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(yàn)項(xiàng)目Item

檢驗(yàn)標(biāo)準(zhǔn)      Inspection Standard

外  觀 Appearance

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

鑒別Identification

在含量測(cè)定項(xiàng)下記錄的色譜圖中，供試品溶液主峰的保留時(shí)間與對(duì)照品溶液主峰的保留時(shí)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?qǐng)D譜與對(duì)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?jiān)?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(gè)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(wú)水物計(jì)) ( Calculated on the anhydrous substance )