Description

Apremilast Impurity 28 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Apremilast API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm that Apremilast batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Acts as a marker to track the formation of this specific impurity under various stress conditions (heat, light, humidity).
• Research & Development: Utilized in R&D to understand the degradation pathways and synthesis process of Apremilast.

Basic Information

Product Name	Apremilast Impurity 28
CAS No.	1802246-60-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 28; Apremilast Impurity 28 (CAS 1802246-60-1); Apremilast EP Impurity 28; Apremilast USP Impurity 28; Otezla Impurity 28; Phosphodiesterase 4 (PDE4) Inhibitor Impurity; (S)-N-(2-(1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide (Related Structure)
EINECS	Contact for details

Quality Control

Our Apremilast Impurity 28 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, assay, and chromatographic data. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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 Impurities (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.