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%
114.261547351539171541841536971533011539670.35
214.001538561537541538050.05
单位质量响应值RSD%判断
10797.1210986.071.23数据可信
供试品溶液-023200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%
5min159036-5903637.87436.193.5037.8736.183.51
258023-5802337.22437.22
356764-5676436.41636.42
453535-5353534.34534.34
555761-5576135.77335.77
655327-5532735.49535.49
10min186356-8635655.40152.803.4455.8253.203.43
284962-8496254.50754.92
378678-7867850.47550.88
481058-8105852.00252.38
581478-8147852.27152.67
681309-8130952.16352.56
15min199032-9903263.53361.532.3864.5762.522.39
298180-9818062.98664.01
396001-9600161.58962.55
493585-9358560.03961.00
594929-9492960.90161.88
693741-9374160.13961.11
20min1109758-10975870.41468.312.7372.1669.982.73
2110535-11053570.91372.63
3105359-10535967.59269.24
4105102-10510267.42769.05
5104278-10427866.89968.55
6103867-10386766.63568.28
30min1120451-12045177.27478.471.2779.8080.901.24
2124612-12461279.94482.45
3123727-12372779.37681.78
4121589-12158978.00480.38
5121973-12197378.25180.65
6121528-12152877.96580.35
45min1127973-12797382.10085.262.0185.4888.561.88
2132491-13249184.99888.39
3133798-13379885.83789.12
4135898-13589887.18490.43
5133220-13322085.46688.73
6133987-13398785.95889.21
60min1140651-14065190.23388.881.4294.5393.131.41
2140170-14017089.92594.26
3140124-14012489.89594.13
4137252-13725288.05392.26
5136592-13659287.62991.85
6136473-13647387.55391.76
90min1147688-14768894.74891.681.92100.0596.921.85
2143022-14302291.75497.09
3139173-13917389.28594.52
4142384-14238491.34596.53
5142206-14220691.23196.42
6142938-14293891.70196.88
极限1144758-14475892.86890.561.4199.2296.811.39
2141918-14191891.04697.40
3140779-14077990.31596.54
4140393-14039390.06896.27
5139895-13989589.74895.95
6139176-13917689.28795.48
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