?? 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.