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%
1 14.941729271738781736891737021737511735890.22
2 14.941734891735471735180.03
单位质量响应值RSD%判断
11619.0811614.320.03数据可信
供试品溶液-1276525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%
30min124514-2451412.59612.313.2412.6012.313.25
224031-2403112.34712.35
324638-2463812.65912.66
423941-2394112.30112.30
522480-2248011.55011.55
624158-2415812.41312.41
60min142819-4281922.00121.283.1822.0221.303.18
241014-4101421.07321.09
342301-4230121.73521.76
440809-4080920.96820.99
539270-3927020.17720.20
642286-4228621.72721.75
120min166769-6676934.30734.112.7834.3634.162.79
265760-6576033.78833.84
367841-6784134.85834.91
466483-6648334.16034.22
563138-6313832.44132.49
668329-6832935.10835.17
240min1105686-10568654.30354.061.9754.4254.171.98
2105036-10503653.96954.08
3106927-10692754.94055.06
4105120-10512054.01254.12
5101385-10138552.09352.20
6107108-10710855.03355.15
360min1132051-13205167.84967.531.6368.0567.741.63
2130636-13063667.12267.32
3133359-13335968.52168.73
4131389-13138967.50967.71
5127704-12770465.61665.81
6133488-13348868.58868.79
480min1150434-15043477.29577.050.9877.6177.370.99
2149889-14988977.01577.33
3151237-15123777.70778.03
4149563-14956376.84777.16
5147348-14734875.70976.01
6151331-15133177.75678.08
600min1162314-16231483.39984.072.2383.8584.522.23
2162321-16232183.40283.84
3170017-17001787.35787.81
4164273-16427384.40584.85
5158991-15899181.69182.12
6163810-16381084.16884.62
720min1170902-17090287.81287.891.0988.4088.481.09
2170644-17064487.67988.26
3173432-17343289.11189.71
4170480-17048087.59588.18
5168183-16818386.41486.98
6172695-17269588.73389.32
960min1181789-18178993.40593.451.0394.1494.181.04
2181208-18120893.10793.83
3184616-18461694.85895.60
4180571-18057192.78093.51
5179582-17958292.27192.98
6183475-18347594.27295.01
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187483-18748396.33196.971.1297.2297.861.12
2190845-19084598.05898.94
3190829-19082998.05098.95
4186681-18668195.91996.80
5186385-18638595.76796.63
6190188-19018897.72198.62
1440min1190829-19082998.05098.311.2599.1099.361.25
2190066-19006697.65898.70
3194694-194694100.036101.10
4190208-19020897.73198.78
5188511-18851196.85997.88
6193740-19374099.546100.61
极限1191975-19197598.63998.581.2199.8599.801.21
2192066-19206698.68699.89
3195010-195010100.198101.43
4190078-19007897.66498.87
5188563-18856396.88698.07
6193519-19351999.432100.66
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%
1 14.941731461738801735401739211742541737480.25
2 14.941745351742031743690.14
单位质量响应值RSD%判断
11629.7211671.290.26数据可信
供试品溶液-1276525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%
30min125581-2558113.10612.633.4613.1112.633.46
225118-2511812.86912.87
324210-2421012.40312.40
424435-2443512.51912.52
525257-2525712.94012.94
623261-2326111.91711.92
60min144366-4436622.73021.473.2522.7521.503.25
242313-4231321.67821.70
341438-4143821.23021.25
441723-4172321.37621.40
541310-4131021.16421.19
640347-4034720.67120.69
120min170519-7051936.12834.652.6836.1934.712.69
268430-6843035.05835.12
366794-6679434.22034.28
468124-6812434.90134.96
566643-6664334.14334.20
665283-6528333.44633.50
240min1110278-11027856.49854.931.4556.6255.041.45
2106349-10634954.48554.60
3107165-10716554.90355.02
4106847-10684754.74054.85
5106035-10603554.32454.44
6106604-10660454.61654.73
360min1134878-13487869.10167.811.2469.3268.021.25
2131804-13180467.52667.73
3132452-13245267.85868.06
4133227-13322768.25568.46
5131818-13181867.53367.74
6129977-12997766.59066.79
480min1153414-15341478.59877.101.2178.9377.421.21
2149692-14969276.69177.01
3150364-15036477.03577.35
4150740-15074077.22877.55
5150903-15090377.31177.63
6147860-14786075.75276.06
600min1164983-16498384.52583.501.0584.9883.951.05
2162095-16209583.04583.49
3163351-16335183.68884.13
4162623-16262383.31583.76
5164548-16454884.30284.75
6160357-16035782.15582.59
720min1173972-17397289.13087.601.1289.7388.181.12
2169609-16960986.89587.48
3171257-17125787.73988.32
4170446-17044687.32387.91
5172039-17203988.14088.73
6168539-16853986.34686.92
960min1186259-18625995.42593.111.5596.1793.841.55
2180609-18060992.53093.26
3181641-18164193.05993.79
4180885-18088592.67293.40
5183211-18321193.86394.60
6177864-17786491.12491.84
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1191341-19134198.02896.111.4698.9497.001.46
2186508-18650895.55296.44
3187886-18788696.25897.15
4186371-18637195.48296.37
5189786-18978697.23298.12
6183657-18365794.09294.96
1440min1193972-19397299.37697.631.50100.4598.671.49
2189720-18972097.19898.24
3191515-19151598.11899.16
4189382-18938297.02598.07
5192755-19275598.75399.80
6185984-18598495.28496.31
极限1194322-19432299.55697.741.23100.7998.951.23
2189387-18938797.02798.23
3191015-19101597.86199.07
4189424-18942497.04698.25
5192565-19256598.65599.87
6188015-18801596.32497.51
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