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.