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%
113.991556001553631556231542781544191550570.43
214.111568451568781568620.02
单位质量响应值RSD%判断
11083.4211117.080.22数据可信
供试品溶液-第1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%
5min156548-5654836.89934.186.7036.9034.186.71
250686-5068633.07433.07
349977-4997732.61132.61
455087-5508735.94635.95
554494-5449435.55935.56
647511-4751131.00231.00
10min183980-8398054.79949.186.7555.2149.566.74
271494-7149446.65247.02
370527-7052746.02146.38
478437-7843751.18251.58
575064-7506448.98149.38
672731-7273147.45947.80
15min199213-9921364.73958.536.3165.7659.466.32
284972-8497255.44756.33
385584-8558455.84656.72
493196-9319660.81361.78
589791-8979158.59159.53
685446-8544655.75656.63
20min1111306-11130672.63065.866.7274.3767.436.71
294133-9413361.42462.93
395485-9548562.30763.80
4106080-10608069.22070.86
5101931-10193166.51368.10
696615-9661563.04464.54
30min1127289-12728983.06075.706.7485.6078.006.72
2107393-10739370.07772.26
3110815-11081572.31074.50
4120418-12041878.57680.99
5120320-12032078.51280.84
6109793-10979371.64373.83
45min1141104-14110492.07483.706.4695.5486.856.46
2118895-11889577.58280.55
3122907-12290780.20083.19
4134179-13417987.55590.84
5129328-12932884.39087.59
6123235-12323580.41483.40
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%
113.991582891581351582161566991564221575520.58
214.111558581557711558140.04
单位质量响应值RSD%判断
11261.7611042.811.39数据可信
供试品溶液-第2批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159488-5948838.64038.992.0538.6438.992.05
257782-5778237.53237.53
360469-6046939.27739.28
460509-6050939.30339.30
560759-6075939.46639.47
661127-6112739.70539.70
10min188947-8894757.77557.153.6558.2057.583.63
281761-8176153.10753.52
389205-8920557.94358.38
487984-8798457.14957.59
589055-8905557.84558.28
690988-9098859.10159.54
15min1104209-10420967.68866.572.7568.7667.642.74
298752-9875264.14465.15
3101568-10156865.97367.05
4101989-10198966.24667.32
5101438-10143865.88866.97
6106996-10699669.49970.60
20min1112918-11291873.34573.383.6475.1775.193.61
2105646-10564668.62270.34
3116361-11636175.58277.39
4113784-11378473.90875.72
5111978-11197872.73574.55
6117135-11713576.08477.95
30min1124714-12471481.00782.413.7283.6585.033.68
2119479-11947977.60780.09
3131552-13155285.44988.10
4126956-12695682.46485.09
5126220-12622081.98584.61
6132291-13229185.92988.64
45min1138524-13852489.97790.253.3693.5293.793.35
2132044-13204485.76889.11
3141157-14115791.68895.29
4136961-13696188.96292.51
5138791-13879190.15193.68
6146174-14617494.94698.62
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