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%
115.251742701743331748711735111736781741330.32
215.331741491762461751980.85
单位质量响应值RSD%判断
11418.5611428.440.07数据可信
供试品溶液-2025081221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%
30min127229-2722914.22714.157.1714.2314.157.18
227561-2756114.40114.40
330599-3059915.98815.99
426024-2602413.59813.60
525972-2597213.57013.57
625119-2511913.12513.12
60min148515-4851525.34924.534.5425.3724.564.55
246718-4671824.41024.43
350418-5041826.34426.37
444800-4480023.40823.43
545415-4541523.72923.75
645857-4585723.96023.98
120min175951-7595139.68539.113.3139.7539.173.31
275020-7502039.19839.26
379161-7916141.36241.43
472781-7278138.02838.09
572747-7274738.01038.07
673446-7344638.37638.44
240min1112034-11203458.53858.612.4858.6758.742.49
2109813-10981357.37857.51
3117410-11741061.34761.49
4112303-11230358.67958.80
5109877-10987757.41157.54
6111581-11158158.30158.43
360min1135723-13572370.91671.672.4271.1571.902.42
2134532-13453270.29370.52
3143592-14359275.02775.27
4136046-13604671.08471.31
5135422-13542270.75870.98
6137718-13771871.95872.18
480min1152942-15294279.91380.421.5180.2680.771.52
2151519-15151979.16979.51
3158294-15829482.70983.08
4153251-15325180.07480.42
5153257-15325780.07780.42
6154190-15419080.56580.91
600min1164721-16472186.06786.191.0986.5586.671.10
2162810-16281085.06985.54
3168045-16804587.80488.31
4164066-16406685.72586.20
5164315-16431585.85586.33
6165754-16575486.60787.08
720min1170443-17044389.05789.981.2889.6890.601.28
2171380-17138089.54690.16
3176109-17610992.01792.67
4173063-17306390.42691.04
5170150-17015088.90489.52
6172084-17208489.91490.54
960min1180793-18079394.46594.940.6595.2495.710.65
2181481-18148194.82495.59
3183463-18346395.86096.66
4181593-18159394.88395.65
5180259-18025994.18694.95
6182580-18258095.39896.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187151-18715197.78797.830.8798.7298.760.87
2186633-18663397.51698.44
3189491-18949199.00999.97
4185041-18504196.68497.61
5186399-18639997.39498.31
6188708-18870898.60099.53
1440min1191301-19130199.95599.640.76101.05100.740.77
2190758-19075899.671100.76
3193111-193111100.901102.03
4189607-18960799.070100.16
5188950-18895098.72799.81
6190497-19049799.535100.63
极限1193547-193547101.12999.941.19102.39101.201.18
2188934-18893498.71899.97
3193555-193555101.133102.43
4188636-18863698.56399.82
5192657-192657100.664101.91
6190269-19026999.416100.68
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%
115.251748321745881757911728701746961745550.61
215.331739701749851744780.42
单位质量响应值RSD%判断
11446.2311381.470.41数据可信
供试品溶液-2025081221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%
30min128591-2859114.95214.367.1414.9514.367.15
228761-2876115.04015.04
325550-2555013.36113.36
425918-2591813.55413.55
530188-3018815.78715.79
625796-2579613.49013.49
60min147671-4767124.92924.055.3224.9524.085.32
246846-4684624.49824.52
342761-4276122.36222.38
444715-4471523.38423.41
549472-4947225.87125.90
644524-4452423.28423.31
120min175338-7533839.39838.533.6839.4638.603.68
274635-7463539.03039.10
369066-6906636.11836.18
473600-7360038.48938.55
576902-7690240.21640.29
672555-7255537.94238.00
240min1114374-11437459.81258.432.6059.9458.552.60
2111655-11165558.39058.52
3107801-10780156.37456.49
4110413-11041357.74057.87
5115723-11572360.51760.65
6110379-11037957.72257.85
360min1134760-13476070.47271.472.2770.7071.702.27
2138411-13841172.38272.61
3133133-13313369.62269.84
4136403-13640371.33271.55
5141875-14187574.19374.43
6135415-13541570.81571.04
480min1154059-15405980.56580.421.1980.9180.761.19
2153711-15371180.38380.73
3152438-15243879.71780.05
4154564-15456480.82981.17
5156602-15660281.89582.26
6151311-15131179.12879.47
600min1164154-16415485.84486.020.8786.3386.500.88
2165488-16548886.54287.02
3162712-16271285.09085.55
4165724-16572486.66587.14
5165911-16591186.76387.26
6162940-16294085.20985.68
720min1168986-16898688.37189.961.4189.0090.581.40
2174401-17440191.20391.83
3171435-17143589.65290.26
4173860-17386090.92091.54
5174000-17400090.99391.63
6169456-16945688.61789.23
960min1178593-17859393.39595.041.6294.1795.821.62
2183661-18366196.04596.82
3181494-18149494.91295.67
4184273-18427396.36597.14
5184589-18458996.53097.32
6177876-17787693.02093.78
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1185370-18537096.93998.371.5097.8799.301.49
2190627-19062799.688100.63
3190429-19042999.584100.50
4190497-19049799.620100.55
5187360-18736097.97998.93
6184353-18435396.40797.32
1440min1189165-18916598.92399.661.45100.01100.751.44
2194218-194218101.566102.67
3191191-19119199.983101.06
4193231-193231101.050102.15
5187930-18793098.27899.40
6187694-18769498.15499.23
极限1190550-19055099.64899.691.47100.90100.961.46
2194177-194177101.544102.82
3191684-191684100.241101.49
4192488-192488100.661101.93
5188390-18839098.51899.80
6186532-18653297.54698.79
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