Description

5-Fluorouracil is a fluorinated pyrimidine analog and a cornerstone antimetabolite in oncology and research. Its primary value lies in its potent inhibition of thymidylate synthase, disrupting DNA and RNA synthesis in rapidly dividing cells. This mechanism makes it a critical raw material for pharmaceutical manufacturing, particularly in chemotherapeutic agents, and an essential tool for biochemical and cancer research. Industries requiring high-purity intermediates for life-saving drugs and advanced laboratory studies rely on a consistent, high-quality supply of this compound.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key active component in injectable and topical formulations for chemotherapy, targeting various carcinomas.
• Oncological Research & Development: A fundamental reference standard and experimental compound for studying cell proliferation, apoptosis, and drug resistance mechanisms.
• Biochemical Synthesis: Serves as a crucial building block or intermediate in the synthesis of more complex nucleoside-based pharmaceuticals and probes.
• Veterinary Medicine: Used in topical treatments for certain neoplastic conditions in animals.
• Dermatology: Formulated in topical creams for the treatment of actinic keratosis and superficial basal cell carcinoma.
• Academic & Clinical Laboratories: Employed as a standard in analytical method development, quality control testing, and pharmacokinetic studies.

Basic Information

Product Name	5-Fluorouracil
CAS No.	51-21-8
Molecular Formula	C4H3FN2O2
Molecular Weight	130.08 g/mol
Synonyms	5-FU; Fluorouracil; 5-Fluoro-2,4(1H,3H)-pyrimidinedione; Adrucil; Carac; Efudex; Fluoro Uracil; Fluroblastin; 5-Fluoropyrimidine-2,4-dione
EINECS	200-085-6

Quality Control

Our 5-Fluorouracil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and microbiological examination, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) detailing purity, identity, and safety parameters are provided with every shipment to guarantee traceability and compliance with cGMP and relevant pharmacopoeial standards (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets Ph. Eur. criteria for non-sterile substances

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.