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%
115.063426873424923424423421433425313424590.06
215.103424133421793422960.05
单位质量响应值RSD%判断
22739.6422668.610.23数据可信
供试品溶液-1236043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%
30min151119-5111913.43913.722.0813.4413.722.09
254051-5405114.21014.21
352073-5207313.69013.69
451139-5113913.44413.44
552114-5211413.70113.70
652575-5257513.82213.82
60min187054-8705422.88623.272.6522.9123.302.65
291817-9181724.13824.16
388540-8854023.27723.30
484941-8494122.33122.35
589619-8961923.56023.58
689221-8922123.45623.48
120min1141171-14117137.11337.572.4237.1737.642.42
2146312-14631238.46538.53
3141164-14116437.11137.17
4137938-13793836.26336.32
5146850-14685038.60638.67
6144118-14411837.88837.95
240min1220631-22063158.00358.021.8958.1358.151.89
2226647-22664759.58459.71
3220103-22010357.86457.99
4213811-21381156.21056.33
5220531-22053157.97758.10
6222543-22254358.50658.63
360min1272676-27267671.68572.091.2371.9072.311.24
2279479-27947973.47473.70
3276201-27620172.61272.83
4269499-26949970.85071.06
5273835-27383571.99072.21
6273683-27368371.95072.17
480min1314816-31481682.76483.781.4883.1084.121.48
2325494-32549485.57185.92
3322772-32277284.85585.20
4313079-31307982.30782.64
5318390-31839083.70384.05
6317446-31744683.45583.80
600min1334490-33449087.93688.611.4188.4189.091.41
2343314-34331490.25690.75
3341893-34189389.88290.36
4330990-33099087.01687.48
5336897-33689788.56989.05
6334732-33473288.00088.48
720min1343150-34315090.21391.091.4990.8491.721.48
2353484-35348492.92993.57
3351471-35147192.40093.03
4340273-34027389.45690.07
5346853-34685391.18691.82
6343648-34364890.34490.97
960min1353538-35353892.94494.281.6293.7295.061.61
2366922-36692296.46297.26
3364236-36423695.75696.54
4352556-35255692.68593.45
5357540-35754093.99694.78
6357009-35700993.85694.64
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1359664-35966494.55495.491.4795.4896.421.47
2369823-36982397.22598.18
3369069-36906997.02797.97
4356482-35648293.71894.64
5363485-36348595.55996.50
6360762-36076294.84395.78
1440min1362780-36278095.37396.351.4396.4697.441.43
2372405-37240597.90499.02
3372656-37265697.97099.08
4359674-35967494.55795.63
5366496-36649696.35097.45
6364926-36492695.93797.03
极限1362644-36264495.33896.251.4796.5897.501.47
2372879-37287998.02899.31
3371881-37188197.76699.04
4359023-35902394.38695.62
5365590-36559096.11297.37
6364630-36463095.86097.11
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%
115.063427473430303432833426703424263428310.10
215.103430773434103432440.07
单位质量响应值RSD%判断
22764.3422731.390.11数据可信
供试品溶液-1236043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%
30min155084-5508414.45313.773.6014.4513.773.60
250844-5084413.34113.34
351234-5123413.44313.44
453457-5345714.02714.03
553848-5384814.12914.13
650490-5049013.24813.25
60min192853-9285324.36423.402.5424.3923.422.54
287035-8703522.83722.86
388461-8846123.21123.23
490986-9098623.87423.90
588126-8812623.12323.15
687604-8760422.98623.01
120min1147453-14745338.69037.591.8438.7537.661.84
2140827-14082736.95237.01
3142697-14269737.44237.50
4145303-14530338.12638.19
5142624-14262437.42337.49
6140749-14074936.93136.99
240min1224761-22476158.97558.141.1059.1058.261.10
2219341-21934157.55357.67
3222207-22220758.30558.43
4223658-22365858.68658.81
5221038-22103857.99858.12
6218537-21853757.34257.46
360min1274836-27483672.11472.021.1972.3472.241.19
2270524-27052470.98371.20
3275787-27578772.36472.58
4276224-27622472.47872.70
5278736-27873673.13773.36
6270740-27074071.03971.26
480min1319666-31966683.87783.551.0784.2283.881.08
2314603-31460382.54982.88
3319526-31952683.84084.18
4321447-32144784.34484.69
5321471-32147184.35184.69
6313712-31371282.31582.65
600min1337741-33774188.62088.301.3589.1188.781.35
2331464-33146486.97387.45
3338852-33885288.91189.39
4340446-34044689.32989.82
5340381-34038189.31289.80
6330246-33024686.65387.13
720min1348946-34894691.56090.901.1692.1991.531.16
2343167-34316790.04390.66
3348038-34803891.32291.95
4348846-34884691.53492.17
5349795-34979591.78392.42
6339817-33981789.16489.78
960min1360655-36065594.63294.031.2295.4294.811.22
2355188-35518893.19893.97
3360914-36091494.70095.48
4360032-36003294.46995.26
5362363-36236395.08095.87
6350999-35099992.09892.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1366732-36673296.22795.481.2197.1796.421.20
2360464-36046494.58295.51
3364091-36409195.53496.47
4366523-36652396.17297.12
5368531-36853196.69997.64
6357028-35702893.68094.60
1440min1369802-36980297.03296.281.0298.1497.381.02
2364424-36442495.62196.70
3366840-36684096.25597.35
4368715-36871596.74797.85
5370916-37091697.32498.43
6360983-36098394.71895.79
极限1369571-36957196.97296.111.0198.2497.361.01
2364173-36417395.55596.80
3366440-36644096.15097.41
4367780-36778096.50297.77
5369609-36960996.98298.25
6360036-36003694.47095.70
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