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Table 1 Data on the investigational product

From: Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial

Name of active ingredients

Tegafur

Uracil

Description

Tegafur occurs as a white crystalline powder. It is soluble in methanol, sparingly in water and ethanol, and slightly in ether. It is soluble in dilute sodium hydroxide.

Uracil occurs as a white crystal or crystalline powder, free of odor or taste. It is slightly soluble in water; slightly soluble in methanol, ethanol and acetone; and insoluble in ethyl acetate and chloroform.

Structure

Chemical name

1-(2-tetrahydrofuryl)-5-fluorouracid 5-fluoro-1-(2-tetrahydrofuryl)-2,4 (1H,3H)-pyrimidinedione (IUPAC)

2,4(1H,3H)-pyrimidinedione

Molecular formula

C8H9FN2O3

C4H4N2O2

Molecular weight

200.17

112.09

Melting point

166 °C–171 °C

Approximately 335 °C

Contents

Each capsule contains 100 mg tegafur and 224 mg uracil.

Storage condition

Below 30 °C