3-Morpholino-1-(4-(2-oxopiperidin-1-yl)phenyl)-5,6-dihydropyridin-2(1H)-one

‌✨ Apixaban Impurity (CAS 545445-44-1) ✨‌
‌🔍 Google Search Keywords:‌ Apixaban Impurity, CAS 545445-44-1, Apixaban Related Compound, Pharmaceutical Reference Standard, Analytical Impurity

‌📌 Product Overview‌

Apixaban Impurity (CAS 545445-44-1) is a well-characterized reference standard used in the quality control and analytical testing of Apixaban, a widely prescribed anticoagulant. This impurity plays a critical role in ensuring drug safety, compliance, and regulatory approval by identifying and quantifying trace-level contaminants during API manufacturing.
‌Main Function‌: Analytical reference material for impurity profiling.
‌Applications‌: Pharmaceutical QC/QA, regulatory compliance, R&D studies.

‌✅ Key Benefits‌

‌🔬 Application Areas‌

1. ‌Pharmaceutical QC‌: Critical for impurity identification in Apixaban API and formulations.

2. ‌Method Validation‌: Supports analytical method development and validation.

3. ‌Regulatory Submissions‌: Required for FDA, EMA, and ICH compliance documentation.

4. ‌Academic Research‌: Used in pharmacokinetic and stability studies.

‌📜 Quality Certifications‌

• ‌Testing Methods‌: HPLC, LC-MS, NMR, FTIR.

• ‌Compliance‌: USP, EP, ICH standards.

• ‌Packaging‌: Amber vials, stored at 2-8°C to ensure integrity.

‌📈 Market Trends‌

The demand for Apixaban impurities is rising with ‌6.5% CAGR (2024-2030)‌, driven by stringent regulatory requirements for generic drug approvals and increased focus on drug safety. Global pharmaceutical manufacturers prioritize high-quality reference standards to accelerate commercialization.