Name:Afatinib dimaleate
Synonym:
(Z)-but-2-enedioic acid,(E)-N-[4-(3-chloro-4-fluoroanilino)-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide;
AFATINIB DIMALEATE;
Afatinib dimaleate (USAN);
Afatinib maleate;
Gilotrif (TN);
CAS no:850140-73-7
Molecular formula:C32H33ClFN5O11
Molecular weight:718.08300
PSA:241.30000
LogP:4.53600
分析项目 ITEM OF ANALYSIS |
指标 STANDARD |
性状 Appearance |
应为白色至黄色粉末 White to light yellow powder |
HPLC法鉴别 HPLC Identification |
在含量测定项下记录的色谱图中,供 试品溶液主峰的保留时间应与对照品 溶液中主峰的保留时间一致 The retention time of the sample is in accordance with that of reference substance in Assay test chromatogram. |
单一杂质 Individual impurity |
≤0.2% |
总杂质 Total impurities |
≤0.5% |
干燥失重 Loss on drying |
≤1.0% |
炽灼残渣 Residue on ignition |
≤0.1% |
含量(HPLC) |
≥98.5% |
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