Description

Apixaban Impurity 33 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Apixaban. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Apixaban API and its finished dosage forms.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, or LC-MS methods for the accurate identification and quantification of impurities in Apixaban.
• Regulatory Compliance & Filings: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products during forced degradation and long-term stability studies of Apixaban.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways, aiming to minimize the formation of this specific impurity.
• Pharmacopoeial Testing: Applied as a system suitability test component in assays and impurity tests as per pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Apixaban Impurity 33
CAS No.	1686149-78-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 33; Apixaban EP Impurity J; Apixaban USP Impurity; 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; Eliquis Impurity 33; BMS-562247 Impurity
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment to support your regulatory and quality assurance needs.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to prevent moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.