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4000
标示量(mg)4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%
115.983720137069371653714736875370910.36
216.073718636733369600.87
单位质量响应值RSD%判断
2321.092299.940.65数据可信
供试品溶液-KC031批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12373-23735.7666.6213.515.776.6213.50
23089-30897.5057.51
32540-25406.1716.17
43171-31717.7057.70
52314-23145.6225.62
62858-28586.9446.94
10min110037-1003724.38726.1813.6124.4026.1813.61
213051-1305131.71031.72
39892-989224.03524.04
412191-1219129.62129.63
59546-954623.19423.20
69922-992224.10824.12
15min118727-1872745.50149.5612.3245.5549.6112.32
223567-2356757.26157.33
318653-1865345.32145.37
423434-2343456.93857.00
517875-1787543.43143.48
620126-2012648.90048.95
20min126719-2671964.91969.6110.0565.0569.7510.05
231908-3190877.52777.69
326572-2657264.56264.69
432474-3247478.90279.06
525812-2581262.71662.84
628404-2840469.01369.15
30min136595-3659588.91592.265.1089.1592.515.11
239223-3922395.30095.59
336060-3606087.61587.85
440976-4097699.56099.85
536463-3646388.59488.82
638504-3850493.55393.80
45min140620-4062098.695100.062.6899.08100.472.69
241043-4104399.722100.17
339508-3950895.99396.37
442274-42274102.713103.17
541142-4114299.963100.34
642508-42508103.282103.69
60min141033-4103399.698100.822.26100.25101.402.28
241632-41632101.154101.77
340147-4014797.54598.08
442532-42532103.340103.97
541092-4109299.841100.38
642544-42544103.369103.95
极限141205-41205100.116100.641.28100.83101.391.30
241068-4106899.783100.57
340974-4097499.555100.26
442113-42113102.322103.12
541088-4108899.832100.54
642085-42085102.254103.00
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4000
标示量(mg)4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%
115.983695537218369073714137127370700.36
216.073729537120372080.34
单位质量响应值RSD%判断
2319.772315.370.14数据可信
供试品溶液-KC031批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12790-27906.7586.408.886.766.408.89
22336-23365.6585.66
32706-27066.5556.55
42893-28937.0087.01
52367-23675.7335.73
62771-27716.7126.71
10min110955-1095526.53624.2510.2926.5524.2610.29
29654-965423.38423.39
311608-1160828.11828.13
49567-956723.17423.19
59130-913022.11522.12
69144-914422.14922.16
15min120500-2050049.65646.888.8249.7146.938.81
219453-1945347.12047.17
322065-2206553.44753.50
418618-1861845.09845.15
517991-1799143.57943.63
617488-1748842.36042.41
20min129384-2938471.17667.447.9071.3167.577.90
227968-2796867.74667.87
331298-3129875.81275.96
426950-2695065.28065.41
525973-2597362.91363.03
625485-2548561.73161.85
30min138982-3898294.42490.385.8394.6890.625.83
237096-3709689.85690.10
340264-4026497.53097.80
437737-3773791.40991.64
534536-3453683.65583.88
635268-3526885.42885.65
45min141874-41874101.43099.263.87101.8499.663.88
240676-4067698.52898.92
343143-43143104.503104.94
441131-4113199.630100.02
538355-3835592.90693.27
640702-4070298.59198.95
60min141951-41951101.616100.113.89102.20100.673.90
241210-4121099.821100.38
343273-43273104.818105.43
441834-41834101.333101.89
538424-3842493.07393.59
641276-4127699.981100.51
极限141917-41917101.534100.861.83102.29101.581.86
241672-41672100.940101.66
342921-42921103.966104.75
441279-4127999.988100.71
540649-4064998.46299.14
641389-41389100.255100.95
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