Description

Idebenone Impurity 9 is a specified impurity of the pharmaceutical compound Idebenone, a synthetic analog of coenzyme Q10. This impurity is critical for analytical reference and quality control in the development and manufacturing of high-purity Idebenone active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers engaged in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Idebenone Impurity 9 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Idebenone synthesis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine impurity profiling in pharmaceutical manufacturing to ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used by chemists to understand and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Idebenone Impurity 9
CAS No.	104966-92-9
Molecular Formula	C19H30O5
Molecular Weight	338.44 g/mol
Synonyms	2-(10-Hydroxydecyl)-5,6-dimethoxy-3-methyl-2,5-cyclohexadiene-1,4-dione; 6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benzoquinone; Idebenone Related Compound; Idebenone EP Impurity; Idebenone USP Impurity; Idebenone Process Impurity; Coenzyme Q10 Analog Impurity
EINECS	Contact for details

Quality Control

Every batch of Idebenone Impurity 9 is characterized and tested to ensure high chemical purity and authenticity, suitable for use as a reference standard. Our quality system ensures compliance with relevant guidelines for impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity (by HPLC), and other specified tests.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C or as indicated on the label or COA. Due to its hygroscopic nature, the container should be kept tightly sealed in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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