Description

Apixaban Impurity 70 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Apixaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of specific impurities in Apixaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications, ensuring every batch of Apixaban meets stringent pharmacopeial standards (e.g., USP, EP).
• Stability Studies and Forced Degradation Studies: Acts as a marker to understand the degradation pathways of Apixaban and to establish shelf-life and storage conditions.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development: Utilized in synthetic chemistry R&D to study the formation and fate of process-related impurities during Apixaban manufacturing.

Basic Information

Product Name	Apixaban Impurity 70
CAS No.	1998079-14-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 70; Apixaban Impurity; 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide; UNII-Contact for details; Apixaban Process Impurity; Eliquis Impurity 70
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 70 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.