Description

Apixaban Impurity 71 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Apixaban, a widely prescribed anticoagulant medication. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and impurity profiling. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Apixaban active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Used in the development and optimization of chromatographic methods (HPLC, UPLC) for impurity separation and detection.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control the level of specified impurities, ensuring compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Essential for preparing impurity identification and qualification reports required for drug master files (DMFs) and regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Used as a marker to track impurity formation in Apixaban formulations under various stress and storage conditions.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing robust purification processes.

Basic Information

Product Name	Apixaban Impurity 71
CAS No.	1998079-11-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 71; Apixaban Impurity G; 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 71; 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide; BMS-562247-01 Impurity
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 71 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 and released with a comprehensive Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, NMR, and MS. We adhere to relevant industry guidelines, including ICH Q3A/B for impurities, to support our clients' regulatory needs.

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 Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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