坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.101881251884081881691884681882551882850.08
216.171878501880521879510.08
单位质量响应值RSD%判断
11694.7211623.440.44数据可信
供试品溶液-24121201-yd1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%
5min142167-4216720.41719.249.9020.4219.249.90
245579-4557922.06922.07
341331-4133120.01220.01
436216-3621617.53617.54
535539-3553917.20817.21
637570-3757018.19118.19
10min1100872-10087248.84248.346.6449.0748.566.65
2110624-11062453.56453.81
3102687-10268749.72049.94
493630-9363045.33545.53
598747-9874747.81348.00
692484-9248444.78044.98
15min1149220-14922072.25271.783.8473.0272.543.87
2157791-15779176.40277.24
3149287-14928772.28473.06
4141626-14162668.57569.27
5148343-14834371.82772.55
6143261-14326169.36670.07
20min1167513-16751381.10983.131.4982.6884.681.51
2175059-17505984.76386.45
3173117-17311783.82285.40
4170553-17055382.58184.04
5171758-17175883.16484.68
6172175-17217583.36684.84
30min1190267-19026792.12692.510.5794.6094.990.56
2191776-19177692.85795.49
3189443-18944391.72794.24
4190808-19080892.38894.77
5192225-19222593.07495.52
6191874-19187492.90495.30
45min1196037-19603794.92092.583.2498.4296.083.14
2188759-18875991.39695.06
3192174-19217493.05096.58
4179865-17986587.09090.49
5194541-19454194.19697.67
6195849-19584994.82998.26
60min1196282-19628295.03993.871.1699.5998.401.07
2190910-19091092.43897.12
3192343-19234393.13197.69
4193408-19340893.64798.02
5193573-19357393.72798.25
6196688-19668895.23599.72
极限1190735-19073592.35392.291.0097.9697.860.99
2190683-19068392.32898.03
3189518-18951891.76497.36
4187596-18759690.83396.25
5192264-19226493.09398.66
6192834-19283493.36998.91
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.101883681880081883151880421880161881500.10
216.171881591878741880160.11
单位质量响应值RSD%判断
11686.3411627.460.36数据可信
供试品溶液-24121201-yd1批
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
10min12738-27381.3261.219.961.331.219.88
22619-26191.2681.27
32735-27351.3251.32
42434-24341.1791.18
52246-22461.0881.09
62164-21641.0481.05
15min16724-67243.2562.876.873.272.896.87
25689-56892.7552.77
36018-60182.9142.93
45776-57762.7972.81
55742-57422.7812.79
65655-56552.7392.75
20min18316-83164.0273.965.104.084.015.07
28833-88334.2784.32
38375-83754.0564.10
47633-76333.6973.74
57972-79723.8613.90
67973-79733.8613.90
30min19943-99434.8154.652.284.914.742.32
29531-95314.6164.71
39742-97424.7184.81
49472-94724.5874.67
59322-93224.5144.60
69560-95604.6304.71
45min19917-99174.8035.054.304.955.194.20
210846-108465.2535.40
310731-107315.1975.34
410278-102784.9775.11
510868-108685.2635.40
69920-99204.8044.94
60min111492-114925.5655.502.395.775.692.37
211106-111065.3785.58
311769-117695.7005.90
411109-111095.3805.57
511476-114765.5585.75
611156-111565.4035.59
极限111851-118515.7395.573.556.005.823.47
211266-112665.4565.72
311883-118835.7556.02
411033-110335.3435.59
511841-118415.7345.99
611085-110855.3685.62
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