产品名称（Product Name）:丁卡因（Tetracaine）

批号（Batch NO.）: 20200228

报告日期(Report Date) : 20200228

检验依据(Inspection basis): USP 36

分析项目

Item of Analysis

标准

Standard

性状

Description

应为白色或浅黄色、苍白固体

White or light yellow, waxy solid

鉴别Identification

A. Dissolve 100 mg in 10 mL of dilut hydrochloric acid(1 in 120),and add 1 mL of potassium thiocyanate

solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate

from water, and dry at 80 for 2 hours: it melts between 130 and 132 .

B:  By UV, To match with working standard

色析法纯度

Chromatographic purity

应符合规定

Conform to standard

干燥失重Loss on drying

≤0.50%

灼烧残渣Resiue on ignition

≤0.10%

熔点 Melting range

41℃～46℃

溶剂残留

Ethanol≤0.5%

Acetone≤0.5%

4-Methyl-2-pentanone≤0.5%

DCM≤0.06%

PETROLEUM ETHER≤0.5%

Isopropyl ether≤0.5%

含量Assay

99.0%～101.0%