乌帕替尼片项目信息
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240402对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
114.632001222007612005632000862002982003660.15
215.022028752029842029300.04
单位质量响应值RSD%判断
13695.5613510.650.97数据可信
供试品溶液-24062401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%
30min126279-2627911.63811.781.6211.6411.781.63
226731-2673111.83811.84
327315-2731512.09712.10
426528-2652811.74811.75
526066-2606611.54411.54
626622-2662211.79011.79
60min146926-4692620.78221.151.3120.8021.171.31
247522-4752221.04621.07
348657-4865721.54821.57
447790-4779021.16421.18
547415-4741520.99821.02
648279-4827921.38121.40
120min176621-7662133.93234.871.5033.9934.921.49
279469-7946935.19435.25
379947-7994735.40535.46
478639-7863934.82634.88
578427-7842734.73234.79
679292-7929235.11535.17
240min1120660-12066053.43653.800.4553.5553.910.45
2122057-12205754.05454.17
3121714-12171453.90254.02
4121108-12110853.63453.75
5121365-12136553.74853.86
6121969-12196954.01554.13
360min1149159-14915966.05766.370.5166.2666.580.51
2150840-15084066.80167.00
3149481-14948166.19966.40
4149142-14914266.04966.25
5149886-14988666.37966.58
6150752-15075266.76266.97
480min1171697-17169776.03876.640.5376.3576.960.53
2174013-17401377.06377.38
3173042-17304276.63376.95
4172330-17233076.31876.63
5173878-17387877.00477.32
6173403-17340376.79377.11
600min1185327-18532782.07482.230.4282.5182.680.42
2187204-18720482.90583.35
3185066-18506681.95882.40
4185258-18525882.04382.48
5185623-18562382.20582.65
6185653-18565382.21882.66
720min1193071-19307185.50485.750.4386.0886.330.43
2194854-19485486.29386.87
3194145-19414585.97986.56
4192515-19251585.25785.83
5193597-19359785.73686.31
6193589-19358985.73386.31
960min1202217-20221789.55490.050.4890.2790.770.48
2204962-20496290.77091.49
3203668-20366890.19790.92
4202485-20248589.67390.39
5203407-20340790.08190.80
6203266-20326690.01890.74
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1207610-20761091.94292.270.5992.8193.140.59
2210685-21068593.30494.18
3207291-20729191.80192.67
4207917-20791792.07892.95
5208502-20850292.33793.21
6208037-20803792.13193.00
1440min1211376-21137693.61093.450.5994.6394.470.59
2213308-21330894.46695.50
3210730-21073093.32494.35
4209832-20983292.92693.95
5210292-21029293.13094.15
6210490-21049093.21894.24
乌帕替尼片项目信息
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240402对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
114.632006502008892007272012422010852009190.13
215.022055232049232052230.21
单位质量响应值RSD%判断
13733.3613663.320.37数据可信
供试品溶液-1231323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%
30min130444-3044413.38813.551.2813.3913.551.28
231199-3119913.72013.72
330410-3041013.37313.37
431368-3136813.79513.79
530716-3071613.50813.51
630709-3070913.50513.50
60min151036-5103622.44423.011.4722.4723.031.46
252473-5247323.07623.10
352318-5231823.00823.03
453414-5341423.49023.51
552138-5213822.92822.95
652527-5252723.10023.12
120min181660-8166035.91137.071.9735.9737.131.97
284249-8424937.05037.11
383264-8326436.61736.68
486357-8635737.97738.04
584957-8495737.36137.42
685292-8529237.50837.57
240min1127488-12748856.06557.081.4356.1857.201.43
2129396-12939656.90457.03
3127902-12790256.24756.37
4132129-13212958.10658.23
5130705-13070557.47957.60
6131144-13114457.67257.80
360min1159304-15930470.05671.231.4670.2771.451.46
2160918-16091870.76670.98
3159514-15951470.14970.36
4164413-16441372.30372.53
5163444-16344471.87772.10
6164297-16429772.25272.47
480min1185115-18511581.40782.411.6281.7482.751.62
2184861-18486181.29581.63
3184335-18433581.06481.40
4191315-19131584.13484.48
5188430-18843082.86583.20
6190328-19032883.69984.04
600min1198734-19873487.39688.121.4787.8688.591.47
2198567-19856787.32387.79
3196838-19683886.56287.03
4204320-20432089.85390.34
5200433-20043388.14388.62
6203393-20339389.44589.92
720min1207133-20713391.09091.661.3891.7092.281.37
2207122-20712291.08591.70
3204424-20442489.89890.51
4211982-21198293.22293.85
5208570-20857091.72292.35
6211380-21138092.95793.59
960min1216591-21659195.24995.641.5296.0196.411.51
2215641-21564194.83195.60
3212896-21289693.62494.39
4221648-22164897.47398.26
5217189-21718995.51296.29
6220860-22086097.12697.91
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1220448-22044896.94596.830.9997.8797.770.99
2219717-21971796.62497.55
3217015-21701595.43596.35
4223666-22366698.36099.31
5219410-21941096.48997.42
6220928-22092897.15698.10
1440min1217499-21749995.64894.831.2596.7395.921.24
2215823-21582394.91196.00
3213191-21319193.75494.83
4219916-21991696.71197.83
5213118-21311893.72294.82
6214265-21426594.22695.33
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