乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.381716591715441713191714121713991714670.08
215.411710281704721707500.24
单位质量响应值RSD%判断
11148.7011080.470.44数据可信
供试品溶液-25011401批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min128085-2808514.77314.784.2414.7714.784.25
226864-2686414.13114.13
330354-3035415.96715.97
427960-2796014.70714.71
527567-2756714.50114.50
627703-2770314.57214.57
60min150199-5019926.40625.822.4626.4325.842.46
247190-4719024.82324.85
348158-4815825.33225.36
450001-5000126.30126.33
549947-4994726.27326.30
648998-4899825.77425.80
120min182154-8215443.21442.651.6643.2842.711.67
278931-7893141.51941.58
381875-8187543.06843.14
482463-8246343.37743.45
580627-8062742.41142.48
680391-8039142.28742.35
240min1126868-12686866.73566.071.1666.8866.211.16
2123442-12344264.93365.07
3125927-12592766.24066.38
4127291-12729166.95767.10
5124495-12449565.48665.63
6125554-12555466.04366.18
360min1150774-15077479.31079.771.3779.5680.021.36
2153281-15328180.62880.87
3154155-15415581.08881.34
4152844-15284480.39880.65
5148948-14894878.34978.60
6149926-14992678.86479.11
480min1165875-16587587.25387.781.3687.6488.171.35
2166989-16698987.83988.22
3169418-16941889.11789.50
4169398-16939889.10689.49
5163567-16356786.03986.42
6166061-16606187.35187.73
600min1175248-17524892.18392.281.0592.7192.811.05
2177142-17714293.18093.70
3176051-17605192.60693.14
4177209-17720993.21593.75
5172293-17229390.62991.15
6174692-17469291.89192.42
720min1179967-17996794.66695.191.0195.3595.871.01
2182442-18244295.96896.65
3182223-18222395.85296.54
4182962-18296296.24196.93
5178423-17842393.85394.53
6179746-17974694.54995.23
960min1185951-18595197.81398.011.1298.6598.841.12
2187587-18758798.67499.51
3187373-18737398.56199.41
4188745-18874599.283100.13
5182852-18285296.18397.01
6185389-18538997.51898.35
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1189881-18988199.881101.132.19100.88102.132.17
2192884-192884101.460102.46
3190748-190748100.337101.35
4192619-192619101.321102.34
5187545-18754598.65299.64
6199825-199825105.111106.11
1440min1190783-190783100.355100.910.90101.53102.090.89
2192811-192811101.422102.59
3192776-192776101.403102.58
4194040-194040102.068103.25
5189258-18925899.553100.71
6191414-191414100.687101.86
极限1191240-191240100.595100.790.98101.93102.130.97
2192445-192445101.229102.57
3192095-192095101.045102.39
4194432-194432102.274103.63
5188941-18894199.386100.71
6190529-190529100.221101.56
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