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%
114.941709351710091708241708331702711707740.18
214.851717571711791714680.24
单位质量响应值RSD%判断
11430.6611546.670.72数据可信
影响因素30天-供试品溶液-2025081321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%
30min125189-2518913.08713.462.5213.0913.462.50
225972-2597213.49413.49
325535-2553513.26713.27
425544-2554413.27113.27
527029-2702914.04314.04
626172-2617213.59813.60
60min144697-4469723.22223.842.5323.2423.872.55
246853-4685324.34324.37
344847-4484723.30023.32
445429-4542923.60323.62
547642-4764224.75224.78
645893-4589323.84423.87
120min172570-7257037.70438.301.6337.7638.361.64
275100-7510039.01839.08
372164-7216437.49337.55
473399-7339938.13538.20
574796-7479638.86038.93
674224-7422438.56338.63
240min1110473-11047357.39658.041.3157.5258.161.31
2113974-11397459.21559.34
3109869-10986957.08357.21
4111827-11182758.10058.22
5112493-11249358.44658.58
6111613-11161357.98958.12
360min1135601-13560170.45270.790.8570.6771.010.85
2138438-13843871.92672.15
3135405-13540570.35070.57
4136405-13640570.86971.09
5135392-13539270.34370.57
6136264-13626470.79671.02
480min1155344-15534480.70980.970.7881.0581.310.78
2157933-15793382.05482.40
3155295-15529580.68481.02
4155391-15539180.73481.07
5154575-15457580.31080.65
6156584-15658481.35381.69
600min1165928-16592886.20886.840.8786.6887.320.86
2168243-16824387.41187.89
3169176-16917687.89688.37
4165664-16566486.07186.55
5166118-16611886.30786.78
6167736-16773687.14887.62
720min1173271-17327190.02389.900.5990.6490.520.59
2174683-17468390.75791.39
3172531-17253189.63990.26
4172187-17218789.46090.08
5172002-17200289.36489.99
6173537-17353790.16190.78
960min1179434-17943493.22593.390.5493.9994.160.54
2180628-18062893.84694.63
3179451-17945193.23494.00
4178899-17889992.94793.71
5178858-17885892.92693.70
6181238-18123894.16294.93
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184277-18427795.74195.240.6696.6696.160.66
2184540-18454095.87896.81
3182847-18284794.99895.92
4182281-18228194.70495.63
5181673-18167394.38895.31
6184216-18421695.71096.64
1440min1185875-18587596.57296.160.6197.6597.240.61
2185884-18588496.57697.67
3184674-18467495.94897.03
4184426-18442695.81996.90
5183342-18334295.25696.34
6186273-18627396.77897.87
极限1184680-18468095.95196.020.5197.1997.260.51
2184868-18486896.04897.31
3185311-18531196.27997.52
4184001-18400195.59896.84
5183718-18371895.45196.69
6186290-18629096.78798.04
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%
114.941710291712531711071713111714051712210.09
214.851719831718341719080.07
单位质量响应值RSD%判断
11460.5811576.300.72数据可信
影响因素30天-供试品溶液-1276525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%
30min124362-2436212.62512.284.1512.6212.284.16
221753-2175311.27311.27
323623-2362312.24212.24
424045-2404512.46012.46
524227-2422712.55512.55
624152-2415212.51612.52
60min141657-4165721.58721.385.9821.6121.405.98
237040-3704019.19419.21
341210-4121021.35521.38
440789-4078921.13721.16
542275-4227521.90721.93
644595-4459523.11023.13
120min168987-6898735.75035.024.2235.8135.074.22
262005-6200532.13232.18
369846-6984636.19536.25
467485-6748534.97135.03
569043-6904335.77935.84
668049-6804935.26435.32
240min1107534-10753455.72554.803.2955.8454.923.29
299565-9956551.59551.70
3105920-10592054.88955.00
4106638-10663855.26155.37
5109937-10993756.97057.09
6104919-10491954.37054.49
360min1134755-13475569.83168.152.7070.0468.362.71
2124611-12461164.57464.76
3132589-13258968.70968.92
4132955-13295568.89869.10
5132732-13273268.78368.99
6131457-13145768.12268.33
480min1155493-15549380.57879.371.3380.9079.691.33
2149724-14972477.58877.89
3153103-15310379.33979.66
4154819-15481980.22980.55
5152528-15252879.04179.37
6153345-15334579.46579.79
600min1166754-16675486.41385.421.0786.8785.881.07
2162524-16252484.22184.65
3164068-16406885.02185.48
4166046-16604686.04686.50
5163388-16338884.66985.13
6166293-16629386.17486.63
720min1173139-17313989.72288.790.9990.3389.390.99
2170654-17065488.43489.00
3170430-17043088.31888.91
4173276-17327689.79390.39
5168904-16890487.52788.13
6171667-17166788.95989.56
960min1179297-17929792.91392.420.9893.6793.160.97
2180088-18008893.32394.04
3177247-17724791.85192.59
4179063-17906392.79293.54
5175354-17535490.87091.62
6179045-17904592.78393.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1183033-18303394.84994.271.2795.7695.171.26
2183865-18386595.28096.15
3180086-18008693.32294.22
4183213-18321394.94395.85
5178069-17806992.27793.17
6183244-18324494.95995.86
1440min1183951-18395195.32594.951.4596.3996.001.43
2186440-18644096.61597.64
3181393-18139393.99995.05
4184526-18452695.62396.68
5178964-17896492.74193.79
6184109-18410995.40796.47
极限1183777-18377795.23594.861.2296.4696.071.20
2185907-18590796.33997.53
3181539-18153994.07595.28
4183668-18366895.17896.40
5179529-17952993.03394.24
6183926-18392695.31296.53
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