Description

Apixaban Impurity 14/6-(4-Aminophenyl)-1-(4-Methoxyphenyl)-7-Oxo-4,5,6,7-Tetrahydro-1H-Pyrazolo[3,4-C]Pyridine-3-Carboxylic Acid is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis and validation of Apixaban, a leading anticoagulant medication, ensuring drug safety and regulatory compliance. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Apixaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure Apixaban meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradant under various stress conditions (forced degradation studies) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• 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 14/6-(4-Aminophenyl)-1-(4-Methoxyphenyl)-7-Oxo-4,5,6,7-Tetrahydro-1H-Pyrazolo[3,4-C]Pyridine-3-Carboxylic Acid
CAS No.	1704504-93-7
Molecular Formula	C21H19N3O4
Molecular Weight	377.40 g/mol
Synonyms	Apixaban Impurity 14; 6-(4-Aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid; 1-(4-Methoxyphenyl)-6-(4-aminophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid; Apixaban Related Compound 14; Eliquis Impurity 14; UNII-2V1Q2V8K3F; 2V1Q2V8K3F
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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