品 名： 4-[2-(2-氨基-4,7-二氫-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

檢驗項目Item

檢驗標準      Inspection Standard

外  觀 Appearance

類白色或淺粉色或淡黃色或藍灰色粉末  off-white or light pink or light yellow or bluish grey powder

鑒別Identification

在含量測定項下記錄的色譜圖中，供試品溶液主峰的保留時間與對照品溶液主峰的保留時間一致

The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay

樣品的紅外吸收圖譜與對照品圖譜一致

IR absorption spectrum of sample should be consident with spectrum of reference standard

水分   Water

≤ 6.5%

灼燒殘渣 Residue on Ignition

≤ 1.0%

重金屬Heavy metals

≤  20ppm

相關(guān)雜質(zhì) Related compounds

雜質(zhì)A  Impurity A

≤ 0.1%

雜質(zhì)B  Impurity B

≤ 0.1%

雜質(zhì)C  Impurity C

≤ 0.1%

雜質(zhì)D  Impurity D

≤ 0.1%

雜質(zhì)E  Impurity E

≤ 0.1%

雜質(zhì)F  Impurity F

≤ 0.1%

單個雜質(zhì)Single inpurity

≤ 0.2%

總雜質(zhì) Total impurity

≤ 1.0%

殘留溶劑

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% (按無水物計) ( Calculated on the anhydrous substance )