Description

Idebenone Impurity 5 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Idebenone active pharmaceutical ingredient (API) manufacturing. It is primarily used by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent global regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods in QC/QA laboratories.
• Method Development & Validation: Used in the development and validation of HPLC, UPLC, and GC methods for impurity profiling of Idebenone.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Idebenone formulations under various stress conditions.
• Process Chemistry Optimization: Helps chemists identify the source of impurities during API synthesis, enabling process refinement and improved yield.
• Academic & Contract Research: Used in universities and CROs for pharmacological studies and analytical research related to Idebenone and its metabolites.

Basic Information

Product Name	Idebenone Impurity 5
CAS No.	88543-33-3
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 Degradant; Idebenone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Idebenone Impurity 5 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for audit and regulatory review.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.