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 14.313150131536314023148231432314710.18
2 14.203137831423314000.11
单位质量响应值RSD%判断
2199.232211.270.39数据可信
供试品溶液-24102102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%
5min110307-1030732.91233.042.3232.9133.042.33
210247-1024732.72032.72
310781-1078134.42534.43
410170-1017032.47432.47
510448-1044833.36233.36
610134-1013432.35932.36
10min115659-1565950.00148.187.3350.3748.557.27
217076-1707654.52654.89
314717-1471746.99347.38
414568-1456846.51846.88
514410-1441046.01346.38
614110-1411045.05545.41
15min118166-1816658.00660.907.1858.9361.807.09
220921-2092166.80467.77
318574-1857459.30960.21
417998-1799857.47058.35
518056-1805657.65558.54
620713-2071366.13967.00
20min120620-2062065.84267.496.9867.4169.076.92
224068-2406876.85278.56
320718-2071866.15567.72
420208-2020864.52766.04
520151-2015164.34565.87
621052-2105267.22268.82
30min124206-2420677.29376.737.0679.5979.067.00
226878-2687885.82588.39
324682-2468278.81381.11
422195-2219570.87273.10
522497-2249771.83674.07
623721-2372175.74478.09
45min127137-2713786.65283.666.5889.8186.846.50
228155-2815589.90393.42
325573-2557381.65884.83
424057-2405776.81779.84
524537-2453778.35081.39
627741-2774188.58191.76
60min128874-2887492.19888.117.0496.3292.226.96
230043-3004395.931100.45
327124-2712486.61190.69
425500-2550081.42585.30
525290-2529080.75484.66
628726-2872691.72695.89
90min128270-2827090.27088.555.6695.4193.645.67
230094-3009496.094101.68
327775-2777588.68993.73
425823-2582382.45687.24
526152-2615283.50788.31
628279-2827990.29995.49
极限128110-2811089.75987.694.9195.9193.764.95
229309-2930993.588100.24
327741-2774188.58194.61
425687-2568782.02287.72
526094-2609483.32289.05
627828-2782888.85895.05
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 14.311536441535971535561537441535401536160.06
2 14.201539821540501540160.04
单位质量响应值RSD%判断
10734.8710846.200.73数据可信
供试品溶液-24102101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%
5min158500-5850038.17639.314.3338.1839.314.33
262010-6201040.46740.47
358272-5827238.02838.03
460244-6024439.31539.31
564508-6450842.09742.10
657867-5786737.76337.76
10min180864-8086452.77154.714.1253.2055.144.10
285057-8505755.50755.96
378416-7841651.17351.60
484951-8495155.43855.87
586408-8640856.38956.86
687278-8727856.95757.38
15min195176-9517662.11164.963.4363.1266.013.42
299518-9951864.94466.01
396436-9643662.93363.92
4100331-10033165.47566.53
5101165-10116566.01967.11
6104668-10466868.30569.36
20min1110970-11097072.41872.791.7774.1274.551.80
2112011-11201173.09774.89
3108551-10855170.83972.53
4110495-11049572.10873.89
5114089-11408974.45376.28
6113091-11309173.80275.61
30min1119466-11946677.96279.852.8180.4782.422.80
2121532-12153279.31081.91
3118181-11818177.12479.60
4123421-12342180.54383.12
5127769-12776983.38186.04
6123762-12376280.76683.40
45min1125180-12518081.69186.403.6485.0689.863.57
2131423-13142385.76589.25
3129891-12989184.76588.10
4134492-13449287.76891.24
5133992-13399287.44291.02
6139417-13941790.98294.51
60min1130262-13026285.00889.884.0989.2994.304.02
2136332-13633288.96993.40
3132639-13263986.55990.84
4139930-13993091.31795.77
5144195-14419594.10098.65
6143012-14301293.32897.87
90min1135293-13529388.29191.803.1993.5197.223.16
2139608-13960891.10796.53
3136306-13630688.95294.19
4144678-14467894.41599.88
5141550-14155092.37497.97
6146551-14655195.638101.21
极限1133440-13344087.08291.733.4293.2998.173.37
2139216-13921690.85197.29
3137564-13756489.77396.00
4144055-14405594.009100.52
5142353-14235392.89899.52
6146764-14676495.777102.42
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