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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
113.952986330102296162976929585297870.71
213.712888128868288740.04
单位质量响应值RSD%判断
2135.272106.050.98数据可信
供试品溶液-123640批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112052-1205239.70935.308.0339.7135.308.04
210128-1012833.37033.37
311143-1114336.71436.71
411080-1108036.50736.51
59783-978332.23332.23
610096-1009633.26533.26
10min117964-1796459.18856.166.6359.6356.556.62
215871-1587152.29252.66
316160-1616053.24453.65
418769-1876961.84162.25
517086-1708656.29556.65
616417-1641754.09154.46
15min119864-1986465.44864.366.2766.5565.386.25
218761-1876161.81462.77
318868-1886862.16763.17
421811-2181171.86372.96
519425-1942564.00264.99
618469-1846960.85261.82
20min123838-2383878.54272.725.3980.3774.465.34
221058-2105869.38271.02
321245-2124569.99971.69
422049-2204972.64874.54
523177-2317776.36478.06
621063-2106369.39971.05
30min124318-2431880.12477.957.6282.8280.497.41
223287-2328776.72779.14
320378-2037867.14269.61
424148-2414879.56382.26
524044-2404479.22181.76
625782-2578284.94787.37
45min127474-2747490.52285.605.4394.1189.015.35
225016-2501682.42385.69
325660-2566084.54587.76
426979-2697988.89192.47
526956-2695688.81592.24
623805-2380578.43381.80
60min129449-2944997.02992.745.66101.6297.105.56
225673-2567384.58888.77
326944-2694488.77692.93
428656-2865694.41798.99
529921-2992198.585102.99
628237-2823793.03697.27
90min128563-2856394.11091.596.1799.7896.985.98
226490-2649087.28092.40
326504-2650487.32692.47
430481-30481100.430106.05
526114-2611486.04191.55
628635-2863594.34799.61
极限128736-2873694.68091.545.09101.4097.945.01
225841-2584185.14291.23
326097-2609785.98592.10
428849-2884995.052101.79
528712-2871294.601101.06
628462-2846293.777100.09
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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
113.953076130482304913099230751306950.70
213.713009830362302300.62
单位质量响应值RSD%判断
2200.362204.960.15数据可信
供试品溶液-123640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%
5min19926-992631.48636.278.0331.4936.278.02
211940-1194037.87437.87
311087-1108735.16835.17
411733-1173337.21737.22
511285-1128535.79635.80
612636-1263640.08240.08
10min117930-1793056.87458.423.1557.2258.833.14
218992-1899260.24360.66
319265-1926561.10961.50
418147-1814757.56357.98
517866-1786656.67157.07
618312-1831258.08658.53
15min120846-2084666.12465.514.2167.1166.574.13
221407-2140767.90468.99
319766-1976662.69863.77
421886-2188669.42370.48
520100-2010063.75864.79
619914-1991463.16864.26
20min121990-2199069.75370.303.4171.4772.083.34
223436-2343674.34076.18
321911-2191169.50271.27
421535-2153568.31070.13
522647-2264771.83773.57
621457-2145768.06269.85
30min124965-2496579.19078.062.7081.6880.622.64
225219-2521979.99582.67
325264-2526480.13882.68
424236-2423676.87779.46
523565-2356574.74977.28
624400-2440077.39779.95
45min127962-2796288.69685.672.9392.0789.102.82
227290-2729086.56590.12
326626-2662684.45887.89
427248-2724886.43189.87
527273-2727386.51189.88
625648-2564881.35684.76
60min127324-2732486.67287.983.0791.0392.372.94
228061-2806189.01093.53
326459-2645983.92988.30
428556-2855690.58094.98
528679-2867990.97095.30
627348-2734886.74991.06
90min126033-2603382.57786.934.8387.9092.284.55
226712-2671284.73190.24
326781-2678184.95090.25
428455-2845590.26095.66
529553-2955393.74399.08
626893-2689385.30590.58
极限126291-2629183.39686.522.0489.6392.841.98
227819-2781988.24394.69
327310-2731086.62892.87
427758-2775888.04994.46
527368-2736886.81293.19
627113-2711386.00392.23
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