Huzhou Ureda Pharmaceutical Co., Ltd. supplies two high-purity benzimidazole-based intermediates used as strategic building blocks in the synthesis of azilsartan and candesartan ester APIs. Each intermediate is manufactured under pharma-grade process control, released with a full Certificate of Analysis (CoA), and supported by a technical dossier to accelerate R&D, minimize downstream risk and simplify regulatory filings.
Product Core Information
Intermediate A (representative name):
Methyl 1-[(2′-cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H-benzimidazole-7-carboxylate
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CAS: 139481-44-0
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Molecular formula: C₂₅H₂₁N₃O₃
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Molecular weight: 411.45 g·mol⁻¹
Intermediate B (representative name):
Ethyl 1-[(2′-cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H-benzimidazole-7-carboxylate
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CAS: 139481-41-7
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Molecular formula: C₂₆H₂₃N₃O₃
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Molecular weight: 425.48 g·mol⁻¹
Full structure drawings (2D), InChI/SMILES, NMR, and MS data are included in the technical pack available upon request.
Technical Rationale — Why these intermediates matter
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Core structural motifs: The substituted biphenyl and benzimidazole motifs—combined with proper esterification—form the essential backbone for many sartans. Providing these fragments with controlled purity reduces chemical risk in later transformations toward azilsartan and candesartan esters.
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Downstream impact on yield & purification: Impurity carry-over from early intermediates commonly complicates API purification and reduces isolated yields. High-quality intermediates reduce chromatographic burden and improve batch yields.
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Process predictability: Tight control of physicochemical attributes (crystal form, particle size distribution, residual solvent profile) helps ensure predictable crystallization, filtration and drying behavior during scale-up.
Typical Physicochemical Profile & Handling
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Appearance: White to off-white crystalline powder.
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Solubility: Soluble in common organic solvents (e.g., DMSO, dichloromethane, ethyl acetate); solvent choice should be confirmed during route development.
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Stability: Stable under recommended storage conditions; stability summaries available.
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Analytical focus: Identity (1H/13C NMR), MS, assay (validated HPLC), related substances, residual solvents (GC), water (Karl Fischer) and heavy metals (ICP-MS).
Representative Specification (example — final CoA per batch)
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Assay (HPLC): ≥ 99.0% (typical)
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Individual related substances: ≤ 0.10–0.20% (typical; adjustable upon agreement)
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Total impurities: ≤ 0.50% (typical)
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Residual solvents: Compliant with ICH Q3C limits
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Water (KF): ≤ 1.0% (typical)
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Heavy metals: Within pharmacopeial limits or tighter by request
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Identity: Confirmed by NMR and MS
Final contractual specifications will be defined in the CoA provided with each shipment and can be customized to support regulated markets.
Manufacturing, Quality Control & Documentation
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Pharma-oriented production controls: Documented procedures, in-process controls and batch records that meet pharmaceutical supply expectations; change control implemented to protect product continuity.
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Robust purification & crystallization: Proprietary purification workflows and controlled crystallization reduce critical impurities and deliver reproducible crystal properties.
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Full QC release package: Every batch is released with a CoA including identity, assay, impurities, residual solvents, water and heavy metal results.
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Stability & regulatory support: Stability summaries and validated method descriptions included to facilitate regulatory filings and process transfer.
Packaging, Storage & Logistics
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Standard packaging: Inner sealed HDPE/PE bag + outer drum/carton; desiccant included; nitrogen blanketing available on request.
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Storage: Cool, dry, away from light — specific storage conditions and shelf life included in CoA.
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Logistics: Export-grade packing, experienced export handling and full export documentation for international shipping.
Customer Support & Services
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Technical pack available: 2D structures, InChI/SMILES, NMR spectra, HPLC method, MS data, residual solvent method, typical CoA and stability summary.
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Samples: Analytical and development samples provided on request (sample policy / NDA may apply).
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Custom specifications: Capable of tighter impurity limits, specific particle size control, and special packaging/labeling per contract.
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Scale flexibility: From grams for R&D to multi-kg commercial batches; lead time and MOQ depend on specification and scale.
Typical Use Cases
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Generic API manufacturers seeking reliable intermediates for candesartan/azilsartan process development and scale-up.
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Discovery and medicinal chemistry groups needing a high-quality benzimidazole fragment for structure-activity exploration.
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CMOs requiring stable intermediates to support multi-site production and regulatory submissions.
Practical Risk Control Recommendations (for customers)
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Request the full technical pack before process transfer and review impurity profiles against your downstream route.
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Run small confirmatory reactions to validate solvent selection and impurity behavior in your specific route.
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Specify contractual controls (residual solvent limits, heavy metals, particle size) at the RFQ stage to align production and QC release criteria.
Quality & Compliance Commitments
Huzhou Ureda commits to:
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Batch-to-batch consistency and traceable QC documentation;
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Providing validated analytical methods and supporting raw data under confidentiality;
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Proactive communication about lead times, change control and supply risks.
Request a Quote / Technical Inquiry (Call to Action)
To request samples, technical dossiers, or formal quotations, contact:
Huzhou Ureda Pharmaceutical Co., Ltd.
Contact / Sales & Technical: Owen Lee
WhatsApp: +86-18270717590
Email: (please provide your company email in the request)
Please include in your inquiry: desired CAS (139481-44-0 or 139481-41-7), required quantity, intended use (R&D or commercial), target market and any special testing/specification needs. We typically provide the technical pack within 24–48 hours upon formal request.
