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500
标示量(mg)30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%
115.351760241760001758091758461756241758610.10
215.331754951755421755180.02
单位质量响应值RSD%判断
11456.7411449.320.05数据可信
供试品溶液-1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%
30min125335-2533512.93312.891.8412.9312.891.84
224605-2460512.56012.56
325322-2532212.92612.93
425805-2580513.17313.17
525642-2564213.08913.09
624826-2482612.67312.67
60min148351-4835124.68224.321.3624.7024.341.36
247340-4734024.16624.19
347881-4788124.44224.46
448162-4816224.58524.61
547561-4756124.27824.30
646569-4656923.77223.79
120min180064-8006440.87040.221.3240.9340.281.31
277612-7761239.61839.68
378609-7860940.12740.19
479284-7928440.47240.53
579562-7956240.61440.68
677588-7758839.60639.67
240min1121398-12139861.97061.570.5962.1061.690.60
2119370-11937060.93561.06
3120646-12064661.58661.72
4120756-12075661.64261.77
5121132-12113261.83461.96
6120331-12033161.42561.55
360min1148130-14813075.61675.650.5575.8575.880.55
2146654-14665474.86275.09
3148357-14835775.73175.96
4148443-14844375.77576.01
5148707-14870775.91076.14
6148935-14893576.02676.26
480min1164917-16491784.18584.400.6384.5484.760.63
2163530-16353083.47783.83
3165384-16538484.42384.78
4165746-16574684.60884.97
5166530-16653085.00885.37
6165910-16591084.69285.05
600min1174412-17441289.03289.670.8089.5390.170.80
2173577-17357788.60589.10
3175838-17583889.76090.26
4176347-17634790.01990.52
5176429-17642990.06190.56
6177348-17734890.53091.03
720min1180781-18078192.28392.820.7192.9393.470.71
2179774-17977491.76992.41
3182150-18215092.98293.63
4182626-18262693.22593.88
5182549-18254993.18593.84
6183127-18312793.48094.13
960min1187277-18727795.59996.230.7196.4097.030.71
2186701-18670195.30596.10
3188913-18891396.43497.24
4189798-18979896.88697.69
5188385-18838596.16496.97
6190009-19000996.99397.80
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190100-19010097.04097.790.7998.0098.750.78
2189728-18972896.85097.80
3191859-19185997.93898.90
4192426-19242698.22799.19
5191508-19150897.75998.73
6193777-19377798.91799.88
1440min1190997-19099797.49898.340.6298.6299.460.61
2191563-19156397.78798.90
3193071-19307198.55699.68
4193026-19302698.53499.66
5192907-19290798.47399.60
6194266-19426699.167100.30
极限1190578-19057897.28498.230.7798.5799.520.77
2190615-19061597.30398.58
3192872-19287298.45599.75
4193242-19324298.64499.94
5193182-19318298.61399.91
6194075-19407599.069100.36
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500
标示量(mg)30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%
115.351753811752561753551754061753341753460.04
215.331753281753281753280.00
单位质量响应值RSD%判断
11423.1911436.920.09数据可信
供试品溶液-2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%
30min125573-2557313.08013.002.2413.0813.002.25
226059-2605913.32913.33
324964-2496412.76912.77
426033-2603313.31613.32
525133-2513312.85512.86
624702-2470212.63512.63
60min147905-4790524.50324.471.6024.5224.501.59
248777-4877724.94924.97
346984-4698424.03224.05
448659-4865924.88924.91
547072-4707224.07724.10
647695-4769524.39624.42
120min178143-7814339.97039.871.3440.0339.931.35
278916-7891640.36540.43
377520-7752039.65139.71
479261-7926140.54240.61
577417-7741739.59839.66
676436-7643639.09739.16
240min1120055-12005561.40760.891.0761.5461.021.08
2119605-11960561.17761.31
3117880-11788060.29560.42
4120735-12073561.75561.89
5118472-11847260.59860.73
6117571-11757160.13760.26
360min1147247-14724775.31674.881.1375.5575.111.13
2146834-14683475.10575.34
3143815-14381573.56073.79
4148659-14865976.03876.27
5146361-14636174.86375.09
6145476-14547674.41074.64
480min1165105-16510584.45083.681.2284.8184.041.22
2163485-16348583.62283.98
3160657-16065782.17582.53
4166386-16638685.10585.47
5163389-16338983.57283.93
6162608-16260883.17383.52
600min1175322-17532289.67688.951.3490.1789.441.33
2173480-17348088.73489.23
3170423-17042387.17087.66
4177320-17732090.69891.20
5173830-17383088.91389.41
6172992-17299288.48488.97
720min1181479-18147992.82592.191.2893.4792.831.28
2180233-18023392.18892.83
3176717-17671790.39091.02
4183573-18357393.89694.55
5180378-18037892.26292.90
6179045-17904591.58092.22
960min1188534-18853496.43495.761.3397.2496.551.33
2186515-18651595.40196.20
3183326-18332693.77094.55
4190775-19077597.58098.39
5187601-18760195.95796.75
6186510-18651095.39996.19
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1191256-19125697.82697.131.3898.7998.081.38
2189412-18941296.88397.84
3185867-18586795.07096.01
4193701-19370199.077100.05
5190238-19023897.30698.26
6188854-18885496.59897.55
1440min1193351-19335198.89897.881.43100.0298.991.43
2190779-19077997.58298.70
3186873-18687395.58496.68
4194826-19482699.652100.79
5191721-19172198.06499.18
6190568-19056897.47498.58
极限1192948-19294898.69297.721.4299.9899.001.42
2190752-19075297.56898.85
3186577-18657795.43396.69
4194554-19455499.513100.82
5191110-19111097.75299.03
6190338-19033897.35798.63
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