Description

Apixaban Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Apixaban, a widely prescribed anticoagulant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification in Apixaban API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) for accurate quantification of related substances.
• Quality Control and Release Testing to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies to monitor the formation of degradation products under various stress conditions.
• Regulatory Submissions and Compliance, providing essential data for drug master files (DMFs) and regulatory audits.
• Research and Development of Apixaban synthesis pathways and impurity formation mechanisms.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Apixaban Impurity 7
CAS No.	1074549-87-3
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 Related Compound 7; Apixaban EP Impurity G; Apixaban USP Impurity 7; 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 Impurity 7 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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