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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
115.061759461766421764601758511759911761780.20
215.101765811767271766540.06
单位质量响应值RSD%判断
11698.4111698.940.01数据可信
供试品溶液-1234026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%
30min123829-2382912.15812.903.2012.1612.903.19
225409-2540912.96412.96
326051-2605113.29213.29
425934-2593413.23213.23
525018-2501812.76412.76
625519-2551913.02013.02
60min141356-4135621.10022.483.6421.1222.503.64
244651-4465122.78122.80
344167-4416722.53522.56
446266-4626623.60523.63
543594-4359422.24222.26
644326-4432622.61622.64
120min167770-6777034.57735.801.7834.6335.861.79
270648-7064836.04536.11
370657-7065736.05036.11
471065-7106536.25836.32
569907-6990735.66735.73
671002-7100236.22636.29
240min1105630-10563053.89455.262.0054.0155.381.99
2107928-10792855.06655.19
3107635-10763554.91755.04
4111781-11178157.03257.15
5107122-10712254.65554.77
6109736-10973655.98956.11
360min1131374-13137467.02967.801.0267.2368.011.02
2133469-13346968.09768.31
3132996-13299667.85668.07
4133303-13330368.01368.23
5131325-13132567.00467.21
6134827-13482768.79069.00
480min1151186-15118677.13777.381.1277.4577.701.12
2151592-15159277.34477.67
3151967-15196777.53577.86
4152654-15265477.88678.22
5148773-14877375.90676.23
6153813-15381378.47778.80
600min1168414-16841485.92786.011.2086.3786.461.19
2168646-16864686.04586.50
3168823-16882386.13586.59
4168495-16849585.96886.43
5165391-16539184.38484.83
6171720-17172087.61488.07
720min1176218-17621889.90889.981.3390.4990.571.33
2176615-17661590.11190.71
3176017-17601789.80690.40
4176131-17613189.86490.47
5172902-17290288.21788.80
6180230-18023091.95592.56
960min1184834-18483494.30494.471.3195.0495.221.31
2184433-18443394.10094.85
3184708-18470894.24094.99
4185553-18555394.67195.42
5182010-18201092.86493.60
6189439-18943996.65497.41
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1188895-18889596.37696.911.8897.2797.811.87
2188387-18838796.11797.02
3190119-19011997.00197.90
4189462-18946296.66697.58
5186121-18612194.96195.85
6196640-196640100.328101.25
1440min1188550-18855096.20097.041.5197.2598.101.51
2189530-18953096.70097.76
3189818-18981896.84797.91
4190804-19080497.35098.42
5187048-18704895.43496.48
6195454-19545499.723100.81
极限1187929-18792995.88497.071.5597.1098.301.55
2189831-18983196.85498.08
3190356-19035697.12298.35
4190551-19055197.22198.46
5187245-18724595.53596.74
6195582-19558299.788101.04
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
115.061754821753021754201751441755031753700.09
215.101756531758281757400.08
单位质量响应值RSD%判断
11644.7511638.410.04数据可信
供试品溶液-1234026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%
30min124431-2443112.52612.822.9112.5312.822.92
224805-2480512.71812.72
325952-2595213.30613.31
425244-2524412.94312.94
525545-2554513.09713.10
623993-2399312.30212.30
60min142362-4236221.72022.403.0121.7422.423.01
244282-4428222.70422.73
345075-4507523.11123.13
444228-4422822.67622.70
544445-4444522.78822.81
641753-4175321.40721.43
120min168473-6847335.10735.812.4935.1635.872.50
269796-6979635.78535.84
370291-7029136.03936.10
471594-7159436.70736.77
571677-7167736.75036.81
667281-6728134.49634.55
240min1107816-10781655.27955.581.9155.3955.691.91
2107576-10757655.15655.27
3109507-10950756.14656.27
4109398-10939856.09056.21
5111015-11101556.91957.04
6105063-10506353.86753.98
360min1134778-13477869.10368.611.1069.3168.821.10
2132960-13296068.17068.38
3132953-13295368.16768.38
4134621-13462169.02269.24
5135780-13578069.61669.83
6131848-13184867.60067.80
480min1154480-15448079.20478.301.0079.5378.631.00
2151637-15163777.74678.07
3151385-15138577.61777.95
4153185-15318578.54078.87
5154425-15442579.17679.51
6151193-15119377.51977.83
600min1172257-17225788.31987.510.9088.7787.960.90
2169804-16980487.06187.51
3169067-16906786.68387.14
4170781-17078187.56288.02
5172725-17272588.55889.02
6169404-16940486.85687.30
720min1181574-18157493.09691.441.1693.7092.041.16
2177728-17772891.12491.72
3176180-17618090.33090.93
4177946-17794691.23591.84
5179972-17997292.27492.89
6176650-17665090.57191.16
960min1190534-19053497.68996.181.0098.4596.931.00
2186919-18691995.83696.59
3185214-18521494.96295.71
4187558-18755896.16496.92
5188795-18879596.79897.56
6186503-18650395.62396.36
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1195727-195727100.35298.441.22101.2799.351.21
2191123-19112397.99198.90
3188715-18871596.75797.67
4191785-19178598.33199.25
5193125-19312599.01899.94
6191467-19146798.16899.07
1440min1196639-196639100.82099.661.34101.91100.741.33
2192808-19280898.85599.93
3190059-19005997.44698.52
4195148-195148100.055101.14
5194606-19460699.777100.87
6196991-196991101.000102.06
极限1197559-197559101.29198.881.42102.55100.131.42
2192141-19214198.51399.75
3189403-18940397.11098.34
4191995-19199598.43899.69
5194059-19405999.497100.75
6192026-19202698.45499.69
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