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500
标示量(mg)30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%
115.003417523412673414533413463417563415150.07
215.103414693413133413910.04
单位质量响应值RSD%判断
22767.6722608.680.50数据可信
供试品溶液-24093001-1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%
30min150029-5002912.89212.344.9812.8912.344.97
248106-4810612.39612.40
348595-4859512.52212.52
448820-4882012.58012.58
543214-4321411.13611.14
648668-4866812.54112.54
60min190945-9094523.43523.135.3523.4623.155.34
288446-8844622.79122.81
393583-9358324.11524.14
488949-8894922.92122.94
581521-8152121.00721.03
695126-9512624.51324.53
120min1151825-15182539.12338.662.7539.1838.722.75
2148233-14823338.19838.26
3155055-15505539.95640.02
4150545-15054538.79438.85
5142936-14293636.83336.89
6151527-15152739.04739.11
240min1230493-23049359.39558.892.3959.5259.022.40
2226680-22668058.41358.54
3231058-23105859.54159.67
4231481-23148159.65059.77
5218313-21831356.25756.37
6233238-23323860.10360.23
360min1280107-28010772.18071.631.4072.4071.851.40
2275270-27527070.93471.15
3279856-27985672.11672.34
4280878-28087872.37972.60
5271273-27127369.90470.11
6280456-28045672.27072.50
480min1309697-30969779.80579.581.3180.1579.921.31
2306330-30633078.93879.28
3310478-31047880.00680.35
4309109-30910979.65480.00
5302687-30268777.99978.32
6314630-31463081.07681.42
600min1327036-32703684.27383.870.9784.7584.340.98
2324491-32449183.61784.09
3327077-32707784.28484.76
4325961-32596183.99684.47
5319678-31967882.37782.83
6328613-32861384.68085.16
720min1337017-33701786.84586.310.8987.4686.920.90
2334014-33401486.07186.68
3336316-33631686.66587.29
4335908-33590886.55987.18
5329318-32931884.86185.45
6337080-33708086.86287.49
960min1347905-34790589.65189.260.5990.4190.010.60
2346188-34618889.20989.96
3347168-34716889.46190.23
4347438-34743889.53190.29
5342418-34241888.23788.97
6347095-34709589.44290.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1354692-35469291.40090.810.7592.3191.710.75
2351650-35165090.61691.52
3353287-35328791.03891.95
4353217-35321791.02091.93
5347464-34746489.53790.42
6354058-35405891.23792.15
1440min1357169-35716992.03891.630.7593.1092.690.76
2354699-35469991.40292.45
3356773-35677391.93693.00
4357477-35747792.11893.18
5350563-35056390.33691.37
6356935-35693591.97893.05
极限1355968-35596891.72991.550.8292.9592.760.83
2354210-35421091.27692.48
3356017-35601791.74192.96
4357719-35771992.18093.40
5349981-34998190.18691.37
6357680-35768092.17093.39
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500
标示量(mg)30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%
115.003414623415393413473417873412643414800.06
215.103405693412883409280.15
单位质量响应值RSD%判断
22765.3322578.010.59数据可信
供试品溶液-24093001-2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%
30min146477-4647711.98513.067.8011.9913.067.78
254220-5422013.98213.98
348534-4853412.51612.52
449727-4972712.82312.82
548178-4817812.42412.42
656665-5666514.61314.61
60min183733-8373321.59322.642.6321.6122.662.64
289376-8937623.04823.07
387097-8709722.46022.48
489568-8956823.09823.12
587240-8724022.49722.52
689715-8971523.13523.16
120min1140102-14010236.12937.803.4536.1937.863.45
2145773-14577337.59137.65
3145764-14576437.58937.65
4146521-14652137.78437.84
5145663-14566337.56337.62
6155703-15570340.15240.22
240min1217535-21753556.09757.381.6556.2157.501.65
2221616-22161657.15057.27
3221744-22174457.18357.30
4223580-22358057.65657.78
5221811-22181157.20057.32
6228755-22875558.99159.12
360min1267454-26745468.97070.021.0969.1870.241.09
2269260-26926069.43669.66
3271724-27172470.07170.29
4272257-27225770.20970.43
5272335-27233570.22970.45
6276019-27601971.17971.41
480min1297198-29719876.64077.951.1576.9778.281.15
2299906-29990677.33977.67
3303210-30321078.19178.52
4301580-30158077.77178.11
