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

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

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

≤ 0.1%

杂质C  Impurity C

≤ 0.1%

杂质D  Impurity D

≤ 0.1%

杂质E  Impurity E

≤ 0.1%

杂质F  Impurity F

≤ 0.1%

单个杂质Single inpurity

≤ 0.2%

总杂质 Total impurity

≤ 1.0%

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 )