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%
114.941724961725731725291729361726421726350.11
214.951720151722031721090.08
单位质量响应值RSD%判断
11555.2211512.310.27数据可信
加速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%
30min124386-2438612.62012.867.1312.6212.867.14
226964-2696413.95413.95
323654-2365412.24112.24
424424-2442412.64012.64
522654-2265411.72411.72
626988-2698813.96713.97
60min145373-4537323.48124.352.7523.5024.372.76
248741-4874125.22425.25
346967-4696724.30624.33
447501-4750124.58224.60
545785-4578523.69423.71
647971-4797124.82524.85
120min177622-7762240.17041.181.5040.2341.241.49
280820-8082041.82541.89
379688-7968841.23941.30
478769-7876940.76440.83
580107-8010741.45641.52
680423-8042341.62041.68
240min1118834-11883461.49862.090.7361.6262.220.73
2121167-12116762.70562.84
3120736-12073662.48262.61
4119705-11970561.94862.08
5119357-11935761.76861.90
6120128-12012862.16762.30
360min1142901-14290173.95274.880.7374.1875.110.73
2144617-14461774.84175.08
3146112-14611275.61475.85
4144736-14473674.90275.14
5145146-14514675.11475.35
6144600-14460074.83275.07
480min1160012-16001282.80882.860.6483.1683.210.64
2160229-16022982.92083.28
3161789-16178983.72784.09
4160086-16008682.84683.20
5158595-15859582.07482.43
6159922-15992282.76183.12
600min1172952-17295289.50489.810.3590.0090.310.35
2174101-17410190.09990.60
3174419-17441990.26390.76
4173571-17357189.82490.32
5173125-17312589.59490.09
6173078-17307889.56990.07
720min1179329-17932992.80492.710.5793.4493.350.57
2179321-17932192.80093.45
3180831-18083193.58294.23
4178996-17899692.63293.28
5177736-17773691.98092.62
6178636-17863692.44693.10
960min1185950-18595096.23196.250.5797.0397.050.57
2185538-18553896.01796.82
3187426-18742696.99597.80
4187103-18710396.82797.63
5184922-18492295.69996.49
6185011-18501195.74596.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1189231-18923197.92997.780.5598.8898.750.55
2188639-18863997.62298.59
3190273-19027398.46899.44
4189700-18970098.17199.13
5187331-18733196.94597.90
6188547-18854797.57598.54
1440min1190074-19007498.36598.230.5599.4899.360.54
2189721-18972198.18299.31
3191303-19130399.001100.13
4190401-19040198.53499.66
5188354-18835497.47598.59
6189081-18908197.85198.98
极限1189895-18989598.27298.120.6399.5599.400.62
2188921-18892197.76899.06
3191252-19125298.975100.27
4190465-19046598.56799.86
5187983-18798397.28398.56
6189049-18904997.83499.12
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%
114.941723401718071719821718581719611719900.13
214.951725331723911724620.06
单位质量响应值RSD%判断
11512.0511535.920.15数据可信
加速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%
30min128726-2872614.87913.148.6214.8813.148.62
227307-2730714.14414.14
324232-2423212.55112.55
425063-2506312.98112.98
523497-2349712.17012.17
623379-2337912.10912.11
60min152386-5238627.13324.606.1327.1624.626.13
249059-4905925.41025.43
347212-4721224.45324.47
444634-4463423.11823.14
544814-4481423.21123.23
646815-4681524.24824.27
120min183023-8302343.00141.272.8043.0741.332.80
281302-8130242.11042.18
379271-7927141.05841.12
478029-7802940.41540.48
576850-7685039.80439.86
679566-7956641.21141.27
240min1121927-12192763.15261.891.7863.2962.021.78
2120265-12026562.29162.43
3120388-12038862.35562.48
4117947-11794761.09061.22
5116038-11603860.10160.23
6120348-12034862.33462.46
360min1145134-14513475.17274.761.7975.4275.001.79
2143913-14391374.53974.78
3147301-14730176.29476.53
4141808-14180873.44973.68
5141030-14103073.04673.27
6146848-14684876.05976.29
480min1159955-15995582.84882.451.0683.2282.811.07
2159512-15951282.61982.98
3161711-16171183.75884.12
4157392-15739281.52181.87
5157206-15720681.42481.77
6159323-15932382.52182.88
600min1173267-17326789.74389.270.9390.2589.770.93
2172732-17273289.46689.97
3174815-17481590.54591.05
4170463-17046388.29188.78
5171093-17109388.61789.10
6171735-17173588.95089.45
720min1179210-17921092.82192.480.8393.4893.130.83
2178558-17855892.48393.13
3181108-18110893.80494.46
4177000-17700091.67792.31
5177769-17776992.07592.71
6177693-17769392.03592.68
960min1185549-18554996.10495.740.9096.9296.540.90
2184881-18488195.75896.56
3187552-18755297.14297.95
4183398-18339894.99095.78
5184803-18480395.71896.50
6182929-18292994.74795.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1188056-18805697.40397.050.8698.3898.010.86
2187665-18766597.20098.17
3189783-18978398.29799.27
4186122-18612296.40197.35
5187459-18745997.09498.04
6185182-18518295.91496.87
1440min1189030-18903097.90797.610.8999.0498.730.88
2188369-18836997.56598.69
3190671-19067198.75799.89
4186652-18665296.67697.78
5189558-18955898.18199.29
6186441-18644196.56697.68
极限1188703-18870397.73897.511.0299.0498.801.01
2188189-18818997.47298.76
3191203-19120399.033100.33
4186143-18614396.41297.68
5189109-18910997.94899.22
6186249-18624996.46797.74
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%
