Description

Carbamazepine Impurity 6 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Carbamazepine. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during manufacturing and quality control processes. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of Carbamazepine and its related formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Carbamazepine Impurity 6 in drug substances and products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control and Assurance: Used in routine QC testing to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines, ensuring batch-to-batch consistency and regulatory compliance.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and toxicological profile of Carbamazepine and its related compounds.

Basic Information

Product Name	Carbamazepine Impurity 6
CAS No.	132648-81-8
Molecular Formula	C15H12N2O
Molecular Weight	236.27 g/mol
Synonyms	10,11-Dihydro-10-hydroxycarbamazepine; 10-Hydroxy-10,11-dihydrocarbamazepine; Carbamazepine 10,11-Epoxide Hydrolysis Impurity; Oxcarbazepine Related Compound A; 10-Hydroxy Oxcarbazepine; 10-Monohydroxy Carbamazepine; NSC 386840; Carbamazepine Metabolite
EINECS	Contact for details

Quality Control

Every batch of Carbamazepine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity (HPLC), related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions 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)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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