Description

Apixaban Related Compound 4 is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound serves as a critical impurity marker and analytical standard in the quality control of the active pharmaceutical ingredient (API) Apixaban, an important anticoagulant medication. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this material to ensure drug safety, efficacy, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Apixaban API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Apixaban under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the FDA and EMA.
• Pharmaceutical Research: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Apixaban.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product purity and consistency.

Basic Information

Product Name	Apixaban Related Compound 4
CAS No.	99585-01-0
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 4; Apixaban Related Substance 4; Apixaban EP Impurity D; Apixaban USP Related Compound D; 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Apixaban Related Compound 4 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 compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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