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%
115.061744461746241740901745111750671745480.21
215.101735981738701737340.12
单位质量响应值RSD%判断
11590.1711505.560.52数据可信
供试品溶液-1270307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%
30min123730-2373012.26612.292.2012.2712.292.19
223824-2382412.31412.31
324321-2432112.57112.57
422984-2298411.88011.88
524340-2434012.58112.58
623445-2344512.11812.12
60min140837-4083721.10820.991.8221.1321.011.81
240755-4075521.06621.09
341519-4151921.46021.48
439381-3938120.35520.38
540969-4096921.17621.20
640187-4018720.77220.79
120min167059-6705934.66234.231.7734.7234.291.77
265502-6550233.85733.91
367252-6725234.76134.82
465082-6508233.64033.69
567518-6751834.89934.96
664972-6497233.58333.64
240min1102859-10285953.16652.811.3653.2852.931.36
2102238-10223852.84552.96
3103590-10359053.54453.66
499948-9994851.66151.77
5103237-10323753.36153.48
6101173-10117352.29452.41
360min1128735-12873566.54166.051.3166.7466.251.31
2128809-12880966.57966.78
3128084-12808466.20466.41
4124754-12475464.48364.68
5129271-12927166.81867.02
6127090-12709065.69065.89
480min1150792-15079277.94277.321.0778.2577.641.07
2150847-15084777.97078.28
3148917-14891776.97277.29
4147094-14709476.03076.33
5151127-15112778.11578.43
6148815-14881576.92077.23
600min1162866-16286684.18283.571.0984.6384.011.09
2163222-16322284.36684.81
3161029-16102983.23383.68
4159016-15901682.19282.62
5163376-16337684.44684.89
6160611-16061183.01783.45
720min1170675-17067588.21987.781.2388.8088.361.23
2170681-17068188.22288.80
3169871-16987187.80388.38
4166535-16653586.07986.65
5172613-17261389.22089.81
6168552-16855287.12187.70
960min1180204-18020493.14492.721.1793.8793.441.17
2180719-18071993.41094.14
3179152-17915292.60093.33
4176317-17631791.13591.85
5182099-18209994.12494.86
6177794-17779491.89892.62
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187001-18700196.65796.151.2897.5497.031.28
2187621-18762196.97897.86
3185493-18549395.87896.76
4182445-18244594.30295.16
5189083-18908397.73498.62
6184521-18452195.37696.25
1440min1188150-18815097.25196.931.1998.3097.961.18
2189414-18941497.90598.95
3186992-18699296.65397.69
4184135-18413595.17696.20
5190198-19019898.31099.36
6186237-18623796.26297.29
极限1188608-18860897.48896.931.2598.7098.131.24
2189211-18921197.80099.01
3187527-18752796.92998.13
4183812-18381295.00996.19
5190115-19011598.26799.48
6185912-18591296.09497.29
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%
115.061734481730271736111735441737881734840.17
215.101739971737241738600.12
单位质量响应值RSD%判断
11519.5211513.910.04数据可信
供试品溶液-1270307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%
30min124248-2424812.56712.743.0212.5712.743.02
225387-2538713.15713.16
323907-2390712.39012.39
425254-2525413.08813.09
523654-2365412.25912.26
625051-2505112.98312.98
60min141567-4156721.54321.931.8821.5621.951.89
243188-4318822.38322.41
341577-4157721.54821.57
442908-4290822.23822.26
541636-4163621.57921.60
642999-4299922.28522.31
120min167689-6768935.08135.963.1435.1436.023.14
269552-6955236.04736.11
366800-6680034.62134.68
469565-6956536.05436.11
569538-6953836.04036.10
673125-7312537.89937.96
240min1102319-10231953.02954.412.2453.1454.522.24
2105032-10503254.43554.55
3103702-10370253.74653.86
4106362-10636255.12555.24
5103595-10359553.69053.81
6108846-10884656.41256.53
360min1127331-12733165.99267.141.1066.2067.351.10
2129315-12931567.02067.23
3129088-12908866.90367.11
4131556-13155668.18268.39
5129499-12949967.11667.32
6130468-13046867.61867.83
480min1148312-14831276.86678.491.2277.1878.801.22
2150135-15013577.81178.13
3152057-15205778.80779.12
4153179-15317979.38979.71
5152387-15238778.97879.30
6152554-15255479.06579.39
600min1159642-15964282.73884.611.4083.1885.061.39
2161281-16128183.58884.04
3164719-16471985.36985.82
4165449-16544985.74886.20
5164185-16418585.09385.54
6164300-16430085.15285.61
720min1166954-16695486.52888.601.5387.1189.191.52
2168556-16855687.35887.95
3172983-17298389.65290.24
4173370-17337089.85390.45
5171509-17150988.88889.48
6172287-17228789.29289.89
960min1175954-17595491.19293.481.6291.9294.221.61
2177618-17761892.05592.79
3182858-18285894.77095.51
4182943-18294394.81495.56
5181042-18104293.82994.57
6181809-18180994.22794.98
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1182411-18241194.53996.861.6195.4197.751.61
2184028-18402895.37796.27
3190001-19000198.47299.37
4189267-18926798.09299.00
5187697-18769797.27898.17
6187910-18791097.38998.30
1440min1183807-18380795.26297.711.7096.3098.771.70
2185220-18522095.99497.04
3191108-19110899.046100.11
4191298-19129899.145100.22
5190023-19002398.48499.54
6189750-18975098.34299.41
极限1183625-18362595.16897.501.7796.3698.711.77
2184196-18419695.46496.67
3191314-19131499.153100.38
4190455-19045598.70899.94
5189668-18966898.30099.52
6189436-18943698.18099.41
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