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%
114.01 1622401623601621931626361627961624450.17
213.991624111624461624280.02
单位质量响应值RSD%判断
11594.9311610.290.10数据可信
供试品溶液-24051501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133306-3330620.79224.1320.2420.7924.1320.24
236767-3676722.95322.95
331148-3114819.44519.44
433736-3373621.06021.06
548776-4877630.45030.45
648174-4817430.07430.07
10min152399-5239932.71140.0115.6432.9440.2715.62
276039-7603947.46947.72
360351-6035137.67637.89
454197-5419733.83434.07
567490-6749042.13242.47
674036-7403646.21946.55
15min160793-6079337.95148.2313.5838.5548.9413.57
281875-8187551.11251.89
377398-7739848.31848.95
473616-7361645.95746.57
576949-7694948.03748.84
692891-9289157.98958.84
20min171620-7162044.71053.2110.6845.7354.4610.71
294334-9433458.89060.24
389229-8922955.70356.87
477992-7799248.68849.81
584270-8427052.60853.95
693997-9399758.68060.17
30min187035-8703554.33465.1112.0555.8566.9512.03
2122278-12227876.33578.34
3100747-10074762.89464.68
497849-9784961.08562.75
5102989-10298964.29366.22
6114861-11486171.70573.85
45min1100320-10032062.62778.8813.2064.7481.4413.16
2145417-14541790.78093.63
3120130-12013074.99477.48
4118647-11864774.06876.41
5132745-13274582.86985.51
6140851-14085187.93090.87
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%
114.01 1629451632391631771630391627221630240.13
213.991621761620701621230.05
单位质量响应值RSD%判断
11636.2611588.490.30数据可信
供试品溶液-24051501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%
5min153896-5389633.61832.965.6833.6232.965.69
251470-5147032.10432.10
353835-5383533.58033.58
456325-5632535.13335.13
547590-4759029.68429.68
653981-5398133.67133.67
10min185272-8527253.18851.0211.7553.5651.3811.67
296099-9609959.94260.30
373882-7388246.08446.46
487626-8762654.65755.05
577427-7742748.29548.62
670422-7042243.92644.30
15min196223-9622360.01959.429.4260.9860.369.37
298670-9867061.54662.57
391760-9176057.23558.12
4110509-11050968.93069.93
589984-8998456.12856.99
684451-8445152.67653.54
20min1104452-10445265.15265.207.2166.7866.807.20
2105151-10515165.58867.29
398320-9832061.32762.85
4118622-11862273.99175.75
5102652-10265264.02965.52
698013-9801361.13662.58
30min1119146-11914674.31778.687.9476.6781.007.89
2127311-12731179.41081.85
3126586-12658678.95881.16
4145038-14503890.46893.05
5120441-12044175.12577.33
6118315-11831573.79975.93
45min1142416-14241688.83289.719.3292.0192.909.25
2149372-14937293.17196.49
3142269-14226988.74091.82
4166828-166828104.059107.65
5132774-13277482.81885.85
6129311-12931180.65883.60
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