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%
115.111737201738051740141734191733651736650.16
215.171735261742221738740.29
单位质量响应值RSD%判断
11493.3811461.700.20数据可信
供试品溶液-25030701批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min130203-3020315.70716.412.9015.7116.422.91
232989-3298917.15617.16
331885-3188516.58216.58
431666-3166616.46816.47
531493-3149316.37816.38
631135-3113516.19216.19
60min157394-5739429.84729.421.5229.8729.451.52
257643-5764329.97730.01
356666-5666629.46929.50
455330-5533028.77428.80
556211-5621129.23229.26
656167-5616729.20929.24
120min186977-8697745.23246.852.1245.3146.922.12
292035-9203547.86247.94
391524-9152447.59647.67
488782-8878246.17046.25
590107-9010746.85946.94
691059-9105947.35547.43
240min1132481-13248168.89670.381.1169.0570.541.11
2136368-13636870.91771.08
3136210-13621070.83570.99
4135371-13537170.39970.55
5135168-13516870.29370.45
6136442-13644270.95671.11
360min1159429-15942982.91084.311.4783.1884.581.47
2162516-16251684.51584.79
3161524-16152483.99984.27
4161148-16114883.80484.07
5161612-16161284.04584.32
6166493-16649386.58386.86
480min1180350-18035093.79094.210.4994.1994.620.49
2180285-18028593.75694.17
3182040-18204094.66995.08
4180711-18071193.97794.39
5181170-18117094.21694.63
6182382-18238294.84695.26
600min1187648-18764897.58598.000.7098.1598.570.70
2187099-18709997.29997.87
3188202-18820297.87398.44
4187594-18759497.55798.12
5190266-19026698.94699.51
6189884-18988498.74899.32
720min1190189-19018998.90699.110.5699.6399.840.56
2189268-18926898.42799.16
3190678-19067899.16199.90
4189864-18986498.73799.47
5191133-19113399.397100.13
6192299-192299100.004100.74
960min1190847-19084799.24999.190.47100.14100.090.47
2189605-18960598.60399.50
3190477-19047799.05699.96
4190565-19056599.102100.00
5190539-19053999.08899.99
6192344-192344100.027100.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1191356-19135699.51399.470.37100.57100.540.37
2190678-19067899.161100.22
3191165-19116599.414100.48
4190505-19050599.071100.13
5191510-19151099.593100.66
6192464-192464100.089101.16
1440min1190601-19060199.12198.800.25100.34100.030.24
2190219-19021998.922100.15
3190044-19004498.831100.06
4189211-18921198.39899.62
5189862-18986298.73699.97
6190009-19000998.813100.05
极限1189165-18916598.37498.840.9699.76100.230.94
2188304-18830497.92699.32
3189009-18900998.29399.69
4193433-193433100.593101.98
5190091-19009198.855100.25
6190328-19032898.979100.38
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%
115.111743571737631738101737561743901740150.19
215.171746131740511743320.23
单位质量响应值RSD%判断
11516.5511491.890.16数据可信
供试品溶液-25030701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%
30min124172-2417212.54113.043.1412.5413.043.15
225572-2557213.26813.27
325997-2599713.48813.49
424251-2425112.58212.58
524980-2498012.96112.96
625793-2579313.38213.38
60min144493-4449323.08523.661.9923.1123.691.99
246505-4650524.12824.15
346065-4606523.90023.92
444573-4457323.12623.15
545540-4554023.62823.65
646495-4649524.12324.15
120min173963-7396338.37538.801.5538.4338.861.55
276026-7602639.44539.51
374747-7474738.78138.84
472970-7297037.85937.92
575249-7524939.04239.10
675746-7574639.30039.36
240min1114858-11485859.59359.561.2659.7259.681.26
2116454-11645460.42160.55
3114974-11497459.65359.78
4112113-11211358.16858.29
5115381-11538159.86459.99
6114977-11497759.65459.78
360min1140120-14012072.69972.051.2572.9272.281.25
2140658-14065872.97873.21
3137759-13775971.47471.70
4136082-13608270.60470.82
5138690-13869071.95772.18
6139945-13994572.60972.84
480min1161224-16122483.64982.641.4083.9982.991.40
2161831-16183183.96484.31
3158007-15800781.98082.33
4155733-15573380.80081.14
5159097-15909782.54582.89
6159803-15980382.91283.26
