✨ 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
| 🧪 High Purity | 📊 Precision Analysis | 🛡️ Regulatory Alignment |
|---|
| Purity ≥98% (HPLC) | Validated for HPLC/LC-MS | Meets ICH Q3B(R2) guidelines |
| 🌡️ Stability | 📦 Batch-to-Batch Consistency |
|---|
| Stable under recommended storage | Certified COA for every batch |
🔬 Application Areas
Pharmaceutical QC: Critical for impurity identification in Apixaban API and formulations.
Method Validation: Supports analytical method development and validation.
Regulatory Submissions: Required for FDA, EMA, and ICH compliance documentation.
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.
China
