Description

Apremilast CAS NO 608141-41-9 is a potent and selective small-molecule inhibitor of phosphodiesterase 4 (PDE4), specifically developed for the treatment of inflammatory conditions. This compound matters significantly as a key active pharmaceutical ingredient (API) in modern therapeutics, offering a targeted mechanism of action. It is primarily needed by pharmaceutical manufacturers and research institutions focused on developing and producing advanced treatments for autoimmune and inflammatory diseases such as psoriasis and psoriatic arthritis.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of oral medications for inflammatory diseases.
• Psoriasis Treatment: Core component in drugs for moderate to severe plaque psoriasis.
• Psoriatic Arthritis Therapy: Used in medications to alleviate symptoms and modify the disease course in adults.
• Research & Development: Critical reference standard and biochemical tool for studying PDE4 inhibition and inflammatory pathways in preclinical research.
• Drug Product Manufacturing: Sourced by contract development and manufacturing organizations (CDMOs) for finished dosage form production.
• Regulatory Submissions: Serves as a characterized substance for drug master files (DMFs) and regulatory dossiers (e.g., for FDA, EMA).

Basic Information

Product Name	Apremilast
CAS No.	608141-41-9
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; Apremilastum; UNII-U3S7I3SJ1L
EINECS	Contact for details

Quality Control

Our Apremilast is manufactured under strict quality management systems, targeting high purity suitable for pharmaceutical applications. Each batch undergoes rigorous analytical testing, including HPLC for assay and impurity profiling, to ensure compliance with in-house specifications and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and residual solvents is provided with every shipment. We support regulatory requirements and can supply material referenced in relevant Drug Master Files (DMF).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
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.