Description

Idebenone Impurity 8 CAS NO 104967-07-9 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the pharmaceutical compound Idebenone. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and research. It is primarily used by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure the purity, safety, and efficacy of Idebenone-based drug substances and products.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Idebenone active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for Idebenone analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions to establish product shelf-life and storage guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Idebenone API and finished drug products comply with stringent pharmacopeial (e.g., USP, EP) and ICH regulatory specifications for impurities.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research on Idebenone Metabolism and Degradation Pathways: Aids in research studies investigating the chemical behavior, stability, and metabolic pathways of Idebenone.

Basic Information

Product Name	Idebenone Impurity 8
CAS No.	104967-07-9
Molecular Formula	C19H30O5
Molecular Weight	338.44 g/mol
Synonyms	2-(10-Hydroxydecyl)-5,6-dimethoxy-3-methyl-2,5-cyclohexadiene-1,4-dione; Idebenone Related Compound; Idebenone EP Impurity; Idebenone USP Impurity; 1,4-Benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-; Idebenone Degradation Product; Idebenone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Idebenone Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain optimal stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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