Description

Apixaban Impurity Bms-591329 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 of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and contract testing laboratories.

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.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Apixaban batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and optimizing the Apixaban synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Apixaban Impurity Bms-591329
CAS No.	2029205-64-7
Molecular Formula	C25H25N5O4
Molecular Weight	459.50 g/mol
Synonyms	BMS-591329; 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 B; Apixaban Impurity 2; Apixaban EP Impurity B; Apixaban USP Impurity B; 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

Our Apixaban Impurity Bms-591329 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS to confirm identity and purity, ensuring compliance with pharmacopeial standards for reference materials. A detailed Certificate of Analysis (COA) is provided with every shipment, containing batch-specific data on purity, impurities, and analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.