Description

Idebenone Impurity 7 is a high-purity reference standard and synthetic intermediate critical for pharmaceutical research and development. This compound is essential for the analytical characterization, method validation, and quality control of Idebenone, a synthetic analog of coenzyme Q10. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development and production of Idebenone-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis to ensure the purity and safety of Idebenone active pharmaceutical ingredients (APIs).
• Method Development and Validation: Critical for developing and validating analytical methods in compliance with ICH Q2(R1) guidelines for the quantification of specific impurities.
• Quality Control & Assurance: Employed in routine batch testing within QC laboratories to monitor and control impurity profiles during Idebenone synthesis and formulation.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities in drug master files (DMFs).
• Process Chemistry Research: Serves as a key intermediate or marker in studying and optimizing the synthetic pathway of Idebenone.
• Stability Studies: Used to identify and track degradation products in forced degradation and long-term stability studies of Idebenone formulations.

Basic Information

Product Name	Idebenone Impurity 7
CAS No.	92038-37-4
Molecular Formula	C19H30O5
Molecular Weight	338.44 g/mol
Synonyms	2-(10-Hydroxydecyl)-5,6-dimethoxy-3-methyl-2,5-cyclohexadiene-1,4-dione; 10-Hydroxydecyl-2,3-dimethoxy-5-methyl-1,4-benzoquinone; Idebenone Related Compound; Idebenone EP Impurity; Idebenone USP Impurity; Idebenone Process Impurity; 1,4-Benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-
EINECS	Contact for details

Quality Control

Every batch of Idebenone Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH guidelines.

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 under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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