洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481122737112660011251381122492112005711234050.23
213.521129651112940111295260.02
单位质量响应值RSD%判断
83338.6583544.820.18数据可信
长期6月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211129684212833461290094101.46100.001.5598.37%~101.62%
2130288012940731298476102.12
312463961250754124857598.20
412767531257328126704099.65
512734881268647127106899.97
612542331252592125341298.58
2024030221112589151248152125353498.5999.381.3997.94%~100.82%
212607911263827126230999.28
3127762712760251276826100.42
4129075712919741291366101.56
512380601250064124406297.84
612543411252727125353498.59
20240303211134999213470001348496106.06103.422.39100.83%~106.00%
2128426812872811285774101.12
3135110513543471352726106.39
4129507112925411293806101.76
5128575912819581283858100.97
6132647013231091324790104.19
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481125377112627811256611127818112517811260620.10
213.521126381111948411229320.44
单位质量响应值RSD%判断
83535.7683057.100.41数据可信
加速6月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211127944412814391280442100.88100.960.33100.61%~101.30%
2128527812810101283144101.09
3128820112888241288512101.52
4127823112822341280232100.86
5127657112835831280077100.85
6127669912753731276036100.53
2024030221112361601237150123665597.4398.281.2596.99%~99.56%
212345051233066123378697.20
312563191250447125338398.75
412638621265372126461799.63
512657421264060126490199.66
612317891230350123107096.99
2024030321112557111252779125424598.82102.114.5097.29%~106.92%
212552161256837125602698.96
3131873813167111317724103.82
4131055913185171314538103.57
512408711238136123950497.65
6139310813947221393915109.82
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.481121584112090711201751122038112068011210770.07
213.521120081111422111171510.38
单位质量响应值RSD%判断
83165.9582629.510.46数据可信
中间条件6月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211129161312927371292175102.2999.092.3096.70%~101.48%
212464101246994124670298.69
312619181252329125712499.52
4127193512732721272604100.75
512267011229324122801297.22
612130011214428121371496.08
2024030221112508721239576124522498.5898.152.3195.78%~100.53%
2127516612722141273690100.83
312287501228976122886397.28
412135871215475121453196.15
512056511205882120576695.45
6127155112708131271182100.63
20240303211134287013357761339323106.03103.362.23100.94%~105.77%
2129696212980071297484102.71
3127974412776101278677101.23
4129369412888061291250102.22
5134284713464021344624106.45
6128307912808241281952101.49
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