Agomelatine CAS 138112-76-2

What Agomelatine Is

Agomelatine is the active ingredient in antidepressant tablets sold under names such as Valdoxan and in generic versions. Chemically it is N-[2-(7-methoxynaphthalen-1-yl)ethyl]acetamide, a methoxynaphthalene acetamide that crystallizes as a white to off-white powder, melts around 107 to 109 °C and dissolves readily in organic solvents but only sparingly in water. The molecule has no stereocenters, so enantiomeric control drops out of the quality work and attention falls on crystal form, residual solvents and impurity profiling. UATChem quotes and documents agomelatine as a pharmaceutical input for formulation developers, generic dose makers and CDMOs, with assay and impurities released on the COA.

Agomelatine in Pharmaceutical Manufacturing

• Generic tablets. Bulk API for film-coated oral tablets used in major depressive disorder in adults, following the originator product and available generic versions.
• Formulation and process development. Dissolution, bioavailability, crystal form and process work around a lipophilic, sparingly soluble API, including modified-release and alternative-delivery studies.
• Receptor profile. Agomelatine agonizes melatonin MT1 and MT2 receptors and antagonizes 5-HT2C, a profile linked in approved medicines to circadian and sleep effects, stated here as product identity rather than a treatment claim.

Typical Specifications

Agomelatine is released against the agreed pharmacopoeia or customer specification; EP, USP or JP monograph support can be arranged when an order names it. Assay, related substances, residual solvents and crystal form are reported on the COA, and the physical constants below identify the material.

Packaging, Documents and Ordering

• The API leaves in heat-sealed double polyethylene or foil bags, typically 1 kg or 5 kg net, packed into labeled fiber or cardboard drums; development samples and commercial multi-drum lots follow the same sealed, traceable format. Packs stay sealed, light protected, dry and cool at controlled room temperature, with refrigerated storage following the label where required, and the material moves as non-hazardous cargo under the supplied SDS.
• Every batch is released against the agreed pharmacopoeia or customer specification with a COA covering identity, assay, related substances, residual solvents and crystal form; SDS and TDS are supplied, and HPLC or NMR records and registration dossier support can be discussed at inquiry, with EP, USP or JP monograph handling arranged when the order specifies one.
• Agomelatine is sold for pharmaceutical research and production by licensed manufacturers, not for individual patient use. For a quote, UATChem needs the pharmacopoeia or specification, quantity, packing and destination port.

FAQ

Q: What is agomelatine used for?

A: It is a small molecule API in antidepressant tablets for major depressive disorder, for licensed drug makers’ production use.

Q: Does agomelatine have a chiral center?

A: No, agomelatine has no stereocenter, so quality focuses on crystal form, solvents and related substances, not enantiomers.

Q: How is agomelatine packed and documented?

A: It ships in foil bags in fiber drums, light and moisture protected, with a COA for assay and impurities and dossier support.