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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.231726491725041724931721941723991724480.10
215.151722301720061721180.10
单位质量响应值RSD%判断
11322.9211360.920.24数据可信
供试品溶液-1231323批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min131960-3196016.89017.411.6816.8917.421.68
233285-3328517.59117.59
333494-3349417.70117.70
432876-3287617.37417.37
533278-3327817.58717.59
632823-3282317.34617.35
60min152626-5262627.81228.892.0927.8428.922.09
254589-5458928.84928.88
355915-5591529.55029.58
454422-5442228.76128.79
555047-5504729.09129.12
655429-5542929.29329.32
120min185516-8551645.19446.291.5045.2746.371.50
287284-8728446.12846.21
389261-8926147.17347.25
487549-8754946.26846.35
587231-8723146.10046.18
688718-8871846.88646.96
240min1130553-13055368.99569.850.9069.1470.000.90
2132594-13259470.07470.23
3133614-13361470.61370.77
4131806-13180669.65769.81
5131249-13124969.36369.52
6133224-13322470.40770.56
360min1158735-15873583.88984.470.6784.1584.740.67
2161338-16133885.26485.54
3159176-15917684.12284.40
4159358-15935884.21884.49
5159406-15940684.24384.51
6161002-16100285.08785.36
480min1178318-17831894.23894.960.9694.6495.370.96
2182676-18267696.54196.95
3179323-17932394.76995.18
4178660-17866094.41994.83
5178370-17837094.26694.68
6180737-18073795.51795.93
600min1187768-18776899.23299.720.9999.79100.290.99
2191550-191550101.231101.81
3187423-18742399.05099.62
4187654-18765499.17299.74
5187226-18722698.94699.51
6190559-190559100.707101.28
720min1191761-191761101.343101.791.06102.07102.531.06
2195678-195678103.413104.16
3191147-191147101.018101.76
4191356-191356101.128101.86
5191016-191016100.949101.68
6194717-194717102.905103.65
960min1194148-194148102.604102.781.04103.50103.681.04
2197421-197421104.334105.25
3192778-192778101.880102.79
4192933-192933101.962102.86
5193048-193048102.023102.92
6196552-196552103.874104.79
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193505-193505102.264102.621.12103.33103.701.11
2197656-197656104.458105.55
3192344-192344101.651102.73
4192344-192344101.651102.72
5193244-193244102.126103.20
6195945-195945103.554104.64
1440min1192814-192814101.899102.141.11103.14103.391.11
2196781-196781103.996105.26
3191534-191534101.223102.47
4191547-191547101.229102.47
5192004-192004101.471102.71
6194955-194955103.030104.29
极限1192304-192304101.629102.011.19103.04103.431.19
2196702-196702103.954105.39
3191428-191428101.167102.58
4191379-191379101.141102.55
5191322-191322101.111102.52
6195023-195023103.066104.50
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.231724461722721723781727851724181724600.12
215.151728401729711729060.06
单位质量响应值RSD%判断
11323.7011412.940.56数据可信
供试品溶液-1231323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%
30min125024-2502413.19413.002.3813.1913.002.36
224271-2427112.79712.80
325512-2551213.45213.45
424921-2492113.14013.14
524272-2427212.79812.80
623967-2396712.63712.64
60min142894-4289422.61622.202.3422.6422.222.34
241995-4199522.14222.16
343412-4341222.89022.91
441805-4180522.04222.06
541904-4190422.09422.12
640572-4057221.39221.41
120min169589-6958936.69236.251.1636.7536.311.16
268541-6854136.13936.20
369548-6954836.67036.73
468964-6896436.36236.42
568444-6844436.08836.15
667469-6746935.57435.63
240min1107365-10736556.61055.571.6156.7355.691.61
2105211-10521155.47455.59
3105015-10501555.37155.49
4107182-10718256.51356.63
5104808-10480855.26155.38
6102805-10280554.20554.32
360min1132919-13291970.08369.001.5170.3069.211.50
2131172-13117269.16269.37
3130197-13019768.64868.86
4132932-13293270.09070.30
5130285-13028568.69468.90
6127714-12771467.33967.55
480min1152431-15243180.37179.481.4680.7079.811.45
2150495-15049579.35079.68
3150004-15000479.09279.42
4153859-15385981.12481.45
5150205-15020579.19879.52
6147499-14749977.77178.09
600min1164720-16472086.85185.911.2687.3286.371.26
2161934-16193485.38285.84
3163613-16361386.26786.73
4165491-16549187.25787.72
5161834-16183485.32985.79
6160008-16000884.36684.81
720min1172339-17233990.86890.111.1991.4890.711.19
2170301-17030189.79390.39
3170105-17010589.69090.29
4174163-17416391.83092.44
5170053-17005389.66390.26
6168427-16842788.80589.39
960min1183359-18335996.67895.601.1697.4496.351.16
2180553-18055395.19995.95
3180232-18023295.03095.78
4184224-18422497.13497.90
5180879-18087995.37196.12
6178618-17861894.17994.92
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1188254-18825499.25998.391.14100.1899.301.15
2185901-18590198.01998.93
3185560-18556097.83998.75
4189924-189924100.140101.07
5186043-18604398.09499.00
6183963-18396396.99797.89
1440min1191180-191180100.80299.991.21101.89101.071.21
2188574-18857499.428100.50
3188348-18834899.309100.38
4193456-193456102.002103.09
5189171-18917199.743100.81
6187140-18714098.67299.73
极限1190873-190873100.64099.771.08101.90101.011.08
2188231-18823199.247100.49
3188346-18834699.308100.55
4192413-192413101.452102.71
5188650-18865099.468100.71
6186816-18681698.50199.72
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