Description

Entacapone is a potent and selective catechol-O-methyltransferase (COMT) inhibitor used as an active pharmaceutical ingredient (API). It is a critical component in combination therapies for the management of Parkinson's disease, enhancing the efficacy and duration of action of levodopa. This high-purity compound is essential for pharmaceutical manufacturers developing advanced neurological treatments, ensuring reliable and consistent drug performance for global healthcare providers.

Application

• Pharmaceutical API: Primary use as the active ingredient in anti-Parkinson's medications, specifically in combination with levodopa and carbidopa.
• Fixed-Dose Combination Tablets: Formulation into tablets such as Stalevo® (levodopa/carbidopa/entacapone) to improve patient compliance and therapeutic outcomes.
• Neurological Research: Used in preclinical and clinical research to study COMT enzyme inhibition and its effects on dopamine metabolism.
• Generic Drug Manufacturing: Sourcing for the production of generic versions of branded entacapone-containing pharmaceuticals.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical testing in laboratories.

Basic Information

Product Name	Entacapone
CAS No.	130929-57-6
Molecular Formula	C14H15N3O5
Molecular Weight	305.29 g/mol
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide; OR-611; Comtan; Entacapon; Entacapone; E-491; Contan; Contan
EINECS	Contact for details

Quality Control

Our Entacapone is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including HPLC for assay and impurity profiling, residual solvent analysis, and microbiological examination. A detailed Certificate of Analysis (COA) is provided with each shipment to guarantee identity, purity, strength, and composition.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to greenish-yellow crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with EP/USP <61>

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