Introducing Edoxaban Impurity 103 - Advanced Reference Standard for Analytical Precision

Pune, India - July 2025 - Aquigen Biosciences is proud to announce the addition of Edoxaban Impurity 103 to its premium portfolio of analytical standards for pharmaceutical R&D. With rising demands in the development and regulatory scrutiny of anticoagulant APIs, having access to highly characterized impurity standards is critical for pharmaceutical innovators worldwide.

What is Edoxaban Impurity 103?
For full specifications, see Aquigen's product page for Edoxaban Impurity 103:
https://aquigenbio.com/product/edoxaban-impurity-103/

Edoxaban Impurity 103, also known by its CAS number 480450‐85‐9, is a structurally defined process-related impurity of Edoxaban-an FDA‐approved factor Xa inhibitor used in stroke prevention and thrombosis treatments.

This impurity exists as a stable ethyl ester intermediate, with a chemical formula C21H31N5O5S and a molecular weight of 465.6 g/mol.
Characterized meticulously-including NMR, LC-MS, and purity analysis-it is supplied in its free base form and also as a TFA salt, ensuring researchers can select the most chemically appropriate form for their methods.

Why Edoxaban Impurity 103 Matters
Regulatory compliance: A necessary reference for AMV (analytical method validation), QC checkpoints, and ANDA filings.

Process optimization: Enables formulation scientists to track impurity formation and ensure robust synthesis of Edoxaban APIs.

Traceability excellence: Can be matched against USP/EP pharmacopeial standards for increased traceability and regulatory assurance.

Versatile application: Foundational for impurity profiling, stability studies, forced degradation testing, and establishing impurity specifications.

Technical Specifications
Chemical Name:
Ethyl 2‐(((1S,2R,4S)‐4‐(dimethylcarbamoyl)-...‐oxoacetate), trifluoroacetate salt (TFA).
Formats:
Free base or TFA salt.
Shipping & Storage:
Ambient temperature shipping; store at controlled room temperature.
Origin:
Manufactured in India with full batch certificates of analysis.

Technical sheets and SDS documents are available upon request.

Explore Related Impurities
Edoxaban Impurity 100 - Chloro‐pyridinyl Oxo-Acetic Acid
Overview: Small chemical weight impurity (C7H5ClN2O3, 200.6 g/mol, CAS 552850‐73‐4) found during API intermediate degradation.
Applications: Ideal for analyzing early-stage process variation and degradation products.

Details: Aquigen's product page: https://aquigenbio.com/product/edoxaban-impurity-100/

Edoxaban Impurity 101 - Intermediate Cyclohexyl-Pyridinyl Derivative
Overview: C12H20N4O4 impurity (molecular weight 284.3 g/mol) associated with mid-stage synthesis tlcstandards.comsynzeal.com.

Applications: Supports method validation targeting mid-pathway process impurities.

Details: Aquigen's product page: https://aquigenbio.com/product/edoxaban-impurity-101/

Including these related impurities in your analytical toolkit provides a powerful, integrated platform to secure purity, traceability, and regulatory compliance throughout Edoxaban development.
Broad Impurity Standards Portfolio

Discover the full range of Edoxaban impurity reference standards at Aquigen's dedicated category page:
https://aquigenbio.com/products/impurity-standards/edoxaban/

This category includes a carefully curated spectrum of impurities-from early synthetic fragments to late-stage metabolites and nitrosamine analogs-supporting any stage of Edoxaban research and quality assessment.

Aquigen's Edge in Analytical Standards
Comprehensive data support: Certificates of Analysis (COA), NMR, LC-MS, and UV data available for every impurity.

Regulatory-grade production: Manufactured under GLP-aligned conditions in certified labs.

Flexible packaging: Multiple pack sizes to scale with your project needs.

Global logistics: Exported worldwide with ambient-temperature shipping-no cold chain needed.

Who Benefits?
Pharma R&D teams engaged in API synthesis and impurity profiling.
Contract Research Organizations (CROs) validating analytical methods.
Generics manufacturers preparing ANDA submissions.
Regulatory consultants overseeing dossier development and impurity thresholds.

By integrating Edoxaban Impurity 103 and its companion standards in your workflows, you can ensure precise detection of known and unknown impurities, supporting method robustness and regulatory readiness.

Contact:
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Phone: +91 7030123794
Email: bd@aquigenbio.com
Visit: www.aquigenbio.com

About Aquigen Biosciences

Aquigen Biosciences is a leading provider of high-quality reference standards, impurities, and custom synthesis solutions for pharmaceutical research and development. Based in India, Aquigen serves global clients with a strong focus on regulatory compliance, scientific accuracy, and customer-centric support. Our portfolio spans a wide range of API impurities, metabolites, and stable isotope-labeled compounds, all manufactured under stringent quality controls and delivered with comprehensive analytical documentation. At Aquigen, we are committed to advancing pharmaceutical innovation by ensuring researchers and formulators have access to precise, reliable, and traceable chemical standards.

This release was published on openPR.