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%
114.951722421728031724121721741729071725080.20
214.951723771722631723200.05
单位质量响应值RSD%判断
11539.0011526.420.08数据可信
加速1月-供试品溶液-bc1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%
30min129200-2920015.11314.795.0815.1114.795.09
227851-2785114.41414.41
326985-2698513.96613.97
427135-2713514.04414.04
530231-3023115.64615.65
630083-3008315.57015.57
60min152069-5206926.94926.433.8226.9726.463.82
250548-5054826.16126.19
349860-4986025.80525.83
448484-4848425.09325.12
551274-5127426.53726.56
654159-5415928.03028.06
120min183573-8357343.25443.253.8643.3243.323.86
288124-8812445.60945.68
380542-8054241.68541.75
479740-7974041.27041.33
583191-8319143.05643.13
686233-8623344.63044.70
240min1123858-12385864.10363.531.5464.2563.671.54
2122337-12233763.31663.46
3120335-12033562.28062.42
4121000-12100062.62462.76
5123635-12363563.98864.13
6125328-12532864.86465.01
360min1145793-14579375.45674.930.8675.7075.170.86
2144724-14472474.90375.15
3143116-14311674.07074.31
4143552-14355274.29674.53
5145203-14520375.15075.40
6146244-14624475.68975.94
480min1159821-15982182.71682.250.6183.0982.620.62
2159497-15949782.54882.92
3157331-15733181.42781.79
4158151-15815181.85282.21
5159289-15928982.44182.81
6159398-15939882.49782.88
600min1176225-17622591.20690.910.9191.7291.420.91
2178080-17808092.16692.68
3173390-17339089.73990.24
4174543-17454390.33590.83
5175673-17567390.92091.43
6176030-17603091.10591.62
720min1182063-18206394.22793.690.5694.8994.360.57
2182063-18206394.22794.89
3179561-17956192.93393.58
4180179-18017993.25293.90
5180996-18099693.67594.34
6181344-18134493.85594.53
960min1188296-18829697.45397.360.9798.2898.180.97
2191394-19139499.05799.88
3186450-18645096.49897.30
4186460-18646096.50397.31
5187660-18766097.12497.94
6188411-18841197.51398.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1191240-19124098.97798.710.7199.9699.690.71
2192391-19239199.573100.56
3188631-18863197.62798.59
4189764-18976498.21399.18
5190880-19088098.79199.77
6191475-19147599.099100.09
1440min1192793-19279399.78199.190.85100.93100.330.85
2193859-193859100.333101.49
3189873-18987398.27099.40
4189876-18987698.27199.40
5191205-19120598.959100.10
6192252-19225299.501100.66
极限1191975-19197599.35799.240.74100.67100.550.73
2193025-19302599.901101.22
3189435-18943598.04399.33
4193225-193225100.004101.30
5191902-19190299.320100.63
6190935-19093598.819100.14
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%
114.951714301717931721481719411723811719390.21
214.951715631722531719080.29
单位质量响应值RSD%判断
11500.9411498.860.02数据可信
加速1月-供试品溶液-bc2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%
30min126078-2607813.53514.152.6413.5414.152.63
226950-2695013.98813.99
328013-2801314.54014.54
427952-2795214.50814.51
527155-2715514.09414.09
627417-2741714.23014.23
60min147000-4700024.39425.312.9624.4225.332.96
246936-4693624.36124.38
349478-4947825.68125.70
450317-5031726.11626.14
549705-4970525.79825.82
649151-4915125.51125.53
120min177580-7758040.26641.401.8740.3341.461.87
278653-7865340.82340.89
380955-8095542.01842.09
481357-8135742.22742.29
580726-8072641.89941.97
679294-7929441.15641.22
240min1118945-11894561.73662.161.2061.8762.301.20
2118920-11892061.72361.86
3120581-12058162.58562.72
4122325-12232563.49063.63
5119219-11921961.87862.01
6118589-11858961.55161.69
360min1148527-14852777.09075.161.7377.3275.401.73
2142799-14279974.11774.35
3144522-14452275.01175.25
4146758-14675876.17276.42
5144499-14449974.99975.24
6141739-14173973.56773.80
480min1156565-15656581.26282.681.2881.6283.041.27
2158580-15858082.30882.67
3160486-16048683.29783.66
4162541-16254184.36484.73
5159005-15900582.52882.89
6158587-15858782.31282.67
600min1172759-17275989.66791.271.1990.1691.771.19
2174874-17487490.76591.26
3176693-17669391.70992.21
4179075-17907592.94593.46
5176092-17609291.39791.90
6175628-17562891.15691.65
720min1179064-17906492.94094.691.2193.5995.341.20
2181668-18166894.29194.94
3183514-18351495.24995.91
4185696-18569696.38297.05
5182020-18202094.47495.13
6182654-18265494.80395.45
960min1186482-18648296.79098.411.1697.5999.221.16
2189024-18902498.10998.91
3190700-19070098.97999.80
4193103-193103100.226101.05
5189346-18934698.27699.09
6188969-18896998.08198.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1190210-19021098.72599.830.9699.69100.800.96
2191655-19165599.475100.44
3192362-19236299.842100.82
4195732-195732101.591102.58
5192177-19217799.746100.72
6191870-19187099.586100.56
1440min1190591-19059198.923100.341.16100.05101.481.16
2192085-19208599.698100.83
3193438-193438100.400101.55
4197309-197309102.409103.57
5192929-192929100.136101.28
6193527-193527100.446101.58
极限1190793-19079399.027100.301.28100.32101.611.28
2192478-19247899.902101.20
3192864-192864100.102101.42
4198029-198029102.783104.12
5192694-192694100.014101.32
6192644-19264499.988101.29
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