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%
115.011697471698851700471696801701511699020.12
215.101700301696731698520.15
单位质量响应值RSD%判断
11319.2511248.480.45数据可信
供试品溶液-24091001-1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%
30min122965-2296511.89911.842.9911.9011.842.99
222183-2218311.49411.49
323341-2334112.09412.09
422460-2246011.63711.64
522225-2222511.51511.52
623892-2389212.37912.38
60min141723-4172321.61821.382.3121.6421.402.32
240039-4003920.74520.76
342083-4208321.80421.82
440813-4081321.14621.17
540503-4050320.98621.00
642434-4243421.98622.01
120min168923-6892335.71135.172.2135.7735.222.22
265141-6514133.75133.80
368502-6850235.49335.55
467663-6766335.05835.11
567658-6765835.05535.11
669335-6933535.92435.98
240min1103840-10384053.80254.160.8053.9254.280.80
2103229-10322953.48653.60
3104751-10475154.27454.39
4105038-10503854.42354.54
5104888-10488854.34554.46
6105472-10547254.64854.76
360min1128862-12886266.76767.120.7466.9767.330.73
2128109-12810966.37766.58
3129574-12957467.13667.34
4130226-13022667.47367.68
5129813-12981367.25967.46
6130734-13073467.73767.94
480min1147760-14776076.55877.000.5676.8777.320.56
2148263-14826376.81977.13
3148392-14839276.88677.20
4149498-14949877.45977.77
5148000-14800076.68377.00
6149778-14977877.60477.92
600min1158191-15819181.96382.560.7582.4183.000.75
2159477-15947782.62983.07
3159048-15904882.40782.85
4160259-16025983.03483.48
5158006-15800681.86782.31
6161077-16107783.45883.91
720min1164954-16495485.46785.890.8886.0586.480.87
2166764-16676486.40586.98
3165376-16537685.68686.27
4166263-16626386.14586.73
5163603-16360384.76785.35
6167696-16769686.88887.48
960min1172447-17244789.34989.741.0490.0790.461.04
2174807-17480790.57291.29
3172411-17241189.33190.06
4174028-17402890.16890.90
5170369-17036988.27388.99
6175105-17510590.72691.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1175538-17553890.95191.551.1791.8292.421.17
2178990-17899092.73993.61
3175957-17595791.16892.04
4177294-17729491.86192.74
5173618-17361889.95690.82
6178756-17875692.61893.50
1440min1177199-17719991.81192.661.2492.8393.691.23
2181317-18131793.94594.97
3179298-17929892.89993.93
4179361-17936192.93193.96
5175340-17534090.84891.87
6180507-18050793.52594.57
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%
115.011698961698691696481699191696061697880.09
215.101703481704561704020.05
单位质量响应值RSD%判断
11311.6611284.900.17数据可信
供试品溶液-24091001-2-1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%
30min123931-2393112.38312.173.2212.3812.173.21
224356-2435612.60312.60
323223-2322312.01712.02
422456-2245611.62011.62
522963-2296311.88211.88
624200-2420012.52312.52
60min142839-4283922.16721.841.6422.1921.861.65
242911-4291122.20522.23
342128-4212821.80021.82
441109-4110921.27221.29
541784-4178421.62221.64
642494-4249421.98922.01
120min171161-7116136.82336.341.4736.8836.401.47
270440-7044036.45036.51
369129-6912935.77135.83
471608-7160837.05437.11
569149-6914935.78235.84
669873-6987336.15636.21
240min1106576-10657655.14954.721.4155.2754.841.41
2105840-10584054.76854.89
3107375-10737555.56255.68
4103256-10325653.43153.55
5106566-10656655.14455.26
6104820-10482054.24054.36
360min1132228-13222868.42367.881.0768.6368.091.07
2131421-13142168.00568.22
3132976-13297668.81069.02
4129738-12973867.13467.34
5131333-13133367.96068.17
6129388-12938866.95367.16
480min1151837-15183778.57077.960.9378.8978.280.93
