Description

Apixaban Related Compound 3 is a high-purity chemical reference standard, essential for ensuring the quality and safety of pharmaceutical products. This compound is critical for the analytical development and quality control processes in the manufacturing of the anticoagulant drug Apixaban. It is primarily used by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Apixaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product consistency meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Apixaban formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this related compound during API synthesis.

Basic Information

Item	Detail
Product Name	Apixaban Related Compound 3
CAS No.	813452-05-0
Molecular Formula	C25H25N5O4
Molecular Weight	459.50 g/mol
Synonyms	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; Apixaban Impurity 3; Apixaban Related Substance 3; Apixaban EP Impurity C; UNII-9K5P8F42BX; Apixaban Process Impurity; 1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-
EINECS	Contact for details

Quality Control

Every batch of Apixaban Related Compound 3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and MS, to ensure compliance with stringent pharmacopeial and in-house specifications. A comprehensive Certificate of Analysis (COA) detailing all test results, including assay and impurity profiles, is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
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.