Description

Apixaban Impurity 23 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Apixaban. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Apixaban Impurity 23 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Apixaban batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation and level of this specific impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Supports synthetic route optimization and degradation pathway studies in pharmaceutical R&D laboratories.

Basic Information

Product Name	Apixaban Impurity 23
CAS No.	1801881-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 23; Apixaban Impurity C; 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; Eliquis Impurity 23; BMS-562247-01 Impurity
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 23 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

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

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