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%
115.063474583475863472113474443470673473530.07
215.103467513461363464440.13
单位质量响应值RSD%判断
23064.6122943.310.38数据可信
供试品溶液-1261778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%
30min144903-4490311.65111.443.7511.6511.443.73
245416-4541611.78411.78
343396-4339611.26011.26
446043-4604311.94711.95
543044-4304411.16911.17
641682-4168210.81510.82
60min176593-7659319.87419.602.8019.8919.622.80
275265-7526519.52919.55
374496-7449619.32919.35
479155-7915520.53820.56
574564-7456419.34719.37
673084-7308418.96318.98
120min1121359-12135931.48931.512.4331.5431.562.43
2121632-12163231.56031.61
3119629-11962931.04031.09
4126986-12698632.94933.00
5120453-12045331.25431.30
6118563-11856330.76430.81
240min1190222-19022249.35749.271.7649.4649.381.76
2188530-18853048.91849.02
3190019-19001949.30449.41
4196096-19609650.88150.99
5187877-18787748.74848.85
6186617-18661748.42248.52
360min1238658-23865861.92561.831.3862.1162.011.38
2237262-23726261.56261.75
3238627-23862761.91762.10
4244255-24425563.37763.57
5234863-23486360.94061.12
6235995-23599561.23461.42
480min1268457-26845769.65769.651.4169.9569.941.41
2266701-26670169.20169.49
3269547-26954769.93970.23
4274465-27446571.21571.51
5262887-26288768.21168.50
6268486-26848669.66469.95
600min1300433-30043377.95377.301.5278.3677.711.52
2296243-29624376.86677.27
3299576-29957677.73178.14
4304000-30400078.87979.30
5290739-29073975.43875.84
6296495-29649576.93277.33
720min1313719-31371981.40180.981.4781.9481.521.47
2310849-31084980.65681.19
3314599-31459981.62982.16
4317429-31742982.36382.91
5303964-30396478.87079.39
6312112-31211280.98481.51
960min1333340-33334086.49286.241.5387.1686.901.53
2330673-33067385.80086.47
3335381-33538187.02187.69
4339291-33929188.03688.72
5324254-32425484.13484.79
6331208-33120885.93986.60
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1346016-34601689.78189.581.4790.6090.391.46
2345374-34537489.61490.42
3347772-34777290.23691.05
4350874-35087491.04191.87
5335841-33584187.14187.94
6345494-34549489.64590.45
1440min1352300-35230091.41191.211.5692.3892.181.55
2351819-35181991.28792.25
3356243-35624392.43493.40
4356554-35655492.51593.50
5341535-34153588.61889.56
6350755-35075591.01091.97
极限1351734-35173491.26491.191.4592.3892.301.44
2351277-35127791.14692.26
3355431-35543192.22493.34
4356453-35645392.48993.63
5342103-34210388.76689.86
6351690-35169091.25392.36
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%
115.063459773459783465983457823461083460890.09
215.103462633463623463120.03
单位质量响应值RSD%判断
22980.6822934.570.15数据可信
供试品溶液-1261778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%
30min141419-4141910.76911.255.3510.7711.255.35
243510-4351011.31211.31
346845-4684512.17912.18
440516-4051610.53410.53
544786-4478611.64411.64
642510-4251011.05211.05
60min172137-7213718.75519.314.0618.7719.334.08
275185-7518519.54819.57
379684-7968420.71720.74
471106-7110618.48718.50
574077-7407719.25919.28
673425-7342519.09019.11
120min1117188-11718830.46831.272.9730.5231.332.96
2121412-12141231.56631.62
3126601-12660132.91532.97
4116799-11679930.36730.42
5119522-11952231.07531.13
6120196-12019631.25031.30
240min1187236-18723648.68049.061.6748.7849.161.67
2190677-19067749.57549.68
3193909-19390950.41550.52
4185332-18533248.18548.28
5186600-18660048.51548.62
6188341-18834148.96749.07
360min1238394-23839461.98161.881.4762.1662.061.47
2241098-24109862.68462.87
3242964-24296463.16963.36
4234299-23429960.91661.10
5234986-23498661.09561.28
6236198-23619861.41061.59
480min1271728-27172870.64769.911.3670.9370.201.36
2271235-27123570.51970.81
3273514-27351471.11271.41
4265665-26566569.07169.35
5265487-26548769.02569.31
6265831-26583169.11469.40
600min1305907-30590779.53377.871.3979.9478.281.39
2299933-29993377.98078.39
3302719-30271978.70579.12
4297234-29723477.27977.67
5295836-29583676.91577.32
6295457-29545776.81777.22
720min1322001-32200183.71881.581.6284.2582.121.62
2314153-31415381.67782.22
3317115-31711582.44783.00
4311108-31110880.88681.41
5309183-30918380.38580.91
6309119-30911980.36980.90
960min1344550-34455089.58086.721.8890.2587.391.87
2334567-33456786.98587.66
3335139-33513987.13487.82
4330789-33078986.00386.66
5329562-32956285.68486.35
6326698-32669884.93985.60
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1356732-35673292.74889.851.8793.5790.661.86
2345583-34558389.84990.67
3347603-34760390.37491.21
4342926-34292689.15889.96
5343025-34302589.18489.99
6337550-33755087.76088.57
1440min1361399-36139993.96191.361.6794.9492.321.66
2350516-35051691.13192.10
3352875-35287591.74592.73
4349744-34974490.93191.88
5350486-35048691.12492.08
6343335-34333589.26490.22
极限1360937-36093793.84191.361.4894.9892.471.48
2350654-35065491.16792.29
3352119-35211991.54892.68
4349844-34984490.95792.06
5349306-34930690.81791.92
6345416-34541689.80690.91
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