Description

Apremilast Impurity 14 CAS NO 2487573-08-8 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 (API) Apremilast. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity supports robust quality control processes in drug development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Apremilast API and finished drug products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity separation and detection.
• Stability Studies and Forced Degradation: Employed to monitor impurity profiles and understand degradation pathways of Apremilast under various stress conditions.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Apremilast batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria.
• Research and Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process development for Apremilast.

Basic Information

Item	Detail
Product Name	Apremilast Impurity 14
CAS No.	2487573-08-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 14; Apremilast Impurity; Otezla Impurity 14; (2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl)methyl acetate; 4-(Acetoxymethyl)-2-((1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione; UNII-7W0Q4B5U8I; 7W0Q4B5U8I
EINECS	Contact for details

Quality Control

Every batch of Apremilast Impurity 14 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures material suitability for its intended use in pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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