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%
115.001745431751741745041746561746641747080.16
215.031741591742131741860.03
单位质量响应值RSD%判断
11647.2011589.220.36数据可信
供试品溶液-2025032321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%
30min129440-2944015.12514.473.4115.1214.473.39
227903-2790314.33514.34
328852-2885214.82314.82
427127-2712713.93613.94
528557-2855714.67114.67
627075-2707513.91013.91
60min151265-5126526.33725.542.2526.3625.572.25
249446-4944625.40325.43
350940-5094026.17026.20
448936-4893625.14125.16
549192-4919225.27225.30
648547-4854724.94124.96
120min182051-8205142.15441.061.7342.2241.121.73
279235-7923540.70740.77
381213-8121341.72341.79
479472-7947240.82940.89
578820-7882040.49440.56
678752-7875240.45940.52
240min1123656-12365663.52862.151.5963.6762.291.59
2120653-12065361.98562.12
3122827-12282763.10263.24
4120361-12036161.83561.97
5119840-11984061.56861.70
6118520-11852060.88961.02
360min1149618-14961876.86675.451.2677.1175.691.27
2146004-14600475.00975.25
3148523-14852376.30376.55
4146696-14669675.36575.60
5145564-14556474.78375.02
6144788-14478874.38574.62
480min1165948-16594885.25684.011.0985.6384.381.09
2162836-16283683.65784.02
3165429-16542984.98985.36
4163163-16316383.82584.19
5162221-16222183.34183.70
6161546-16154682.99483.35
600min1177780-17778091.33490.520.9391.8591.030.93
2176126-17612690.48490.99
3178471-17847191.68992.20
4175440-17544090.13290.63
5175214-17521490.01690.52
6174169-17416989.47989.98
720min1184220-18422094.64393.591.1495.3194.241.15
2181021-18102192.99993.65
3184491-18449194.78295.45
4182880-18288093.95494.61
5181257-18125793.12093.77
6179120-17912092.02392.67
960min1189656-18965697.43596.461.1298.2697.261.13
2186929-18692996.03496.84
3190552-19055297.89698.72
4186788-18678895.96296.77
5187811-18781196.48897.29
6184750-18475094.91595.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1192158-19215898.72197.761.3999.7198.741.39
2190949-19094998.10099.07
3193916-19391699.624100.61
4189175-18917597.18898.16
5189124-18912497.16298.13
6186425-18642595.77696.73
1440min1194304-19430499.82398.611.87100.9899.751.86
2195065-195065100.214101.35
3196006-196006100.698101.85
4188621-18862196.90498.03
5189767-18976797.49298.62
6187901-18790196.53497.65
极限1192570-19257098.93397.412.29100.2598.722.27
2193099-19309999.204100.50
3194778-194778100.067101.39
4186519-18651995.82497.12
5185667-18566795.38696.68
6185049-18504995.06996.35
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%
115.001761351765441769491777521778831770530.43
215.031738411745281741840.28
单位质量响应值RSD%判断
11803.5311589.091.30数据可信
供试品溶液-2025032321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%
30min128572-2857214.58215.032.7314.5815.032.74
229295-2929514.95114.95
330972-3097215.80715.81
429289-2928914.94814.95
529334-2933414.97114.97
629188-2918814.89614.90
60min150740-5074025.89626.322.2525.9226.352.25
251269-5126926.16626.19
353806-5380627.46027.49
451812-5181226.44326.47
550909-5090925.98226.01
650918-5091825.98626.01
120min181352-8135241.51941.872.1541.5941.942.15
281357-8135741.52141.59
383941-8394142.84042.91
484484-8448443.11743.19
580085-8008540.87240.94
681008-8100841.34341.41
240min1119619-11961961.04861.791.4361.1961.931.43
2121966-12196662.24662.38
3123547-12354763.05363.20
4120816-12081661.65961.80
5118768-11876860.61460.75
6121696-12169662.10862.25
360min1143458-14345873.21574.141.1873.4574.381.18
2145314-14531474.16274.40
3148083-14808375.57575.82
4146265-14626574.64774.89
5143904-14390473.44373.68
6144542-14454273.76874.01
480min1160950-16095082.14283.021.1282.5083.391.12
2162351-16235182.85783.22
3165839-16583984.63785.01
4163690-16369083.54083.91
