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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
113.88 1565811565591567381573381572611568950.24
213.861572091572541572320.03
单位质量响应值RSD%判断
11303.6711344.300.26数据可信
供试品溶液-js1y批-含0.005%羟丙基纤维素的pH4.5溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min156153-5615335.91736.302.6535.9236.302.66
258454-5845437.38937.39
355630-5563035.58335.58
10min156500-5650036.13938.308.3636.5438.708.30
265625-6562541.97642.39
357516-5751636.78937.18
15min186010-8601055.01553.632.6455.8254.462.53
281598-8159852.19353.07
383910-8391053.67254.48
20min186369-8636955.24556.395.1256.6657.825.05
293297-9329759.67661.14
384831-8483154.26155.66
30min1102468-10246865.54264.012.1667.5766.072.04
298279-9827962.86364.99
399487-9948763.63565.64
45min1103551-10355166.23567.926.0268.9970.685.86
2113471-11347172.58075.40
3101548-10154864.95467.66
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
113.88 1575701569491570261573051568871571470.19
213.861552091547041549560.24
单位质量响应值RSD%判断
11321.8311180.090.90数据可信
供试品溶液-js1y批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min157142-5714236.78937.184.7036.7937.184.69
260707-6070739.08439.08
355387-5538735.65935.66
10min155623-5562335.81138.355.7436.2238.765.69
261545-6154539.62340.06
361537-6153739.61840.01
15min186654-8665455.78953.579.7756.6054.419.64
289036-8903657.32258.20
373925-7392547.59448.43
20min180644-8064451.91954.934.8253.3556.374.73
288349-8834956.88058.39
386989-8698956.00457.37
30min1105571-10557167.96866.785.2969.9768.825.22
2108030-10803069.55171.69
397557-9755762.80864.80
45min199284-9928463.92065.637.2166.6868.427.09
2110248-11024870.97973.90
396298-9629861.99864.68
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
113.88 1552651556681561551559911560391558240.24
213.861564441567981566210.16
单位质量响应值RSD%判断
11226.5111300.220.47数据可信
供试品溶液-js1y批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min162553-6255340.22740.093.5440.2340.093.55
264436-6443641.43841.44
360044-6004438.61338.61
10min189505-8950557.55957.201.9758.0157.651.93
286987-8698755.94056.40
390343-9034358.09858.53
15min1104334-10433467.09568.932.3968.1870.012.35
2109284-10928470.27971.36
3107930-10793069.40870.48
20min1117261-11726175.40975.733.1277.2477.583.03
2114382-11438273.55775.42
3121660-12166078.23780.08
30min1136969-13696988.08286.663.7090.7589.353.61
2129056-12905682.99485.67
3138264-13826488.91591.63
45min1154135-15413599.12294.484.59102.7798.134.44
2140784-14078490.53694.14
3145819-14581993.77497.48
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