5304822-30482278.60778.94
6306836-30683679.12679.47
600min1314114-31411481.00382.201.0881.4682.661.08
2317709-31770981.93082.39
3318383-31838382.10482.57
4316894-31689481.72082.19
5323607-32360783.45183.91
6321772-32177282.97883.46
720min1324155-32415583.59284.850.9884.1885.450.98
2329696-32969685.02185.62
3328046-32804684.59585.20
4327433-32743384.43785.04
5332996-33299685.87286.48
6331801-33180185.56486.18
960min1333410-33341085.97987.451.2586.7188.191.24
2338626-33862687.32488.07
3338266-33826687.23187.97
4337164-33716486.94787.69
5345971-34597189.21889.96
6341211-34121187.99088.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1341072-34107287.95589.011.0888.8289.891.08
2343773-34377388.65189.54
3346100-34610089.25190.14
4341663-34166388.10788.99
5350862-35086290.47991.37
6347426-34742689.59390.50
1440min1342791-34279188.39889.701.2589.4190.741.25
2346915-34691589.46190.50
3346732-34673289.41490.45
4344685-34468588.88689.92
5354312-35431291.36992.41
6351607-35160790.67191.73
极限1343326-34332688.53689.721.2689.7090.901.26
2346827-34682789.43990.62
3346165-34616589.26890.45
4344514-34451488.84290.02
5353485-35348591.15692.35
6353152-35315291.07092.28
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500
标示量(mg)30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%
115.003413553410833410943410523411833411530.04
215.103411463407193409320.09
单位质量响应值RSD%判断
22743.5322578.280.52数据可信
供试品溶液-24093001-3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%
30min147182-4718212.17312.956.7512.1712.956.76
250105-5010512.92712.93
349786-4978612.84512.84
456461-5646114.56714.57
550316-5031612.98112.98
647232-4723212.18612.19
60min185648-8564822.09722.822.3622.1222.842.36
289542-8954223.10223.12
389364-8936423.05623.08
490792-9079223.42423.45
589272-8927223.03223.05
686069-8606922.20622.23
120min1141882-14188236.60537.561.9036.6637.621.91
2146492-14649237.79537.85
3145573-14557337.55837.62
4149530-14953038.57938.64
5147006-14700637.92737.99
6143121-14312136.92536.98
240min1214952-21495255.45756.531.5055.5856.651.50
2217728-21772856.17356.30
3220349-22034956.85056.97
4223639-22363957.69957.83
5221451-22145157.13457.26
6216461-21646155.84755.97
360min1261870-26187067.56268.591.2767.7768.811.27
2264176-26417668.15768.37
3266910-26691068.86269.08
4271068-27106869.93570.16
5267784-26778469.08869.31
6263425-26342567.96368.18
480min1292976-29297675.58776.091.1475.9176.421.14
2291203-29120375.13075.46
3294527-29452775.98776.32
4300596-30059677.55377.89
5296840-29684076.58476.92
6293460-29346075.71276.04
600min1311834-31183480.45380.371.1480.9080.831.14
2305664-30566478.86179.32
3311366-31136680.33280.79
4316455-31645581.64582.11
5313290-31329080.82881.29
6310540-31054080.11980.57
720min1316433-31643381.63982.431.1182.2283.021.11
2315166-31516681.31281.90
3319527-31952782.43783.03
4325253-32525383.91584.52
5320252-32025282.62583.22
6320277-32027782.63183.22
960min1326423-32642384.21785.011.2184.9485.741.20
2324213-32421383.64684.37
3329444-32944484.99685.73
4335687-33568786.60787.35
5330590-33059085.29286.03
6330655-33065585.30886.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1331313-33131385.47886.301.2086.3487.181.20
2329237-32923784.94385.80
3334686-33468686.34887.22
4340839-34083987.93688.83
5335547-33554786.57187.45
6335466-33546686.55087.41
1440min1332498-33249885.78486.961.1386.7987.971.13
2333059-33305985.92986.93
3337142-33714286.98288.00
4342680-34268088.41189.45
5338404-33840487.30888.33
6338489-33848987.33088.34
极限1333502-33350286.04386.931.1487.1988.091.14
2332340-33234085.74386.89
3337087-33708786.96888.13
4343126-34312688.52689.71
5338116-33811687.23388.40
6337383-33738387.04488.20
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢超君 于 2024-10-15 15:39:04 完成)
生成报告数据部分下载报告(谢超君 于 2024-10-15 15:39:26 完成)
Current page cost:79 ms