品 名: 4-[2-(2-氨基-4,7-二氢-4-氧-1H-吡咯[2,3-D]嘧啶-5-基)乙基]苯甲酸;培美酸
Product name: 4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pymol[2,3-d]pyrimodin-5-yl)ethyl]benzoic acid
分子式:C15H14N4O3
Molecular Formula: C15H14N4O3
CAS NO: 137281-39-1
质量标准:
检验项目Item
检验标准 Inspection Standard
外 观 Appearance
类白色或浅粉色或淡黄色或蓝灰色粉末 off-white or light pink or light yellow or bluish grey powder
鉴别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与对照品溶液主峰的保留时间一致
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay
样品的红外吸收图谱与对照品图谱一致
IR absorption spectrum of sample should be consident with spectrum of reference standard
水分 Water
≤ 6.5%
灼烧残渣 Residue on Ignition
≤ 1.0%
重金属Heavy metals
≤ 20ppm
相关杂质 Related compounds
杂质A Impurity A
≤ 0.1%
杂质B Impurity B
杂质C Impurity C
杂质D Impurity D
杂质E Impurity E
杂质F Impurity F
单个杂质Single inpurity
≤ 0.2%
总杂质 Total impurity
残留溶剂
Residual solvents
甲醇 Methanol ≤ 3000ppm
乙醇 Ethanol ≤ 5000ppm
乙腈 Acetonitrile ≤ 410ppm
二氯甲烷 Dichloromethane ≤ 600ppn
乙酸乙酯 Ethyl acrtate ≤ 5000ppm
甲苯 Toluene ≤ 890ppm
二乙胺 Diethylamine ≤ 550ppm
正己烷 Hexane ≤ 290ppm
含量Assay
98.0%~102.0% (按无水物计) ( Calculated on the anhydrous substance )
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