High-Purity Apremilast API Powder | CAS 608141-41-9

Apremilast (CAS No. 608141-41-9) is a potent, small-molecule selective inhibitor of phosphodiesterase 4 (PDE4). As a breakthrough oral therapeutic agent for chronic inflammatory conditions, it specifically modulates the intracellular network of pro-inflammatory and anti-inflammatory mediators. Manufactured under stringent cGMP-compliant protocols, Xi'an Tihealth supplies pharmaceutical-grade Apremilast crystalline powder with an HPLC-validated purity of ≥99.0%. Our API features a strictly controlled Form B crystalline habit and optimized particle size distribution, making it the ideal starting material for manufacturing generic oral solid dosages targeting plaque psoriasis, psoriatic arthritis, and Behçet's Disease.

To ensure bioequivalence and formulation stability, our Apremilast API undergoes rigorous analytical verification against industrial and regulatory monographs:

Apremilast exerts its immunomodulatory effect through the targeted regulation of intracellular signaling pathways:

• PDE4 Inhibition: It selectively inhibits Phosphodiesterase 4 (PDE4), the dominant cAMP-metabolizing enzyme in inflammatory cells. This leads to a significant elevation in intracellular cyclic adenosine monophosphate (cAMP) levels.
• Cytokine Balance: The increased cAMP downstream suppresses the expression of pro-inflammatory cytokines (such as TNF-α, IL-17, and IL-23) while concurrently upregulating anti-inflammatory mediators like IL-10.
• Systemic Inflammation Control: By acting non-biologically on the innate and adaptive immune response, it provides clinical relief from the epithelial hyperplasia and inflammatory infiltration characteristic of psoriasis.

• Oral Solid Dosage Forms: The primary API utilized in formulating film-coated tablets (typically 10mg, 20mg, and 30mg) for long-term management of autoimmune skin conditions.
• Indication-Targeted R&D: Essential starting material for researchers developing novel combination therapies or specialized drug delivery systems for chronic inflammatory diseases.

Our standard pharmaceutical-grade Apremilast is 100% Polymorphic Form B. This specific crystalline habit is widely recognized for its optimal thermodynamic stability and predictable dissolution rate, making it the industry standard for tablet formulation.

How do you ensure the chiral purity of this S-enantiomer?

We utilize a specialized chiral synthetic route combined with High-Performance Liquid Chromatography (HPLC) using chiral stationary phases. Every batch is validated to ensure the S-enantiomer content exceeds 99.5%, ensuring maximum therapeutic potency.

Are your technical documents ready for regulatory drug filings?

Yes. Xi'an Tihealth provides a comprehensive technical package including the Certificate of Analysis (COA), Method of Analysis (MOA), MSDS, and stability data. We support our pharmaceutical partners through their qualification audits and regulatory drug submissions.