Description

Apremilast CAS NO 1384440-16-7 is a small molecule phosphodiesterase 4 (PDE4) inhibitor, representing a significant advancement in targeted immunomodulatory therapy. Its primary value lies in its ability to regulate intracellular inflammatory mediators, offering a precise mechanism of action for managing chronic inflammatory conditions. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing treatments for psoriasis, psoriatic arthritis, and related autoimmune disorders.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral tablets for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
• Clinical Research: Critical reference standard and raw material for preclinical and clinical studies investigating PDE4 inhibition.
• Drug Development: Used in R&D for exploring new therapeutic applications in other inflammatory and autoimmune conditions, such as Behçet's disease and atopic dermatitis.
• Generic Drug Manufacturing: Serves as the key component for companies developing bioequivalent generic versions of branded apremilast medications.
• Analytical Testing: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical method development and validation.

Basic Information

Product Name	Apremilast
CAS No.	1384440-16-7
Molecular Formula	C22H24N2O7S
Molecular Weight	460.50 g/mol
Synonyms	CC-10004; Otezla (Brand Name); Apilimod; N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide; (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 is manufactured under strict quality management systems. We provide material that meets high-purity standards suitable for pharmaceutical development and manufacturing. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Our quality commitment ensures compliance with cGMP principles and relevant ICH guidelines, providing the supply reliability and documentation required for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

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