Description

Acitretin Impurity III (13-Ethyl Acitretin) CAS NO 1313741-10-4 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity of Acitretin, a retinoid medication, and is essential for ensuring drug safety and regulatory compliance. It is primarily needed by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and biotechnology industries for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of 13-Ethyl Acitretin in Acitretin drug substances and finished products.
• Analytical Method Development and Validation: Critical for developing, calibrating, and validating chromatographic methods, particularly HPLC and LC-MS, to meet ICH Q3A/B guidelines.
• Quality Control and Assurance: Employed in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopoeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (light, heat, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Retinoid Chemistry: Serves as a valuable intermediate or analog in ongoing research into the structure-activity relationships of synthetic retinoids.

Basic Information

Product Name	Acitretin Impurity III (13-Ethyl Acitretin)
CAS No.	1313741-10-4
Molecular Formula	C23H28O3
Molecular Weight	352.47 g/mol
Synonyms	13-Ethyl Acitretin; 13-Ethylretinoic Acid; (2E,4E,6E,8E)-9-(4-Ethoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic Acid; Acitretin EP Impurity C; Acitretin Related Compound C; Etretin Impurity; Ro 13-6298 Impurity
EINECS	Contact for details

Quality Control

Every batch of Acitretin Impurity III is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity, structural confirmation, and quantitative assay. A detailed Certificate of Analysis (COA) is supplied with each shipment, containing batch-specific results from HPLC, NMR, and MS. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). The compound is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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