Description

Apremilast Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Apremilast. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Apremilast.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Apremilast Impurity 15 in API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for Apremilast.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., with FDA, EMA).
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes.

Basic Information

Product Name	Apremilast Impurity 15
CAS No.	2096492-41-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 15; Apremilast Impurity; Apremilast EP Impurity; Apremilast USP Impurity; Otezla Impurity 15; CC-10004 Impurity; Phosphodiesterase 4 (PDE4) Inhibitor Impurity; (S)-2-((1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-acetamidoisoindoline-1,3-dione Impurity (IUPAC-based)
EINECS	Contact for details

Quality Control

Our Apremilast Impurity 15 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.