產(chǎn)品名稱（Product Name）:丁卡因（Tetracaine）

批號(hào)（Batch NO.）: 20200228

報(bào)告日期(Report Date) : 20200228

檢驗(yàn)依據(jù)(Inspection basis): USP 36

分析項(xiàng)目

Item of Analysis

標(biāo)準(zhǔn)

Standard

性狀

Description

應(yīng)為白色或淺黃色、蒼白固體

White or light yellow, waxy solid

鑒別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

色析法純度

Chromatographic purity

應(yīng)符合規(guī)定

Conform to standard

干燥失重Loss on drying

≤0.50%

灼燒殘?jiān)?/span>Resiue on ignition

≤0.10%

熔點(diǎn) Melting range

41℃～46℃

溶劑殘留

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%