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%
114.941714201713321714501713421712781713640.05
214.951705571707861706720.10
单位质量响应值RSD%判断
11470.1511416.190.34数据可信
中间条件6月-供试品溶液-2025081121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%
30min126654-2665413.90314.303.4313.9014.303.43
226324-2632413.73113.73
327540-2754014.36514.37
428513-2851314.87314.87
526989-2698914.07814.08
628528-2852814.88014.88
60min147762-4776224.91325.053.4224.9425.083.42
247370-4737024.70924.73
348700-4870025.40225.43
450044-5004426.10326.13
545287-4528723.62223.65
648988-4898825.55225.58
120min176109-7610939.69940.253.2839.7640.323.28
276415-7641539.85939.92
379769-7976941.60841.67
479551-7955141.49441.56
573055-7305538.10638.17
678129-7812940.75340.82
240min1114579-11457959.76559.921.9859.9060.061.98
2114067-11406759.49859.63
3116060-11606060.53860.67
4118248-11824861.67961.82
5111393-11139358.10358.23
6114939-11493959.95360.09
360min1143552-14355274.87875.101.2075.1175.331.20
2143113-14311374.64974.88
3143574-14357474.88975.13
4147272-14727276.81877.06
5142302-14230274.22674.45
6144047-14404775.13675.37
480min1160602-16060283.77183.421.1384.1383.781.13
2159235-15923583.05883.41
3159560-15956083.22883.59
4163000-16300085.02285.39
5157551-15755182.18082.53
6159643-15964383.27183.63
600min1169588-16958888.45888.571.0688.9589.071.06
2170761-17076189.07089.56
3168969-16896988.13588.64
4172888-17288890.18090.69
5167781-16778187.51688.00
6168879-16887988.08888.59
720min1176131-17613191.87191.680.9292.5192.320.93
2175402-17540291.49192.13
3175044-17504491.30491.95
4178791-17879193.25993.92
5174181-17418190.85491.48
6175033-17503391.29891.94
960min1182967-18296795.43795.271.1796.2396.061.16
2181713-18171394.78395.58
3181745-18174594.79995.60
4186748-18674897.40998.22
5180878-18087894.34795.13
6181795-18179594.82595.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1187078-18707897.58197.090.9498.5498.040.94
2185624-18562496.82397.77
3185227-18522796.61697.57
4189188-18918898.68299.66
5184427-18442796.19897.14
6185232-18523296.61897.57
1440min1189134-18913498.65498.260.9799.7799.380.97
2187748-18774897.93199.04
3186888-18688897.48298.60
4191717-191717100.001101.14
5187018-18701897.55098.65
6187779-18777997.94799.06
极限1189354-18935498.76898.220.95100.0599.500.95
2187605-18760597.85699.13
3187283-18728397.68898.97
4191331-19133199.800101.11
5186393-18639397.22498.49
6187803-18780397.95999.24
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%
114.941714771713241716581715451716431715290.08
214.951714081714291714180.01
单位质量响应值RSD%判断
11481.1911466.090.10数据可信
中间条件6月-供试品溶液-2025081121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%
30min125139-2513913.07813.533.5313.0813.533.53
226405-2640513.73613.74
325197-2519713.10813.11
427351-2735114.22914.23
526625-2662513.85113.85
625344-2534413.18413.18
60min146473-4647324.17624.542.7024.2024.562.70
248523-4852325.24325.27
345725-4572523.78723.81
448800-4880025.38725.41
547296-4729624.60424.63
646166-4616624.01624.04
120min175985-7598539.52940.101.5139.5940.161.51
278020-7802040.58740.65
377902-7790240.52640.59
478437-7843740.80440.87
576344-7634439.71639.78
675826-7582639.44639.51
240min1114326-11432659.47559.871.1359.6060.001.13
2116008-11600860.35060.48
3112974-11297458.77158.90
4116485-11648560.59860.73
5115807-11580760.24560.38
6114863-11486359.75459.88
360min1142200-14220073.97575.031.3474.2075.261.34
2145172-14517275.52175.75
3141390-14139073.55473.78
4145343-14534375.61075.85
5146033-14603375.96976.20
6145237-14523775.55575.78
480min1158745-15874582.58283.311.2782.9383.661.27
2160663-16066383.58083.94
3156673-15667381.50481.85
4161484-16148484.00784.37
5161691-16169184.11584.47
6161573-16157384.05384.41
600min1168239-16823987.52188.641.2588.0189.141.25
2171164-17116489.04389.54
3167367-16736787.06787.55
4171094-17109489.00689.51
5172815-17281589.90290.40
6171669-17166989.30589.80
720min1173258-17325890.13291.011.3790.7791.651.35
2177974-17797492.58593.23
3174987-17498791.03291.66
4177609-17760992.39693.04
5172233-17223389.59990.25
6173588-17358890.30490.95
960min1181713-18171394.53195.581.2595.3196.371.24
2184823-18482396.14896.95
3180441-18044193.86994.65
4184188-18418895.81896.62
5186751-18675197.15197.95
6184476-18447695.96896.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1184689-18468996.07997.031.1297.0297.981.11
2187828-18782897.71298.67
3183219-18321995.31496.25
4187211-18721197.39198.35
5188421-18842198.02098.98
6187704-18770497.64798.60
1440min1187159-18715997.36498.281.1298.4799.401.12
2189999-18999998.84199.97
3185560-18556096.53297.63
4189499-18949998.58199.71
5191041-19104199.383100.51
6190255-19025598.974100.09
极限1186779-18677997.16698.071.1498.4399.351.13
2189681-18968198.67699.96
3185159-18515996.32397.58
4189081-18908198.36399.65
5190926-19092699.323100.61
6189524-18952498.59499.87
