5-(2-Fluorophenyl)-1H-pyrrole-3-carbaldehyde

‌Apixaban Impurity 60A (CAS 881674-56-2) | Certified Reference Standard for Pharmaceutical QC‌
‌Google Search Keywords‌: Apixaban Impurity 60A, CAS 881674-56-2, Apixaban Related Compound, Anticoagulant Impurity Standard, Pharmaceutical QC Reference

🔬 ‌Product Overview‌
Apixaban Impurity 60A (CAS 881674-56-2) is a ‌pharmaceutically relevant impurity‌ associated with the synthesis or degradation of Apixaban, a widely prescribed anticoagulant (Factor Xa inhibitor). This impurity serves as a critical reference standard for quality control (QC) and regulatory compliance during Apixaban API and drug product manufacturing.
‌Primary Function‌: Ensures accurate identification, quantification, and control of impurities in Apixaban batches.
‌Applications‌: Pharmaceutical QC/QA, analytical method development, regulatory submissions.

✅ ‌Key Advantages‌
⭐ ‌High Purity & Precision‌

• Purity ≥98% (HPLC/LC-MS certified), with comprehensive spectral data (NMR, IR) for unambiguous characterization.

📊 ‌Regulatory Compliance‌

• Meets ‌ICH Q3B‌ guidelines for impurity profiling and USP/EP standards for reference materials.

🔬 ‌Batch Consistency‌

• Rigorous quality control ensures ≤0.5% variability between batches, ideal for method validation.

🌡️ ‌Stability Assurance‌

• Stable under recommended storage (-20°C, desiccated), ensuring long-term reliability.

📋 ‌Applications‌

• ‌API Batch Release‌: Critical for impurity identification in Apixaban API manufacturing.

• ‌Analytical Method Development‌: Calibration standard for HPLC/UPLC quantification.

• ‌Stability Studies‌: Monitors degradation pathways in drug product formulations.

• ‌Generic Drug Approval‌: Supports impurity control in bioequivalent Apixaban generics.

🏅 ‌Quality Certifications‌

1. Fully characterized via ‌HPLC, LC-MS, NMR, and FTIR‌ (aligned with ICH, USP, and EP protocols).

2. Detailed Certificate of Analysis (CoA) with structure elucidation and impurity traceability.

🌐 ‌Market Trends‌
The global anticoagulant market, valued at ‌$25.3 billion (2023)‌, is driven by the rising use of Apixaban (brand name Eliquis®) and its generics. With stringent regulatory scrutiny on impurity limits, demand for certified standards like Apixaban Impurity 60A is projected to grow at ‌7.5% CAGR (2024-2030)‌.

🔍 ‌Why Choose Us?‌

• ‌Custom Purity Grades‌: Available from 95% to 98%+ for research or commercial use.

• ‌Fast Turnaround‌: Ready-to-ship batches with ISO 17025-accredited testing.

• ‌Technical Support‌: Expert guidance on impurity profiling and regulatory documentation.