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%
115.251728091728641731281728591730561729430.09
215.331722361724241723300.08
单位质量响应值RSD%判断
11340.5211241.360.63数据可信
供试品溶液-2025081121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%
30min127284-2728414.42413.953.2914.4213.943.28
226511-2651114.01514.01
326757-2675714.14514.14
426323-2632313.91613.92
524742-2474213.08013.08
626679-2667914.10414.10
60min147463-4746325.09124.712.4925.1224.732.49
247446-4744625.08225.11
347386-4738625.05025.07
446599-4659924.63424.66
544467-4446723.50723.53
647077-4707724.88724.91
120min176754-7675440.57639.902.1140.6439.962.11
276296-7629640.33440.40
376119-7611940.24040.31
474806-7480639.54639.61
572526-7252638.34138.40
676320-7632040.34640.41
240min1114836-11483660.70860.150.6060.8460.280.61
2113960-11396060.24560.38
3113881-11388160.20360.34
4113027-11302759.75159.88
5113032-11303259.75459.88
6113945-11394560.23760.37
360min1139603-13960373.80172.950.9474.0473.180.94
2139493-13949373.74273.98
3137000-13700072.42572.66
4137329-13732972.59872.83
5136579-13657972.20272.43
6137940-13794072.92173.15
480min1155074-15507481.97981.170.7482.3481.520.74
2154543-15454381.69982.05
3152280-15228080.50280.86
4153801-15380181.30681.66
5152500-15250080.61980.96
6153090-15309080.93081.28
600min1165667-16566787.57986.790.7988.0787.280.79
2165448-16544887.46387.96
3162425-16242585.86586.35
4164597-16459787.01487.50
5163763-16376386.57387.05
6163113-16311386.22986.72
720min1172401-17240191.13990.340.7491.7890.970.74
2172036-17203690.94691.58
3169228-16922889.46290.09
4171370-17137090.59491.23
5170435-17043590.10090.72
6169817-16981789.77390.41
960min1181007-18100795.68994.870.8296.4895.650.82
2180459-18045995.39996.19
3177745-17774593.96494.74
4180060-18006095.18895.97
5179965-17996595.13895.91
6177524-17752493.84794.63
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186526-18652698.60697.740.9099.5698.690.90
2185812-18581298.22999.18
3183037-18303796.76297.70
4186030-18603098.34499.29
5185366-18536697.99398.93
6182600-18260096.53197.47
1440min1191454-191454101.21199.471.22102.33100.571.22
2188871-18887199.846100.96
3186230-18623098.45099.55
4189328-189328100.088101.19
5188029-18802999.401100.50
6185016-18501697.80898.91
极限1189092-18909299.96399.310.78101.25100.580.78
2188616-18861699.711100.99
3186604-18660498.64899.91
4189136-18913699.986101.26
5188119-18811999.448100.71
6185572-18557298.10299.36
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%
115.251728511728621729171728961728261728700.03
215.331723401723711723560.02
单位质量响应值RSD%判断
11335.7411243.050.59数据可信
供试品溶液-2025081121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%
30min126539-2653914.03213.734.8714.0313.734.87
225697-2569713.58613.59
326998-2699814.27414.27
426890-2689014.21714.22
526091-2609113.79513.79
623590-2359012.47212.47
60min146515-4651524.59324.295.3324.6224.325.34
245786-4578624.20824.23
347932-4793225.34225.37
444007-4400723.26723.29
549011-4901125.91325.94
642411-4241122.42322.44
120min175130-7513039.72339.153.1739.7939.213.18
274294-7429439.28139.34
376898-7689840.65740.72
472414-7241438.28738.35
575239-7523939.78039.85
670294-7029437.16637.22
240min1112318-11231859.38458.972.6159.5259.102.61
2111446-11144658.92359.05
3115014-11501460.81060.94
4111142-11114258.76358.89
5112949-11294959.71859.85
6106309-10630956.20756.33
360min1135466-13546671.62371.442.0171.8571.672.02
2134995-13499571.37471.60
3138709-13870973.33873.57
4133687-13368770.68370.91
5137026-13702672.44872.68
6130859-13085969.18769.40
480min1150621-15062179.63679.781.4379.9880.131.44
2150936-15093679.80380.15
3153957-15395781.40081.76
4149994-14999479.30479.65
5152288-15228880.51780.87
6147583-14758378.03078.36
600min1161522-16152285.40085.390.9785.8885.870.98
2161367-16136785.31885.80
3163271-16327186.32486.82
4160441-16044184.82885.30
5163168-16316886.27086.76
6159235-15923584.19084.65
720min1168042-16804288.84789.000.9289.4789.620.93
2167974-16797488.81189.43
3170295-17029590.03890.67
4167931-16793188.78889.40
5169807-16980789.78090.41
6165995-16599587.76488.36
960min1176612-17661293.37893.540.5894.1594.310.59
2176522-17652293.33094.10
3178300-17830094.27095.06
4176293-17629393.20993.97
5178041-17804194.13394.91
6175777-17577792.93693.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1182561-18256196.52397.171.2697.4598.091.26
2181940-18194096.19597.12
3187922-18792299.358100.30
4182097-18209796.27897.20
5183147-18314796.83397.77
6185021-18502197.82498.72
1440min1185144-18514497.88998.130.3798.9899.210.38
2185054-18505497.84198.93
3186420-18642098.56499.67
4185284-18528497.96399.04
5186503-18650398.60799.71
6185148-18514897.89198.95
极限1185086-18508697.85897.930.3699.1199.180.37
2184451-18445197.52298.77
3186274-18627498.48699.76
4184733-18473397.67298.91
5185642-18564298.15299.42
6185178-18517897.90799.13
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