Description

Apremilast Impurity 4 is a designated impurity reference 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 benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Apremilast.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Apremilast Impurity 4 in API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UHPLC).
• Stability Studies: Used to monitor the formation and level of this specific impurity during forced degradation and long-term stability testing of Apremilast.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Quality Control Testing: Employed in routine batch release testing of Apremilast API to ensure compliance with established impurity specifications.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification stages of Apremilast manufacturing.

Basic Information

Product Name	Apremilast Impurity 4
CAS No.	1831833-38-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 4; Apremilast Impurity D; Apremilast EP Impurity D; Apremilast USP Impurity 4; Otezla Impurity 4; CC-10004 Impurity 4; Phosphodiesterase 4 (PDE4) Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Apremilast Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, identity confirmation (e.g., by IR or MS), and residual solvent analysis. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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% w/w

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