苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.651908341905391909191911471911071909090.13
219.751913311914761914040.06
单位质量响应值RSD%判断
9715.479691.340.18数据可信
加速6月-供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20250420211193363-193363101.79100.771.9998.67%～102.87%
2195490-195490102.91
3195268-195268102.79
4188485-18848599.22
5189500-18950099.76
6186422-18642298.14
20250421211190799-190799100.4498.361.7596.56%～100.16%
2186532-18653298.19
3183639-18363996.67
4188623-18862399.30
5182480-18248096.06
6188997-18899799.49
20250422211186009-18600997.9299.471.1398.30%～100.64%
2192165-192165101.16
3190092-190092100.07
4189168-18916899.58
5188786-18878699.38
6187511-18751198.71
YBA2319批1192801-192801101.49101.540.63100.87%～102.20%
2194016-194016102.13
3192215-192215101.19
4191844-191844100.99
5194666-194666102.48
6191734-191734100.93
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.659505795014945799493395252949670.26
219.759481694162944890.49
单位质量响应值RSD%判断
4832.934784.250.72数据可信
加速6月-供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025042021197794-97794103.89102.021.32100.61%～103.43%
295020-95020100.94
395683-95683101.64
496526-96526102.54
594363-94363100.24
696852-96852102.89
2025042121194815-94815100.72101.322.7698.39%～104.24%
292331-9233198.08
395008-95008100.93
498979-98979105.15
593136-9313698.94
697965-97965104.07
2025042221193711-9371199.55101.012.1098.79%～103.23%
293625-9362599.46
395847-95847101.82
498780-98780104.93
594610-94610100.50
693940-9394099.79
YBA2319批197180-97180103.24103.991.43102.44%～105.55%
296494-96494102.51
397437-97437103.51
4100068-100068106.30
599156-99156105.33
697018-97018103.06
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