High Purity 5 Bromouracil for Drug Intermediates Applications

5-Bromouracil is a crucial drug intermediate widely applied in pharmaceutical synthesis, especially as an antineoplastic and antiviral building block. This article provides a comprehensive analysis of 5 bromouracil’s technical parameters, up-to-date industry trends, comparative manufacturer data, custom solutions, and application case studies, offering deep insights for R&D professionals and procurement managers alike.

1. Industry Trends: The Evolving Role of 5 Bromouracil in Drug Intermediates

The drug intermediates sector has witnessed sustained growth, with heterocyclic building blocks like 5 bromouracil gaining global demand owing to their role in synthesizing sophisticated pharmaceutical actives. According to Grand View Research, the pharmaceutical intermediates market size exceeded USD 30.6 billion in 2023 and is projected to register a CAGR of 6.2% from 2024 to 2030. Highly pure, low-residue intermediates such as 5-Bromouracil are increasingly pivotal for advanced API manufacturers and research facilities targeting nucleic acid modulation and cancer therapies.

Key Market Trends:

• Rising demand for pyrimidine analogues in novel drug synthesis
• Emphasis on stringent quality and regulatory (ISO/FDA) compliance
• Expansion of contract manufacturing and custom synthesis services
• Increased adoption in diagnostics, biotechnological R&D, and gene therapy

2. Core Technical Data: Specification Table of 5 Bromouracil

3. 5-Bromouracil Manufacturing Process Flow (Visualized)

Key Manufacturing Aspects:

• Material Origin: Analytical-grade uracil and high-purity brominating agent
• Typical Process: Flow chemistry reactors for scale efficiency & safety
• Unit Operations: Catalytic bromination → cold crystallization → vacuum drying
• Certification: ISO 9001, FDA (where GMP required), CoA, DMF
• Typical Yield: ≥ 95% w/w, with impurity residues <0.5% (GC-MS validation)
• Manufacturing Lead Time: 1.5-2 weeks/batch

4. Product Material & Process Advantages

• Reactive Material: An aromatic, heterocyclic pyrimidine, highly electron-deficient, enabling tailored nucleophilic analog synthesis.
• Purification Process: Multi-stage (HPLC, crystallization) surpassing USP/ISO residue limits.
• Quality Test: Uses HPLC (High Performance Liquid Chromatography), GC-MS, NMR, and visual tests per ISO/USP.
• Mechanical Property: Exceptionally stable under standard storage, with storage life of >24 months (desiccated, 2–8℃).
• Industry Use: Widely used in pharmaceuticals, biotechnology, chemical R&D, academic research.
• Corrosion & Resistance: Chemically resistant, thermally stable, and compatible with high-throughput synthesis protocols.

Image: High-purity 5 bromouracil crystalline powder

5. Manufacturer Comparison Table

6. Customization & Service Solutions

• Custom batch: Provide tailored quantities (from 100g R&D to 2 tons commercial), particle size adjustment, impurity control documentation, ISO/USP/FDA compatibility.
• Custom packaging: Pharmaceutical-grade, UV-protected, antistatic drums or vials (10g → 1kg unit packs), with COA and BSE/TSE statements.
• Technology support: Analytical method development, process validation, stability protocol, and regulatory compliance support for DMF/CEP filing.
• Logistics: Global express, cold-chain optional, shipment tracking, and DDP service in over 40 countries.
• Post-sale technical support: 24/7 expert helpline for process troubleshooting, compatibility studies, and documentation audit.
• Lead time: Shorter cycle: stock—5 days, custom batch—7–18 days depending on customization scope.
• Warranty: 24 months from date of manufacture under standard storage, with COA and full traceability.

7. Applications of 5 Bromouracil in Real Industries

8. Technical Parameter Line Chart

9. Typical Application Scenarios: Why 5 Bromouracil Excels

• Antitumor and Antiviral Medications: As a thymine mimic, enables synthesis of 5-fluorouracil, tegafur, and other cytostatic drugs.
• Gene Mutation & Labeling: Used as a mutagenic base in gene-editing, DNA mismatch repair research, and viral diagnostics.
• Pharmaceutical R&D: Reactivity allows for quick customization in new pyrimidine-based candidate molecules.
• Laboratory Diagnostics: Component in enhanced PCR & qPCR kits for high-sensitivity detection of nucleic acids.
• Others: GRAS status in limited research applications, and academic chemistry for nucleic acid pathway elucidation.

10. Professional Terminology Q&A: 5 Bromouracil

1. Q1: What is the chemical structure of 5 bromouracil?
   A: 5-Bromouracil (C4H3BrN2O2) is a brominated analogue of uracil, consisting of a six-membered pyrimidine ring with a bromine atom at the 5-position. This unique substitution makes it an effective thymine mimic in DNA.
2. Q2: What purity and specification standards apply to 5 bromouracil?
   A: Top-grade commercial batches (≥99.0%) are validated via HPLC and comply with ISO9001:2015, USP42, and ICH Q1A stability testing. Custom grades may be supplied for research or GMP APIs.
3. Q3: What are typical packaging and storage requirements?
   A: Pharmaceutical-grade, double PE bag, dark container111, BSE-free, and desiccated at 2–8℃. Packaging sizes range from 10g up to industrial pails (25kg), maintaining stability for ≥24 months.
4. Q4: Which analytical methods certify batch integrity?
   A: HPLC for purity, GC-MS for trace organics, NMR for structural identity, and ISO visual/melting point. All analytical certificates (COA, DMF) are batch-specific.
5. Q5: What industry certifications are associated with top 5 bromouracil vendors?
   A: Vendors commonly possess ISO9001:2015, some have FDA DMF type II (for API uses), as well as documentation supporting cGMP compliance and traceability records.
6. Q6: Is 5 bromouracil compatible with high-throughput or automated synthesis technologies?
   A: Yes. Its high solubility in alcohols and automated weighing/dispensing support make it suitable for flow-chemistry, continuous processing, and combinatorial library synthesis.
7. Q7: What is the typical delivery cycle and support model?
   A: Fast delivery (stock: 5–7 days; custom: 10–18 days) with 24-month product warranty, 24/7 online expertise, real-time technical documentation, and regulatory compliance support (DMF, CEP).

11. Delivery, Service, and Quality Assurance

• Lead time: Stocked SKUs ship in 3–5 days; new synthesis or custom packaging takes 7–18 days.
• Quality warranty: 24 months from date of manufacture (stored as prescribed) with full traceability.
• Support: Dedicated PhD-level chemist support, regulatory documentation, and documentation audit.
• Certifications: ISO9001:2015, CoA, and where needed, FDA DMF. On-demand supporting documents (COO, BSE, TSE, MSDS, etc.).
• Post-sale service: Real-time problem response channel, product recall protocol, and custom synthesis consultancy.

12. References & Further Reading

• ScienceDirect – 5-Bromouracil: Biochemistry and Applications
• The Journal of Biological Chemistry – Mechanism of 5-Bromouracil in Genetics
• PharmaCompass – Global Suppliers & Regulatory Data of 5-Bromouracil
• ChemForum – Practical Aspects of 5-Bromouracil Handling