Description

Acitretin Impurity CAS NO 74479-46-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Acitretin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Acitretin drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of Acitretin batches to verify compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Acitretin formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Utilized in synthetic chemistry R&D to study the formation pathways and to develop purification processes for Acitretin.

Basic Information

Product Name	Acitretin Impurity
CAS No.	74479-46-2
Molecular Formula	C21H26O3
Molecular Weight	326.43 g/mol
Synonyms	Acitretin Related Compound; (2E,4E,6E,8E)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic Acid; Etretin Impurity; Neotigason Impurity; Soriatane Impurity; Retinoid Impurity; Arotinoid Impurity
EINECS	Contact for details

Quality Control

Our Acitretin Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with ICH guidelines. Our commitment to quality and traceability ensures reliability for your critical analytical and regulatory needs.

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 storing under an inert atmosphere.

Specification

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

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