Description

Apixaban Impurity 25 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Apixaban. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of anticoagulant medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Apixaban Impurity 25 in Apixaban API and finished dosage forms.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC) methods.
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Apixaban.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Process Chemistry Research: Aids in understanding and optimizing the Apixaban synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Apixaban Impurity 25
CAS No.	2133292-60-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 25; Apixaban EP Impurity 25; Apixaban USP Impurity 25; Apixaban Process Impurity 25; 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 (proposed); Eliquis Impurity 25; UNII-XXXX; BMS-XXXX Impurity
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 25 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including HPLC, NMR, and MS. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with current Good Manufacturing Practice (cGMP) and relevant pharmacopeial guidelines (USP, EP).

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.