600min1171561-17156189.01287.911.2589.5088.391.25
2171487-17148788.97489.46
3167348-16734886.82687.31
4166605-16660586.44186.91
5169093-16909387.73288.21
6170474-17047488.44888.93
720min1177437-17743792.06191.141.3392.6991.771.33
2178706-17870692.71993.36
3173939-17393990.24690.87
4172239-17223989.36489.98
5175854-17585491.23991.87
6175835-17583591.23091.86
960min1184510-18451095.73094.851.2196.5295.631.21
2186112-18611296.56297.35
3181237-18123794.03294.81
4180092-18009293.43894.20
5182000-18200094.42895.21
6182934-18293494.91395.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1190735-19073598.96097.931.2499.9098.861.24
2192114-19211499.676100.63
3186992-18699297.01897.95
4185976-18597696.49197.41
5187775-18777597.42498.36
6188859-18885997.98798.93
1440min1190578-19057898.87997.841.1699.9998.951.16
2191432-19143299.322100.44
3185932-18593296.46897.56
4186515-18651596.77197.85
5188126-18812697.60798.71
6188924-18892498.02199.13
极限1190437-19043798.80697.731.24100.0899.001.23
2191326-19132699.267100.55
3184833-18483395.89897.15
4187218-18721897.13698.38
5188345-18834597.72098.98
6188041-18804197.56398.83
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%
115.111740131742571738881742041738601740440.11
215.171730461734301732380.16
单位质量响应值RSD%判断
11518.4611419.780.61数据可信
供试品溶液-25030701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%
30min128438-2843814.80014.613.3714.8014.613.37
228499-2849914.83214.83
327918-2791814.52914.53
427083-2708314.09514.09
526999-2699914.05114.05
629485-2948515.34515.34
60min150480-5048026.27126.161.4426.3026.181.44
251451-5145126.77726.80
350043-5004326.04426.07
449453-4945325.73725.76
550499-5049926.28126.30
649649-4964925.83925.86
120min181834-8183442.58942.211.0542.6642.281.05
282343-8234342.85442.92
380296-8029641.78941.86
481267-8126742.29442.36
580509-8050941.90041.97
680402-8040241.84441.91
240min1124858-12485864.98063.581.8865.1263.721.88
2124888-12488864.99665.14
3119447-11944762.16462.30
4120252-12025262.58362.72
5122143-12214363.56763.70
6121443-12144363.20363.34
360min1147970-14797077.00876.551.8577.2676.791.85
2151242-15124278.71178.96
3143421-14342174.64174.88
4144996-14499675.46175.70
5148051-14805177.05177.29
6146834-14683476.41776.66
480min1167543-16754387.19586.721.5987.5787.091.59
2170338-17033888.65089.03
3163036-16303684.84985.21
4164373-16437385.54585.91
5168072-16807287.47087.84
6166449-16644986.62687.00
600min1175347-17534791.25691.101.7791.7891.621.77
2179797-17979793.57294.10
3171383-17138389.19389.70
4172423-17242389.73590.24
5177120-17712092.17992.70
6174266-17426690.69491.21
720min1179933-17993393.64393.841.8994.3294.501.88
2185351-18535196.46397.15
3176606-17660691.91292.57
4176918-17691892.07492.73
5182897-18289795.18695.86
6180116-18011693.73894.40
960min1185207-18520796.38896.381.7697.2297.201.75
2189688-18968898.72099.56
3181256-18125694.33295.14
4182082-18208294.76295.57
5187862-18786297.77098.60
6185015-18501596.28897.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1189565-18956598.65699.152.2399.65100.142.22
2194622-194622101.288102.30
3185858-18585896.72797.69
4186673-18667397.15198.12
5196436-196436102.232103.22
6189939-18993998.85199.83
1440min1189033-18903398.37998.331.9199.5399.481.91
2193955-193955100.941102.12
3184426-18442695.98197.11
4185707-18570796.64897.78
5191883-19188399.862101.03
6188582-18858298.14499.29
极限1189928-18992898.84598.221.53100.1699.531.53
2192600-192600100.235101.58
3185208-18520896.38897.68
4186247-18624796.92998.22
5190914-19091499.358100.69
6187415-18741597.53798.85
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢超君 于 2025-03-17 12:07:14 完成)
生成报告数据部分下载报告(谢超君 于 2025-03-17 12:07:38 完成)
Current page cost:99 ms