5161558-16155882.45282.81
6161663-16166382.50682.87
600min1170375-17037586.95287.680.9087.4588.180.91
2170940-17094087.24187.74
3174100-17410088.85389.37
4173119-17311988.35388.86
5171923-17192387.74288.24
6170351-17035186.94087.44
720min1175589-17558989.61390.570.9490.2691.220.94
2176725-17672590.19390.84
3179858-17985891.79292.46
4179073-17907391.39192.05
5177231-17723190.45191.09
6176355-17635590.00490.65
960min1183749-18374993.77894.180.6594.5794.980.66
2183642-18364293.72394.52
3186714-18671495.29196.11
4184965-18496594.39895.21
5184534-18453494.17894.97
6183650-18365093.72794.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1186584-18658495.22595.890.5996.1796.850.59
2187356-18735695.61996.57
3189475-18947596.70097.68
4188760-18876096.33597.30
5188071-18807195.98396.93
6187075-18707595.47596.43
1440min1189005-18900596.46096.920.6297.5798.040.62
2188737-18873796.32397.44
3191595-19159597.78298.92
4191063-19106397.51098.64
5189773-18977396.85297.96
6189232-18923296.57697.69
极限1188260-18826096.08096.820.6597.3598.100.66
2188605-18860596.25697.53
3191536-19153697.75299.05
4190571-19057197.25998.55
5189934-18993496.93498.21
6189342-18934296.63297.90
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%
115.001744821744571741291742521740741742790.11
215.031743541747341745440.16
单位质量响应值RSD%判断
11618.6011613.040.04数据可信
供试品溶液-2025032321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%
30min128857-2885714.82815.081.5714.8315.081.57
229629-2962915.22515.22
329732-2973215.27815.28
429737-2973715.28015.28
528691-2869114.74314.74
629414-2941415.11415.11
60min150096-5009625.74226.143.3025.7726.163.29
250602-5060226.00226.03
350434-5043425.91625.94
450871-5087126.14026.17
549131-4913125.24625.27
654055-5405527.77627.80
120min180447-8044741.33841.200.9141.4141.270.91
279754-7975440.98241.05
379288-7928840.74240.81
481210-8121041.73041.80
579672-7967240.94041.01
680691-8069141.46341.53
240min1116965-11696560.10361.701.5660.2461.841.56
2120664-12066462.00362.14
3119114-11911461.20761.34
4121436-12143662.40062.54
5120048-12004861.68761.82
6122213-12221362.79962.94
360min1146202-14620275.12674.940.7375.3675.180.73
2145397-14539774.71274.95
3143906-14390673.94674.18
4146229-14622975.14075.38
5146841-14684175.45475.69
6146428-14642875.24275.49
480min1161942-16194283.21483.160.3183.5883.520.31
2161801-16180183.14283.51
3161235-16123582.85183.21
4162239-16223983.36783.73
5162472-16247283.48683.85
6161292-16129282.88083.25
600min1176147-17614790.51390.320.4091.0190.830.40
2175210-17521090.03290.54
3175063-17506389.95690.46
4176183-17618390.53291.04
5176788-17678890.84391.35
6175283-17528390.06990.58
720min1182095-18209593.57093.950.8294.2294.600.82
2181658-18165893.34594.00
3182092-18209293.56894.22
4183882-18388294.48895.15
5185389-18538995.26295.92
6181845-18184593.44194.10
960min1188477-18847796.84997.690.7497.6698.500.74
2190699-19069997.99198.80
3189704-18970497.48098.29
4192571-19257198.95399.77
5189382-18938297.31498.13
6189791-18979197.52498.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1190295-19029597.78398.981.2698.7599.951.25
2194409-19440999.897100.87
3194491-19449199.939100.91
4194796-194796100.096101.08
5189116-18911697.17798.15
6192592-19259298.96499.94
1440min1195271-195271100.34098.461.74101.4799.601.72
2194434-19443499.910101.05
3194102-19410299.739100.87
4188964-18896497.09998.25
5187808-18780896.50597.64
6189119-18911997.17998.32
极限1186687-18668795.92997.502.3197.2398.812.28
2192898-19289899.121100.43
3193023-19302399.185100.49
4194920-194920100.160101.47
5184444-18444494.77796.07
6186529-18652995.84897.15
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