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%
114.461629521626451625321624191621841625460.18
214.321609041608871608960.01
单位质量响应值RSD%判断
11241.0811235.750.04数据可信
加速6月-供试品溶液-bc1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%
5min156426-5642635.08034.796.4835.0834.796.49
259319-5931936.87836.88
352114-5211432.39932.40
10min162641-6264138.94436.0310.4439.3336.4210.38
260097-6009737.36237.77
351128-5112831.78632.15
15min183222-8322251.73950.004.5352.5650.784.57
281723-8172350.80751.63
376311-7631147.44248.16
20min191450-9145056.85452.8310.3258.2554.1710.22
288464-8846454.99856.39
375005-7500546.63047.87
30min199767-9976762.02559.824.8964.0561.744.98
297984-9798460.91662.92
390887-9088756.50458.26
45min1110292-11029268.56863.0910.0771.2965.689.95
2103863-10386364.57167.25
390279-9027956.12658.51
60min1111919-11191969.58067.114.7473.0670.414.87
2109743-10974368.22771.62
3102181-10218163.52666.54
90min1121792-12179275.71870.859.7579.9774.899.60
2118853-11885373.89078.04
3101255-10125562.95066.67
极限1129805-12980580.69978.344.9285.7983.175.06
2129376-12937680.43385.41
3118871-11887173.90278.32
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%
114.461608301608651605181613761612981609770.23
214.321595021595701595360.04
单位质量响应值RSD%判断
11132.5711140.780.06数据可信
加速6月-供试品溶液-023200批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159256-5925637.17636.841.4137.1836.841.41
259126-5912637.09437.09
357765-5776536.24036.24
10min182014-8201451.45451.882.0151.8752.292.00
284584-8458453.06653.48
381481-8148151.11951.52
15min197128-9712860.93661.701.0861.9262.691.07
299033-9903362.13163.13
398884-9888462.03763.01
20min1109997-10999769.00969.691.5270.6771.361.51
2113017-11301770.90472.60
3110226-11022669.15370.81
30min1131642-13164282.58980.352.5785.0282.802.49
2127432-12743279.94882.43
3125164-12516478.52580.95
45min1140855-14085588.36988.411.2691.7291.751.25
2142724-14272489.54292.91
3139185-13918587.32190.62
60min1144202-14420290.46990.600.6794.8094.920.68
2145449-14544991.25195.61
3143569-14356990.07294.34
90min1143013-14301389.72390.811.0595.0696.140.99
2145762-14576291.44896.82
3145470-14547091.26496.54
极限1141161-14116188.56188.800.2694.8995.140.28
2141884-14188489.01595.41
3141586-14158688.82895.11
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