Description

Apremilast Impurity 10 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 analysis. 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 this specific impurity in Apremilast API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with strict pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and increase of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Apremilast Impurity 10
CAS No.	1809170-71-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide; Apremilast Related Compound 10; Otezla Impurity 10; CC-10004 Impurity 10; (S)-N-(2-(1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
EINECS	Contact for details

Quality Control

Our Apremilast Impurity 10 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and stability, aligning with current industry standards for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and mass spectrometry analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is moisture-sensitive; keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.