2-[2-(2-Fluorophenyl)-2-oxoethyl]propanedinitrile

Vonoprazan Impurity (CAS 312307-38-3) | High-Purity Reference Standard for Pharmaceutical Analysis‌
‌Google Search Keywords‌: Vonoprazan Impurity, CAS 312307-38-3, Vonoprazan Related Compound, API Impurity Standard, Pharmaceutical Analytical Reference

🔬 ‌Product Overview‌
Vonoprazan Impurity (CAS 312307-38-3) is a characterized reference material used for quality control and analytical testing during the production of Vonoprazan, a potassium-competitive acid blocker (P-CAB) for treating acid-related gastrointestinal disorders. This impurity is essential for ensuring compliance with regulatory standards and maintaining API purity.
‌Primary Function‌: Critical for impurity profiling, method validation, and stability studies.
‌Applications‌: Pharmaceutical R&D, quality assurance, regulatory submissions.

✅ ‌Key Advantages‌
⭐ ‌High Purity & Precision‌

• Purity ≥98% (HPLC/LC-MS certified), ensuring reliable analytical results.

📜 ‌Regulatory Compliance‌

• Fully characterized (NMR, IR, Mass Spec) and aligned with ‌ICH Q3A/B guidelines‌.

🌡️ ‌Stability Assurance‌

• Stable under recommended storage conditions (2-8°C), with long-term degradation studies available.

⚡ ‌Fast Turnaround‌

• Ready-to-ship batches with same-day dispatch for urgent projects.

📋 ‌Applications‌

1. ‌API Quality Control‌: Identification and quantification of impurities in Vonoprazan batches.

2. ‌Method Development‌: Supports HPLC/LC-MS method validation for regulatory filings.

3. ‌Stability Studies‌: Monitors degradation pathways during drug storage and formulation.

4. ‌GMP Compliance‌: Essential for audits and regulatory documentation (USFDA, EMA).

🏅 ‌Quality Certifications‌

• Rigorously tested via ‌HPLC, LC-MS, NMR, and FTIR‌ (compliant with USP/EP/ICH standards).

• Batch-specific Certificate of Analysis (CoA) with detailed spectral data and chromatograms.

🌐 ‌Market Trends‌
The global pharmaceutical impurity reference standards market is projected to grow at ‌7.1% CAGR (2024-2030)‌, driven by stringent regulatory requirements and rising demand for acid-suppression therapies like Vonoprazan. Demand for well-characterized impurities is surging, particularly in Asia-Pacific markets expanding generic drug production.

🔍 ‌Why Choose Us?‌

• ‌GMP/ISO Compliant‌: Produced in certified facilities with full traceability.

• ‌Custom Synthesis‌: Tailored impurity profiling and isolation services.

• ‌Global Support‌: Fast shipping with cold-chain logistics for sensitive standards.