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%
114.941716511714771718081721171716371717380.15
214.951714761713501714130.06
单位质量响应值RSD%判断
11495.1811465.750.19数据可信
中间条件6月-供试品溶液-2025081221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%
30min126382-2638213.71614.052.3013.7214.052.29
227876-2787614.49314.49
327603-2760314.35114.35
427152-2715214.11714.12
526615-2661513.83713.84
626513-2651313.78413.78
60min146181-4618124.01024.572.0924.0324.592.10
248494-4849425.21325.24
348387-4838725.15725.18
446446-4644624.14824.17
546779-4677924.32124.34
647249-4724924.56524.59
120min174835-7483538.90739.281.9438.9739.351.94
278318-7831840.71840.78
376016-7601639.52139.59
474392-7439238.67738.74
574654-7465438.81338.88
675145-7514539.06939.13
240min1116635-11663560.64061.011.4960.7761.141.49
2120453-12045362.62562.76
3117300-11730060.98561.12
4116499-11649960.56960.70
5115353-11535359.97360.10
6117828-11782861.26061.39
360min1142119-14211973.88973.891.0474.1274.121.04
2144648-14464875.20475.44
3141650-14165073.64573.88
4141062-14106273.34073.57
5140455-14045573.02473.25
6142762-14276274.22374.45
480min1158973-15897382.65282.230.9083.0082.580.90
2160050-16005083.21283.58
3157046-15704681.65082.01
4157120-15712081.68882.04
5156592-15659281.41481.76
6159161-15916182.74983.10
600min1169568-16956888.16087.500.7988.6587.990.79
2168853-16885387.78888.29
3167355-16735587.01087.50
4168105-16810587.39987.89
5166285-16628586.45386.94
6169648-16964888.20288.69
720min1175543-17554391.26790.580.7091.9091.220.70
2174756-17475690.85791.51
3173158-17315890.02790.66
4173983-17398390.45691.09
5172548-17254889.70990.34
6175369-17536991.17691.82
960min1183034-18303495.16194.280.9295.9595.060.92
2182110-18211094.68195.48
3179507-17950793.32794.11
4180873-18087394.03894.82
5179420-17942093.28294.06
6183075-18307595.18395.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1187041-18704197.24495.930.8998.1996.880.89
2183757-18375795.53796.50
3183268-18326895.28396.23
4184081-18408195.70696.65
5182928-18292895.10696.04
6185986-18598696.69697.65
1440min1189571-18957198.56097.101.0399.6798.211.02
2185732-18573296.56497.68
3184812-18481296.08697.19
4186399-18639996.91198.01
5185440-18544096.41297.51
6188641-18864198.07699.19
极限1188600-18860098.05597.020.8399.3398.290.83
2186175-18617596.79498.07
3185035-18503596.20297.46
4186613-18661397.02298.28
5185010-18501096.18997.44
6188255-18825597.87699.15
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%
114.941717551716541714901714891709511714680.19
214.951716281714421715350.08
单位质量响应值RSD%判断
11477.1111473.910.02数据可信
中间条件6月-供试品溶液-2025081221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%
30min125239-2523913.12813.994.0013.1313.994.00
226941-2694114.01314.01
327051-2705114.07014.07
428471-2847114.80914.81
526346-2634613.70313.70
627372-2737214.23714.24
60min144488-4448823.14024.403.2823.1624.423.28
247356-4735624.63124.65
346134-4613423.99624.02
449139-4913925.55925.58
547096-4709624.49624.52
647263-4726324.58324.61
120min171997-7199737.44838.722.7937.5138.782.79
275602-7560239.32339.39
373593-7359338.27838.34
477054-7705440.07840.15
572388-7238837.65137.72
675976-7597639.51839.58
240min1112415-11241558.47160.442.4958.5960.582.49
2119561-11956162.18862.32
3116105-11610560.39060.52
4119183-11918361.99162.13
5113533-11353359.05259.18
6116467-11646760.57860.71
360min1138655-13865572.11973.841.7272.3474.071.72
2143841-14384174.81775.05
3141765-14176573.73773.96
4145078-14507875.46075.70
5139775-13977572.70272.93
6142667-14266774.20674.44
480min1155969-15596981.12582.351.6281.4782.701.62
2161345-16134583.92184.28
3158199-15819982.28582.64
4161147-16114783.81884.18
5155181-15518180.71581.06
6158073-15807382.21982.57
600min1166371-16637186.53587.761.5887.0188.241.58
2172098-17209889.51490.01
3168913-16891387.85788.35
4171585-17158589.24789.75
5165745-16574586.21086.69
6167590-16759087.16987.66
720min1173633-17363390.31291.091.4890.9391.721.48
2178465-17846592.82693.47
3175459-17545991.26291.90
4177738-17773892.44893.10
5171923-17192389.42390.05
6173512-17351290.24990.89
960min1181087-18108794.18994.761.4894.9695.551.48
2185566-18556696.51997.32
3182082-18208294.70795.49
4185157-18515796.30697.11
5178802-17880293.00193.77
6180449-18044993.85894.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1184556-18455695.99496.561.4796.9297.501.47
2189727-18972798.68399.65
3185483-18548396.47697.42
4187864-18786497.71498.68
5182301-18230194.82195.75
6183880-18388095.64296.59
1440min1186511-18651197.01197.911.4798.1099.021.47
2192091-19209199.913101.04
3188315-18831597.94999.05
4190936-19093699.312100.44
5185028-18502896.23997.33
6186563-18656397.03898.14
极限1187363-18736397.45497.891.2698.7099.161.27
2191363-19136399.534100.83
3188550-18855098.07199.34
4190357-19035799.011100.31
5185074-18507496.26397.51
6186509-18650997.01098.28
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