他克莫司缓释颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
114.861567451573261571361569881567201569830.17
214.821560761560761560760.00
单位质量响应值RSD%判断
10564.1310531.440.22数据可信
供试品溶液-2025052121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%
5min165011-6501143.44541.753.5143.4541.753.51
258645-5864539.19139.19
363567-6356742.48042.48
461862-6186241.34141.34
563577-6357742.48742.49
662179-6217941.55341.55
10min190847-9084760.71161.003.5561.1961.463.54
285879-8587957.39157.83
395762-9576263.99564.47
491084-9108460.86961.33
591123-9112360.89561.37
692953-9295362.11862.58
15min1106745-10674571.33571.884.1672.4973.024.14
2101404-10140467.76668.84
3113923-11392376.13277.31
4104792-10479270.03071.17
5107303-10730371.70872.86
6111189-11118974.30575.46
20min1115149-11514976.95178.213.3678.9080.153.36
2110697-11069773.97675.80
3122457-12245781.83583.86
4117418-11741878.46780.38
5117539-11753978.54880.49
6118915-11891579.46881.45
30min1125000-12500083.53485.622.3786.3488.432.39
2124227-12422783.01885.67
3132300-13230088.41391.35
4128804-12880486.07688.86
5128616-12861685.95188.77
6129786-12978686.73389.59
45min1135571-13557190.59992.142.4094.3395.902.41
2133635-13363589.30592.88
3143302-14330295.76599.69
4139165-13916593.00096.74
5137846-13784692.11995.89
6137763-13776392.06395.89
60min1137218-13721891.69993.602.1996.4498.392.22
2136214-13621491.02895.59
3144597-14459796.630101.62
4139752-13975293.39398.17
5141113-14111394.30299.10
6141523-14152394.57699.42
90min1138386-13838692.48094.602.1798.24100.422.19
2137809-13780992.09497.67
3146122-14612297.650103.71
4141988-14198894.887100.70
5142541-14254195.257101.10
6142501-14250195.230101.13
极限1135279-13527990.40392.972.2197.1999.842.23
2135670-13567090.66597.26
3142738-14273895.388102.53
4138975-13897592.87399.74
5140621-14062193.973100.88
6141392-14139294.489101.44
他克莫司缓释颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
114.861572691569981570531570771573921571580.11
214.821568771564631566700.19
单位质量响应值RSD%判断
10575.9110571.520.03数据可信
供试品溶液-2025052121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%
5min167286-6728644.85544.605.0244.8644.605.02
264332-6433242.88642.89
365188-6518843.45743.46
464980-6498043.31843.32
566179-6617944.11744.12
673419-7341948.94448.94
10min198528-9852865.68265.052.6766.1865.552.68
294744-9474463.16063.64
395502-9550263.66564.15
495718-9571863.80964.29
5100619-10061967.07667.57
6100372-10037266.91167.46
15min1112806-11280675.20074.883.6676.4376.103.65
2111521-11152174.34475.52
3110969-11096973.97675.17
4106795-10679571.19372.38
5112362-11236274.90476.14
6119468-11946879.64180.93
20min1122286-12228681.52081.293.3783.5883.343.36
2117768-11776878.50880.51
3122863-12286381.90583.92
4116919-11691977.94279.92
5123716-12371682.47384.54
6128065-12806585.37287.54
30min1132808-13280888.53489.283.7491.5092.243.72
2129289-12928986.18889.07
3133479-13347988.98291.90
4129744-12974486.49289.34
5135237-13523790.15493.14
6143038-14303895.35498.47
45min1138708-13870892.46794.053.2696.4298.003.26
2136057-13605790.70094.53
3142534-14253495.01898.93
4137676-13767691.78095.59
5142836-14283695.21999.21
6148680-14868099.115103.30
60min1142176-14217694.77995.143.5499.76100.133.52
2137972-13797291.97796.82
3143882-14388295.917100.88
4139594-13959493.05897.89
5140508-14050893.66798.71
6152136-152136101.419106.70
90min1142753-14275395.16495.333.60101.20101.383.57
2137304-13730491.53297.40
3144686-14468696.453102.49
4139689-13968993.12198.98
5141452-14145294.297100.38
6152116-152116101.406107.81
极限1138122-13812292.07793.573.7299.17100.683.67
2135748-13574890.49497.38
3143585-14358595.719102.82
4137619-13761991.74298.64
5137596-13759691.72698.86
6149534-14953499.684107.22
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