Description

Apixaban Impurity 31 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 during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on cardiovascular therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control of Apixaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate, identify, and quantify this specific impurity.
• Stability Studies: Used to monitor the formation and levels of Apixaban Impurity 31 in stability samples under various ICH conditions to establish drug shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity profiling and characterization data.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, helping to optimize manufacturing processes for impurity minimization.
• Pharmacopoeial Testing: Employed in testing to meet the stringent impurity limits set by pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).

Basic Information

Product Name	Apixaban Impurity 31
CAS No.	2458079-10-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 31; Apixaban Impurity O; 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-7V8R8N6W1T; 7-Oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1-(4-methoxyphenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 31 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation.

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)	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.