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%
115.023415423409943407323407963401253408380.15
215.073404953407743406340.06
单位质量响应值RSD%判断
22692.2822603.450.28数据可信
供试品溶液-24091201-1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%
30min146727-4672712.06212.302.1212.0612.302.12
249382-4938212.74812.75
348088-4808812.41412.41
447425-4742512.24312.24
547527-4752712.26912.27
646667-4666712.04712.05
60min184612-8461221.84222.321.9921.8622.342.00
289239-8923923.03723.06
387462-8746222.57822.60
485795-8579522.14822.17
586573-8657322.34822.37
684991-8499121.94021.96
120min1140678-14067836.31536.741.7036.3736.801.70
2145638-14563837.59637.66
3143241-14324136.97737.04
4140969-14096936.39036.45
5144124-14412437.20537.26
6139223-13922335.94036.00
240min1217214-21721456.07356.021.0656.1956.141.06
2219622-21962256.69456.82
3219591-21959156.68656.81
4214645-21464555.40955.53
5216587-21658755.91156.03
6214423-21442355.35255.47
360min1267560-26756069.06968.620.9669.2868.830.96
2268974-26897469.43469.65
3266401-26640168.77068.98
4262576-26257667.78367.99
5266397-26639768.76968.98
6263005-26300567.89368.10
480min1305300-30530078.81277.711.2979.1478.041.29
2306065-30606579.00979.34
3300921-30092177.68178.01
4296471-29647176.53276.86
5299106-29910677.21377.54
6298354-29835477.01877.34
600min1324686-32468683.81682.221.5584.2782.681.55
2324375-32437583.73684.20
3317367-31736781.92782.39
4312629-31262980.70381.15
5315923-31592381.55482.01
6316116-31611681.60482.05
720min1336957-33695786.98484.961.6087.5885.551.59
2333543-33354386.10286.71
3327762-32776284.61085.21
4322375-32237583.21983.80
5327193-32719384.46385.06
6326820-32682084.36784.95
960min1347084-34708489.59887.851.3490.3488.591.33
2344277-34427788.87389.62
3339228-33922887.57088.31
4334749-33474986.41487.14
5337716-33771687.18087.91
6338837-33883787.46988.20
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1353096-35309691.15089.701.1592.0490.581.15
2350839-35083990.56791.46
3346883-34688389.54690.43
4341848-34184888.24689.11
5345835-34583589.27590.15
6346312-34631289.39990.27
1440min1356451-35645192.01690.751.0793.0691.781.07
2354344-35434491.47292.52
3352034-35203490.87691.91
4345670-34567089.23390.25
5349899-34989990.32591.35
6350952-35095290.59691.62
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%
115.023408423409483407483410103405763408250.06
215.073400663399313399980.03
单位质量响应值RSD%判断
22691.4122561.250.41数据可信
供试品溶液-24091201-2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%
30min148303-4830312.48112.641.9912.4812.642.00
248311-4831112.48312.48
350413-5041313.02613.03
447795-4779512.35012.35
549587-4958712.81312.81
649048-4904812.67412.67
60min185239-8523922.02522.251.4022.0522.271.40
285357-8535722.05622.08
387831-8783122.69522.72
485340-8534022.05122.07
587470-8747022.60122.62
685410-8541022.06922.09
120min1138846-13884635.87735.921.1435.9335.971.14
2137176-13717635.44535.50
3140509-14050936.30636.37
4138107-13810735.68635.74
5141267-14126736.50236.56
6138080-13808035.67935.74
240min1211707-21170754.70354.820.7754.8254.930.77
2211875-21187554.74754.86
3214287-21428755.37055.49
4210903-21090354.49654.61
5213894-21389455.26855.39
6210206-21020654.31554.43
360min1263334-26333468.04367.581.0068.2567.781.00
2263606-26360668.11468.32
3263598-26359868.11168.32
4258333-25833366.75166.96
5262142-26214267.73567.95
6258146-25814666.70366.91
480min1300791-30079177.72276.921.2078.0477.241.20
2302004-30200478.03578.36
3299158-29915877.30077.63
4294304-29430476.04676.36
5296737-29673776.67477.00
6293159-29315975.75076.07
600min1317499-31749982.03981.451.1282.4981.901.12
2320317-32031782.76783.22
3316531-31653181.78982.24
4311319-31131980.44280.89
5313829-31382981.09181.54
6311765-31176580.55781.00
720min1326811-32681184.44584.061.1885.0384.641.18
2331623-33162385.68986.28
3326750-32675084.42985.02
4322226-32222683.26083.84
5322721-32272183.38883.98
6321731-32173183.13383.71
960min1339559-33955987.73987.411.1888.4788.141.18
2345123-34512389.17789.91
3339469-33946987.71688.45
4335086-33508686.58387.30
5335526-33552686.69787.42
6334971-33497186.55487.27
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1346746-34674689.59689.281.2290.4790.161.22
2352588-35258891.10691.99
3347219-34721989.71890.60
4342257-34225788.43689.30
5342923-34292388.60889.48
6341496-34149688.24089.10
1440min1338959-33895987.58488.802.4188.6189.822.37
2329258-32925885.07786.11
3352000-35200090.95491.98
4346974-34697489.65590.67
5348341-34834190.00891.03
6346521-34652189.53890.55
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