Description

Difamilast is a potent and selective phosphodiesterase 4 (PDE4) inhibitor with significant anti-inflammatory properties. This compound matters for its targeted mechanism of action, offering a promising therapeutic approach for inflammatory skin conditions. It is primarily needed by pharmaceutical R&D teams and manufacturers developing novel topical treatments for atopic dermatitis and psoriasis.

Application

• Primary active pharmaceutical ingredient (API) in topical formulations for atopic dermatitis.
• Key component in clinical research for psoriasis and other chronic inflammatory skin diseases.
• Used in preclinical studies to investigate PDE4 inhibition pathways.
• Reference standard for analytical method development and quality control in pharmaceutical manufacturing.
• Building block for the synthesis of novel PDE4 inhibitor derivatives in medicinal chemistry.

Basic Information

Product Name	Difamilast
CAS No.	937782-05-3
Molecular Formula	C₂₀H₂₀N₄O₃
Molecular Weight	364.40 g/mol
Synonyms	OPA-15406; OPA15406; UNII-6J2Y7FKA8L; 6-[(3S,4R)-4-Methyl-1-(2-methylbenzoyl)-3-piperidinyl]-1,3-dimethyl-2,4(1H,3H)-pyrimidinedione; (3S,4R)-4-Methyl-1-(2-methylbenzoyl)-3-[1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-6-yl]piperidine; Difamilast (USAN); 6-[(3S,4R)-4-Methyl-1-(2-methylbenzoyl)piperidin-3-yl]-1,3-dimethylpyrimidine-2,4(1H,3H)-dione
EINECS	Contact for details

Quality Control

Our Difamilast is manufactured under strict quality management systems to ensure high purity and batch-to-batch consistency, suitable for pharmaceutical development. All batches are supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We adhere to cGMP standards where applicable, and specifications can be aligned with client-specific pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% 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.