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5 bromouracil
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 Parameter Specification Test Standard Product Name 5-Bromouracil In-house/ISO 9001:2015 Chemical Formula C4H3BrN2O2 GC-MS CAS Number 51-20-7 IUPAC Molecular Weight 189.99 g/mol NMR Purity ≥ 99.0% (HPLC) HPLC/ISO17025 Melting Point 285–289℃ ISO 3146 Appearance White crystal/powder Visual/ISO 9001 Solubility Slightly soluble in water, soluble in alcohol USP42 Storage Temp. 2-8℃ (Desiccated) ICH Q1A Typical Residue <0.5% USP42 3. 5-Bromouracil Manufacturing Process Flow (Visualized) Raw Material Reception Selection & QC: Uracil, Br2, solvents ISO 9001/CoA checked → Bromination Controlled reaction 20–25℃ Flow-chem reactor Catalyst, inert atmosphere → Crystallization Purified under -5℃ Recrystallize & filter ISO 3146 verified → Centrifugation & Drying Vacuum dry 55℃ Residue <0.5% → QC / Certification HPLC, GC-MS, NMR ISO 9001, DMF, COA 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 Manufacturer Capacity (kg/month) Purity (%) ISO/FDA Cert. Custom Synthesis Delivery Cycle Major Clients Moneide Chem 6,000 ≥99.0 ISO9001, (DMF) Yes, up to 2 ton 5-10 days Pfizer, Roche, Universities Company A 4,500 98.5–98.7 ISO9001 Limited 14–21 days Generics Factories Company B (EU) 2,800 ≥99.2 ISO9001, FDA Yes 18–30 days Local Biotech 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 Case 1: Oncological Drug Synthesis (Pharma Sector) Client: Multinational oncology pharmaceutical factory Application: Used 5 bromouracil as a thymine analogue precursor in synthesizing 5-fluorouracil derivatives. Outcome: Batch rejection rate fell from 2.7% to 0.5% after switching to Moneide Chem's high-purity product. Feedback: “Process reproducibility improved, with lower batch variance and full regulatory traceability.” Case 2: Academic Research & Nucleic Acid Studies Institution: Biotechnology Institute, East Asia Use: As a DNA base-pair mutation marker in gene-editing experiments Outcome: Achieved >99.7% base-pairing accuracy & cited in four peer-reviewed journal publications. Feedback: “Ultra-low impurity levels were critical for our in vivo genetic fidelity studies.” Case 3: Diagnostic Kit Manufacturing Client: Healthcare diagnostics company (EU) Application: Component in PCR enhancer formulations for improved signal/noise. Result: Enhanced test throughput by 8% monthly and received CE-mark clearance with Moneide Chem's batch. 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 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. 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. 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 . 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. 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. 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. 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. Contact for 5 Bromouracil Custom Solution 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
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