?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.