Description

Apremilast CAS NO 1384967-20-7 is a potent and selective small-molecule inhibitor of phosphodiesterase 4 (PDE4), which plays a critical role in regulating inflammatory mediators. This compound is of significant commercial importance as the active pharmaceutical ingredient (API) in approved treatments for psoriatic arthritis and plaque psoriasis. It is primarily required by pharmaceutical manufacturers and research organizations engaged in the development and production of innovative anti-inflammatory therapeutics.

Application

• Pharmaceutical Active Ingredient (API): Core component in the formulation of finished dosage forms for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
• Reference Standard: Serves as a high-purity calibrant in analytical laboratories for quality control (QC) and research & development (R&D) method validation.
• Clinical Research Material: Used in preclinical and clinical studies to investigate new therapeutic applications for PDE4 inhibition.
• Process Development: Employed as a key intermediate or benchmark in the development and optimization of synthetic routes for API manufacturing.
• Bioavailability Studies: Utilized in comparative studies for generic drug development and formulation improvement.

Basic Information

Product Name	Apremilast
CAS No.	1384967-20-7
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. It undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to stringent pharmaceutical-grade specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each batch to support your regulatory and quality assurance requirements.

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 under dry conditions to maintain stability and potency.

Specification

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