2151385-15138578.33678.66
3152032-15203278.67078.99
4149743-14974377.48677.80
5150539-15053977.89878.22
6148402-14840276.79277.11
600min1162422-16242284.04783.441.1784.5083.891.17
2162182-16218283.92384.38
3163343-16334384.52384.98
4160568-16056883.08883.53
5160925-16092583.27283.72
6158003-15800381.76082.21
720min1170178-17017888.06087.021.2988.6687.611.29
2169346-16934687.63088.22
3170000-17000087.96888.56
4167560-16756086.70687.29
5167466-16746686.65787.25
6164465-16446585.10485.69
960min1176641-17664191.40590.831.2992.1591.571.29
2176845-17684591.51092.25
3177626-17762691.91492.66
4176010-17601091.07891.81
5174693-17469390.39791.13
6171372-17137288.67889.40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1180295-18029593.29592.821.0194.1993.711.01
2180479-18047993.39194.28
3181179-18117993.75394.65
4179792-17979293.03593.92
5178173-17817392.19793.08
6176337-17633791.24792.12
1440min1182280-18228094.32393.711.3795.3794.751.36
2182843-18284394.61495.66
3183478-18347894.94395.99
4181295-18129593.81394.85
5179977-17997793.13194.17
6176723-17672391.44792.47
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%
115.011700431700611699441702631701171700860.07
215.101706481706421706450.01
单位质量响应值RSD%判断
11331.5111300.990.20数据可信
供试品溶液-24091001-2-2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%
30min123821-2382112.30711.784.3212.3111.784.33
223317-2331712.04612.05
322328-2232811.53611.54
422654-2265411.70411.70
521164-2116410.93410.93
623578-2357812.18112.18
60min142724-4272422.07321.383.8122.0921.403.80
241951-4195121.67321.69
341177-4117721.27421.29
441223-4122321.29721.32
538496-3849619.88919.91
642752-4275222.08722.11
120min169852-6985236.08835.053.5336.1535.113.53
268464-6846435.37135.43
368108-6810835.18735.24
467785-6778535.02035.08
563249-6324932.67732.73
669598-6959835.95736.01
240min1107000-10700055.28053.863.1855.4053.973.18
2104313-10431353.89254.01
3105846-10584654.68454.80
4104505-10450553.99154.10
597820-9782050.53850.64
6106012-10601254.77054.89
360min1132721-13272168.56967.202.5768.7867.412.57
2129636-12963666.97567.18
3132377-13237768.39168.60
4130312-13031267.32467.53
5123718-12371863.91764.11
6131672-13167268.02768.24
480min1153881-15388179.50177.322.5079.8277.642.50
2148493-14849376.71777.03
3152339-15233978.70479.02
4149809-14980977.39777.71
5143125-14312573.94474.24
6150370-15037077.68778.01
600min1163048-16304884.23783.031.9384.6983.481.94
2161725-16172583.55384.00
3163515-16351584.47884.93
4160459-16045982.89983.34
5154930-15493080.04380.46
6160630-16063082.98883.44
720min1169275-16927587.45486.161.8588.0586.751.85
2165197-16519785.34785.93
3170512-17051288.09388.68
4166862-16686286.20786.79
5161841-16184183.61384.17
6166992-16699286.27486.86
960min1176534-17653491.20489.941.5391.9590.671.54
2172513-17251389.12789.85
3177264-17726491.58192.32
4174119-17411989.95790.68
5169992-16999287.82488.52
6174133-17413389.96490.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1179788-17978892.88591.631.4693.7892.511.47
2175569-17556990.70691.58
3180802-18080293.40994.30
4177121-17712191.50892.38
5173851-17385189.81890.66
6177023-17702391.45792.34
1440min1180486-18048693.24692.421.3794.3093.451.37
2176509-17650991.19192.22
3182645-18264594.36195.41
4178863-17886392.40793.44
5176208-17620891.03692.02
6178583-17858392.26393.30
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