114.941722971721821719501724181717941721280.15
214.951718671719491719080.04
单位质量响应值RSD%判断
11521.2911498.860.14数据可信
加速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%
30min125897-2589713.42913.423.4913.4313.423.49
224740-2474012.82912.83
325773-2577313.36513.37
425048-2504812.98912.99
526765-2676513.88013.88
627008-2700814.00614.01
60min146685-4668524.21024.042.7224.2324.062.72
245206-4520623.44323.46
345583-4558323.63823.66
445100-4510023.38823.41
547515-4751524.64024.66
648085-4808524.93624.96
120min177067-7706739.96539.942.0640.0340.002.07
276577-7657739.71139.77
376390-7639039.61439.68
474887-7488738.83438.89
577458-7745840.16840.23
679704-7970441.33241.40
240min1116126-11612660.22060.191.2560.3560.321.24
2115148-11514859.71359.84
3116518-11651860.42360.55
4114143-11414359.19159.32
5116056-11605660.18360.31
6118437-11843761.41861.55
360min1140817-14081773.02473.070.7973.2573.300.79
2139362-13936272.26972.50
3141833-14183373.55173.78
4139880-13988072.53872.76
5141493-14149373.37473.61
6142094-14209473.68673.92
480min1156881-15688181.35481.700.6881.7182.050.68
2156451-15645181.13181.48
3159147-15914782.52982.88
4156683-15668381.25181.60
5158363-15836382.12382.48
6157742-15774281.80182.16
600min1170498-17049888.41688.880.8488.9089.360.84
2169522-16952287.90988.39
3173328-17332889.88390.37
4170735-17073588.53889.02
5172697-17269789.55690.05
6171527-17152788.94989.44
720min1177755-17775592.17992.200.9492.8192.840.94
2175544-17554491.03291.66
3180035-18003593.36194.00
4176895-17689591.73392.36
5179376-17937693.01993.66
6177168-17716891.87492.52
960min1186459-18645996.69296.051.0297.4896.841.02
2182248-18224894.50995.29
3186652-18665296.79397.59
4184119-18411995.47996.26
5187155-18715597.05397.85
6184633-18463395.74696.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1187145-18714597.04897.390.8098.0098.340.80
2186077-18607796.49497.43
3189531-18953198.28699.24
4187005-18700596.97697.92
5189759-18975998.40499.36
6187308-18730897.13398.09
1440min1187961-18796197.47198.031.0098.5899.141.00
2187120-18712097.03598.13
3190821-19082198.954100.07
4188409-18840997.70498.81
5191911-19191199.520100.64
6187992-18799297.48798.61
极限1187746-18774697.36097.970.9798.6399.240.96
2186836-18683696.88898.15
3190984-19098499.039100.32
4188677-18867797.84399.11
5191298-19129899.202100.49
6187985-18798597.48498.76
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%
114.941723411722551719211723561722121722170.11
214.951720131720421720280.02
单位质量响应值RSD%判断
11527.2411506.890.13数据可信
加速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%
30min126436-2643613.70113.574.9413.7013.574.93
223710-2371012.28812.29
326098-2609813.52513.53
427059-2705914.02414.02
526426-2642613.69513.70
627335-2733514.16714.17
60min147673-4767324.70724.503.5324.7324.523.54
244926-4492623.28323.30
346957-4695724.33624.36
445976-4597623.82723.85
549142-4914225.46825.49
648995-4899525.39225.42
120min179914-7991441.41640.383.0541.4840.443.05
274627-7462738.67638.74
376787-7678739.79539.86
476358-7635839.57339.64
578963-7896340.92340.99
680841-8084141.89641.96
240min1117587-11758760.94060.192.4361.0760.322.43
2112243-11224358.17158.29
3116165-11616560.20360.33
4113748-11374858.95159.08
5117007-11700760.64060.77
6120127-12012762.25762.39
360min1141718-14171873.44673.131.5873.6873.361.58
2139219-13921972.15172.37
3140722-14072272.93073.16
4138667-13866771.86572.09
5141431-14143173.29873.53
6144916-14491675.10475.34
480min1158159-15815981.96781.462.0782.3281.822.07
2153047-15304779.31879.66
3157348-15734881.54781.90
4154157-15415779.89380.24
5158335-15833582.05882.41
6162095-16209584.00784.37
600min1170964-17096488.60388.722.0289.1089.202.02
2167666-16766686.89487.37
3171569-17156988.91789.40
4167992-16799287.06387.54
5171666-17166688.96789.46
6177227-17722791.84992.35
720min1176519-17651991.48291.811.8192.1292.441.81
2173486-17348689.91090.53
3177561-17756192.02292.66
4174514-17451490.44391.07
5178287-17828792.39993.04
6182528-18252894.59695.25
960min1182952-18295294.81695.622.0695.6196.412.06
2180329-18032993.45794.22
3185288-18528896.02796.82
4181981-18198194.31395.09
5185264-18526496.01496.81
6191193-19119399.08799.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1186008-18600896.40096.981.9597.3597.931.95
2182501-18250194.58295.51
3187649-18764997.25098.20
4185080-18508095.91996.85
5188199-18819997.53698.49
6193296-193296100.177101.16
1440min1187338-18733897.08997.912.0298.2099.022.02
2184209-18420995.46896.55
3189509-18950998.21499.33
4186971-18697196.89997.99
5190081-19008198.51199.63
6195427-195427101.281102.43
极限1187423-18742397.13397.881.9998.4199.161.99
2183997-18399795.35896.60
3189055-18905597.97999.25
4187478-18747897.16298.42
5189947-18994798.44199.72
6195307-195307101.219102.54
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