Description

Oxcarbazepine Impurity 8 is a specified impurity and a key chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Oxcarbazepine. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Oxcarbazepine API and its finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in Oxcarbazepine under various storage conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Pharmacopoeial Testing: Used in testing to comply with pharmacopoeial monographs (e.g., USP, EP, BP) that set limits for specified impurities.
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of this specific impurity during the manufacturing process.

Basic Information

Product Name	Oxcarbazepine Impurity 8
CAS No.	59690-99-2
Molecular Formula	C15H12N2O3
Molecular Weight	268.27 g/mol
Synonyms	10,11-Dihydro-10-hydroxy-5H-dibenz[b,f]azepine-5-carboxamide; 10-Hydroxy-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide; 10-Hydroxycarbamazepine; Oxcarbazepine Related Compound B; Oxcarbazepine EP Impurity B; Oxcarbazepine USP Related Compound B; 5H-Dibenz[b,f]azepine-5-carboxamide, 10,11-dihydro-10-hydroxy-
EINECS	Contact for details

Quality Control

Every batch of Oxcarbazepine Impurity 8 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment and is available upon request.

Storage

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

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 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.