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D230603FK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%
114.061548021549191543121537551540841543740.32
213.721495641492901494270.13
单位质量响应值RSD%判断
10979.6610891.180.58数据可信
供试品溶液-2025032622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%
5min155384-5538435.38737.785.2835.3937.785.28
256282-5628235.96035.96
360621-6062138.73338.73
458128-5812837.14037.14
563709-6370940.70640.71
660666-6066638.76138.76
10min182247-8224752.55053.922.6552.9454.342.66
282839-8283952.92953.33
387161-8716155.69056.12
482417-8241752.65953.07
586865-8686555.50155.95
684789-8478954.17454.61
15min1101303-10130364.72662.774.2765.7063.794.23
293142-9314259.51160.50
3103672-10367266.23967.29
493579-9357959.79160.79
598387-9838762.86363.93
699414-9941463.51964.55
20min1112943-11294372.16370.155.2173.8671.875.16
2103105-10310565.87767.53
3117998-11799875.39377.18
4103684-10368466.24767.91
5111777-11177771.41873.19
6109233-10923369.79371.53
30min1115443-11544373.76075.673.8476.2678.173.78
2119984-11998476.66279.04
3126260-12626080.67283.29
4113248-11324872.35874.76
5116624-11662474.51577.08
6119069-11906976.07778.59
45min1133064-13306485.01981.304.2088.3484.644.15
2122467-12246778.24881.48
3133228-13322885.12488.64
4120398-12039876.92680.13
5128448-12844882.07085.46
6125848-12584880.40883.77
60min1128714-12871482.24084.204.2586.5088.434.19
2130295-13029583.25087.35
3141715-14171590.54695.01
4126609-12660980.89584.95
5134760-13476086.10390.40
6128559-12855982.14186.39
90min1136520-13652087.22788.014.4692.4093.194.38
2139240-13924088.96593.99
3146825-14682593.81199.28
4129211-12921182.55787.51
5141172-14117290.19995.46
6133542-13354285.32490.49
极限1132107-13210784.40786.993.7890.5593.143.73
2137268-13726887.70593.72
3145051-14505192.67899.19
4131326-13132683.90889.78
5137921-13792188.12294.38
6133192-13319285.10191.21
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