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%
115.063338663335543337473335813333973336290.06
214.973332623335643334130.07
单位质量响应值RSD%判断
22153.3222272.080.38数据可信
供试品溶液-24101001-1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%
30min138468-3846810.12510.125.0610.1210.125.04
240359-4035910.62310.62
337823-378239.9559.96
438831-3883110.22010.22
535057-350579.2279.23
640232-4023210.58910.59
60min173345-7334519.30518.983.9319.3219.003.94
275073-7507319.75919.78
372234-7223419.01219.03
472629-7262919.11619.13
566711-6671117.55917.57
672660-7266019.12419.14
120min1126343-12634333.25432.004.1433.3032.054.14
2126620-12662033.32733.38
3123727-12372732.56532.61
4120928-12092831.82931.88
5113668-11366829.91829.96
6118275-11827531.13031.18
240min1198427-19842752.22749.764.7552.3349.874.75
2197448-19744851.96952.08
3194463-19446351.18351.29
4186223-18622349.01449.12
5177765-17776546.78846.88
6180106-18010647.40447.51
360min1245465-24546564.60761.464.8064.8061.654.79
2243715-24371564.14664.34
3241179-24117963.47963.67
4227758-22775859.94760.13
5221559-22155958.31558.49
6221486-22148658.29658.48
480min1281039-28103973.97070.984.1374.2771.264.13
2280672-28067273.87474.17
3277139-27713972.94473.24
4262902-26290269.19769.48
5258179-25817967.95368.22
6258078-25807867.92768.20
600min1299284-29928478.77275.893.9079.1976.293.90
2299347-29934778.78979.21
3296670-29667078.08478.50
4280937-28093773.94374.34
5277198-27719872.95973.34
6276458-27645872.76473.16
720min1312511-31251182.25479.413.7082.8179.943.70
2312271-31227182.19182.74
3310603-31060381.75282.30
4293788-29378877.32677.85
5290461-29046176.45076.95
6290566-29056676.47876.99
960min1331410-33141087.22884.553.3587.9285.223.36
2331665-33166587.29587.99
3329958-32995886.84687.53
4313084-31308482.40583.06
5310924-31092481.83682.47
6310433-31043381.70782.35
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1344377-34437790.64187.963.0391.4888.773.04
2343834-34383490.49891.33
3341943-34194390.00090.83
4324511-32451185.41286.20
5324482-32448285.40586.17
6326020-32602085.80986.59
1440min1351812-35181292.59890.072.6693.5991.022.68
2350346-35034692.21293.20
3349216-34921691.91592.89
4333400-33340087.75288.68
5333621-33362187.81088.72
6334791-33479188.11889.04
极限1351701-35170192.56990.172.5893.7191.272.59
2350045-35004592.13393.27
3350038-35003892.13193.26
4335498-33549888.30489.38
5334213-33421387.96689.02
6333990-33399087.90788.97
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%
115.063341963340453343133341253342623341880.04
214.973344093340673342380.08
单位质量响应值RSD%判断
22190.4422327.190.44数据可信
供试品溶液-24101001-2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%
30min136533-365339.5969.934.699.609.934.69
237770-377709.9219.92
335802-358029.4049.40
440973-4097310.76210.76
538003-380039.9829.98
637858-378589.9449.94
60min168140-6814017.89818.161.6417.9118.171.64
269400-6940018.22818.24
367367-6736717.69417.71
469653-6965318.29518.31
570155-7015518.42718.44
670073-7007318.40518.42
120min1115895-11589530.44130.451.1630.4930.491.16
2117074-11707430.75030.80
3113494-11349429.81029.86
4115455-11545530.32530.37
5116670-11667030.64430.69
6116910-11691030.70730.75
240min1181674-18167447.71847.431.0647.8147.531.05
2182369-18236947.90148.00
3177657-17765746.66346.76
4178812-17881246.96647.07
5181150-18115047.58047.68
6181865-18186547.76847.87
360min1224471-22447158.95958.891.5959.1459.071.59
2224963-22496359.08859.27
3219595-21959557.67857.85
4221732-22173258.24058.42
5230100-23010060.43860.62
6224492-22449258.96559.14
480min1259978-25997868.28568.221.1668.5668.501.16
2261722-26172268.74369.02
3254750-25475066.91267.18
4258292-25829267.84268.12
5263468-26346869.20269.48
6260246-26024668.35668.63
600min1278923-27892373.26173.270.9173.6573.660.91
2280256-28025673.61174.00
3274990-27499072.22872.61
4277289-27728972.83273.22
5282170-28217074.11474.51
6280055-28005573.55973.95
720min1292735-29273576.88976.910.8377.4077.420.83
2293842-29384277.18077.69
3289108-28910875.93776.44
4291282-29128276.50877.02
5296141-29614177.78478.30
6293714-29371477.14677.66
960min1310891-31089181.65882.000.9382.3082.640.93
2314348-31434882.56683.21
3308045-30804580.91081.54
4310702-31070281.60882.24
5316095-31609583.02583.67
6313006-31300682.21482.85
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1322796-32279684.78585.390.7685.5686.170.76
2326997-32699785.88886.67
3322429-32242984.68985.45
4323761-32376185.03885.81
5328354-32835486.24587.03
6326337-32633785.71586.49
1440min1329553-32955386.56087.470.8187.4888.390.81
2335287-33528788.06688.99
3330828-33082886.89587.80
4331574-33157487.09188.00
5335557-33555788.13789.07
6335379-33537988.09089.01
极限1330392-33039286.78087.540.8587.8488.600.85
2335751-33575188.18889.26
3330241-33024186.74087.79
4331613-33161387.10188.16
5336187-33618788.30289.38
6335413-33541388.09989.17
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