他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 13.951567201574081571171576731568621571560.25
2 14.031563941562571563260.07
单位质量响应值RSD%判断
11265.6611142.270.78数据可信
供试品溶液-24102101批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169993-6999343.99143.615.5943.9943.615.59
269005-6900543.37043.37
375574-7557447.49947.50
469882-6988243.92243.92
568453-6845343.02343.02
663448-6344839.87839.88
10min195110-9511059.77859.062.8460.2759.542.86
292846-9284658.35558.84
398865-9886562.13862.67
491669-9166957.61558.10
592919-9291958.40158.88
692374-9237458.05858.50
15min1108679-10867968.30669.552.5269.4670.692.53
2109559-10955968.85969.99
3115334-11533472.48973.71
4110483-11048369.44070.57
5112265-11226570.56071.69
6107627-10762767.64568.73
20min1116730-11673073.36676.834.6675.2878.744.61
2120042-12004275.44877.34
3132996-13299683.58985.61
4122138-12213876.76578.66
5122606-12260677.05978.97
6118934-11893474.75176.59
30min1127396-12739680.07084.033.6082.8086.803.58
2135031-13503184.86887.60
3141425-14142588.88791.84
4134780-13478084.71187.46
5133462-13346283.88286.65
6130081-13008181.75784.43
45min1138676-13867687.15990.332.8690.7894.032.86
2146954-14695492.36296.04
3149922-14992294.22898.17
4143763-14376390.35794.05
5141225-14122588.76192.46
6141774-14177489.10692.69
60min1142160-14216089.34992.323.1493.9397.023.13
2149307-14930793.84198.54
3154807-15480797.298102.28
4146775-14677592.25096.95
5144405-14440590.76095.45
6143884-14388490.43395.00
90min1143557-14355790.22793.102.9095.8198.842.91
2150171-15017194.384100.13
3155615-15561597.806103.87
4147580-14758092.75698.48
5146674-14667492.18697.88
6145216-14521691.27096.84
极限1140192-14019288.11291.354.1694.6998.124.09
2147295-14729592.57799.37
3156659-15665998.462105.62
4143621-14362190.26797.02
5142830-14283089.77096.49
6141491-14149188.92995.52
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