.65021.69
621614-2161425.46425.51
30min133337-3333739.27639.146.2839.3839.246.29
235976-3597642.38542.50
333370-3337039.31539.41
434026-3402640.08740.19
529560-2956034.82634.90
633060-3306038.94939.04
45min145292-4529253.36053.253.5953.5353.423.61
247193-4719355.60055.79
345676-4567653.81353.98
445449-4544953.54553.72
542230-4223049.75349.89
645343-4534353.42053.58
60min152885-5288562.30663.082.7962.5663.342.81
255697-5569765.61965.90
353793-5379363.37663.63
453393-5339362.90563.17
551217-5121760.34160.56
654284-5428463.95464.20
极限156922-5692267.06268.472.7967.4268.822.81
260627-6062771.42771.82
358240-5824068.61568.97
457794-5779468.09068.45
556032-5603266.01466.33
659068-5906869.59069.94
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%
116.137716577018762607689876918768520.46
216.107734477856776000.47
单位质量响应值RSD%判断
4764.544819.880.82数据可信
供试品溶液-2025030121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%
5min12558-25582.9973.0618.333.003.0618.35
22221-22212.6022.60
33289-32893.8533.85
43018-30183.5363.54
52580-25803.0223.02
62008-20082.3522.35
10min18028-80289.4058.1015.109.418.1115.08
25781-57816.7726.78
37647-76478.9588.96
47715-77159.0389.04
56721-67217.8737.88
65608-56086.5706.57
15min115416-1541618.05915.8112.7718.0815.8312.76
211712-1171213.72013.74
314567-1456717.06517.09
415008-1500817.58117.60
512817-1281715.01515.03
611475-1147513.44313.46
20min122105-2210525.89523.589.2525.9523.629.26
218476-1847621.64421.68
321321-2132124.97725.03
421836-2183625.58025.63
519236-1923622.53422.58
617775-1777520.82320.86
30min132786-3278638.40836.325.8038.5036.415.81
229181-2918134.18534.26
331975-3197537.45837.55
432868-3286838.50438.60
530439-3043935.65835.74
628792-2879233.72933.80
45min144461-4446152.08550.213.8852.2450.353.90
241122-4112248.17348.30
343913-4391351.44351.60
444632-4463252.28552.44
541940-4194049.13249.27
641097-4109748.14448.27
60min151959-5195960.86959.823.1461.1160.053.16
249069-4906957.48357.69
352106-5210661.04161.28
453215-5321562.34062.58
550320-5032058.94859.17
649726-4972658.25358.46
极限157039-5703966.82065.772.7167.1766.102.72
254281-5428163.58963.90
356945-5694566.70967.05
458289-5828968.28468.63
555154-5515464.61164.93
655140-5514064.59564.90
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%
116.137723977319768467746877288772320.31
216.107858378289784360.27
单位质量响应值RSD%判断
4788.104871.801.23数据可信
供试品溶液-2025030121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%
5min12007-20072.3333.1018.662.333.1018.66
22235-22352.5982.60
33359-33593.9043.90
42752-27523.1993.20
52625-26253.0513.05
63025-30253.5163.52
10min15977-59776.9477.8314.466.957.8314.44
25990-59906.9636.97
38505-85059.8869.89
47057-70578.2038.21
56739-67397.8337.84
66126-61267.1217.13
15min111520-1152013.39014.9013.4213.4114.9213.41
211583-1158313.46413.48
315875-1587518.45318.48
413727-1372715.95615.97
512558-1255814.59714.62
611665-1166513.55913.58
20min117871-1787120.77322.5710.0520.8122.6110.05
217911-1791120.81920.86
322444-2244426.08826.14
421210-2121024.65424.70
518992-1899222.07622.12
618077-1807721.01221.05
30min128709-2870933.37035.135.9533.4435.215.97
228822-2882233.50233.57
332913-3291338.25738.35
431936-3193637.12137.21
530047-3004734.92635.00
628923-2892333.61933.69
45min140983-4098347.63749.143.8647.7749.283.87
240837-4083747.46847.60
344456-4445651.67451.84
444016-4401651.16351.31
542403-4240349.28849.43
640960-4096047.61147.74
60min152229-5222960.70960.134.3260.9260.354.32
249861-4986157.95758.16
355664-5566464.70264.95
452364-5236460.86661.10
550368-5036858.54658.77
649888-4988857.98858.20
极限157881-5788167.27968.582.4367.5968.902.44
258046-5804667.47167.78
360441-6044170.25570.61
461159-6115971.08971.42
558498-5849867.99668.31
657963-5796367.37467.68
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