Description

Acitretin Impurity CAS NO 1621284-00-1 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, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Acitretin API batches.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for Acitretin analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency according to ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products in Acitretin formulations under various stability conditions.
• Research & Development: Supports synthetic chemistry research for understanding degradation pathways and optimizing synthesis processes of Acitretin.

Basic Information

Product Name	Acitretin Impurity
CAS No.	1621284-00-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acitretin Related Compound; Acitretin Impurity Standard; Acitretin Specified Impurity; (2E,4E,6E,8E)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid impurity; Etretin Impurity; Neotigason Impurity; Soriatane Impurity
EINECS	Contact for details

Quality Control

Our Acitretin Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and impurity profiles. Our quality standards align with ICH Q3A, Q3B, and relevant pharmacopeial guidelines to support your 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 must be kept in a desiccated environment to maintain stability. 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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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