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High-Purity 5-Fluorouracil Powder: A Key Pharmaceutical Intermediate for Oncology

5-Fluorouracil (5-FU) stands as a foundational compound within the pharmaceutical landscape, recognized primarily as a crucial antimetabolite and a vital intermediate for the synthesis of various chemotherapeutic agents and other related compounds. As a fluorinated pyrimidine analog, 5-FU exerts its potent effects by interfering with fundamental cellular processes, particularly those involving nucleic acid synthesis and metabolism. Its primary mechanism of action involves inhibiting thymidylate synthetase, a critical enzyme required for the synthesis of thymidine monophosphate (dTMP), a precursor for thymidine triphosphate (dTTP). Depletion of intracellular dTTP pools severely impairs DNA synthesis, hindering the proliferation of rapidly dividing cells, such as cancer cells.


Beyond its direct inhibition of thymidylate synthetase, 5-FU is metabolized intracellularly into various active nucleotides, including fluorodeoxyuridine monophosphate (FdUMP), fluorodeoxyuridine triphosphate (FdUTP), and fluorouridine triphosphate (FUTP). These metabolites can be incorporated into both DNA (as FdUTP) and RNA (as FUTP), leading to further disruption of cellular functions. Incorporation into DNA can cause strand breaks and inhibit DNA replication, while incorporation into RNA can affect RNA processing, protein synthesis, and cell cycle progression. This multi-pronged attack on nucleic acid metabolism makes 5-FU a highly effective cytotoxic agent.


The clinical utility of 5-Fluorouracil is extensive, particularly in the field of oncology. It is a cornerstone in the treatment regimens for a wide spectrum of cancers. These include, but are not limited to, colorectal cancer, breast cancer, gastric cancer, pancreatic cancer, esophageal cancer, head and neck cancers, and certain skin cancers. It is often used alone or in combination with other chemotherapeutic agents, targeted therapies, or radiation therapy to enhance its efficacy and broaden its application range. The specific dosage and administration method depend on the type and stage of cancer being treated, as well as the patient's overall health status.


Beyond its direct application as an antineoplastic drug, 5-Fluorouracil also serves as a critical precursor for the synthesis of other important therapeutic agents, such as flucytosine, an antifungal medication. This highlights its versatility and importance not only as an active pharmaceutical ingredient (API) in its own right but also as a key building block in the production of other life-saving medicines.


Furthermore, the scientific community utilizes 5-FU in various research applications. As an inhibitor of pyrimidine synthesis and nucleic acid metabolism, it is a valuable tool in biochemical studies investigating these pathways. Research applications mentioned include studies related to rice ear differentiation, genetic metabolic measurements, and broader plant growth and development research, showcasing its utility beyond human medicine into fundamental biological investigation.


As a pharmaceutical intermediate and API, the quality and purity of 5-Fluorouracil powder are paramount. Adherence to stringent quality standards is essential to ensure the safety and efficacy of the final drug products. High-purity material minimizes impurities that could potentially lead to adverse effects or reduced therapeutic activity. Standard quality control tests for 5-Fluorouracil powder typically include assessment of its physical appearance (e.g., white powder), purity levels determined by methods like High-Performance Liquid Chromatography (HPLC), and measurements of properties such as mesh size, loss on drying, and ash content. Limits for heavy metals (such as lead, arsenic, and mercury) and microbiological contaminants are also crucial aspects of quality control to ensure the material meets pharmaceutical grade requirements.


Manufacturers and suppliers of pharmaceutical intermediates like 5-Fluorouracil must operate under strict regulatory frameworks, such as Good Manufacturing Practices (GMP), and adhere to quality management systems like ISO 9001. Compliance with pharmacopeial standards, such as those outlined in the United States Pharmacopeia (USP) or the British Pharmacopoeia (BP), further validates the quality and suitability of the material for pharmaceutical use. These certifications provide assurance to drug manufacturers that the intermediate they are sourcing is produced under controlled conditions and meets the necessary quality, safety, and efficacy standards required for human medicine.


The global demand for high-quality 5-Fluorouracil powder remains consistent due to its integral role in cancer therapy and other medical applications. Reliable sourcing is critical for pharmaceutical companies manufacturing oncology drugs. Finding a reputable manufacturer and supplier capable of providing material that consistently meets stringent pharmaceutical grade specifications is a key consideration in the supply chain. Factors such as production capacity, quality control procedures, regulatory compliance, and timely delivery are all important when evaluating potential partners.


For those seeking to buy 5-Fluorouracil powder for pharmaceutical production or research, understanding the required specifications and sourcing from a trusted provider is essential. Information regarding the current price, minimum order quantities, packaging options, and lead times are typically part of the procurement process. Establishing a reliable channel for the purchase of this critical intermediate ensures the continuous production of vital medications and the progress of important research projects. NINGBO INNO PHARMCHEM CO.,LTD. is dedicated to being a reliable partner in the supply chain for high-quality pharmaceutical intermediates like 5-Fluorouracil.

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NINGBO INNO PHARMCHEM CO.,LTD. was established in 2007. It is committed to the R&D, production and sales of raw materials, pharmaceutical intermediates and fine chemicals. We striving to create a high-efficiency and high-quality integrated chemical service platform to better serve domestic and foreign customers.

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WHY CHOSE US?

1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;

2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;

3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).

FAQ

  • A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.

  • A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.

  • A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.

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Address: No.163 Ruiqing Rd.,Ningbo 315000 China
Phone: 86-574-87319282
Fax: 86-574-27912196
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