Agomelatine, identified by CAS number 138112-76-2, stands as a notable pharmaceutical raw material in the landscape of modern antidepressant therapy. Available as a high-purity powder, typically exceeding 99% assay, this compound is critical for the synthesis of finished dosage forms used in treating major depressive disorder (MDD) and other mood-related conditions linked to circadian dysregulation.

Unlike traditional antidepressants that primarily target serotonin, norepinephrine, or dopamine reuptake, Agomelatine operates through a unique mechanism. It acts as a potent agonist at melatonergic receptors (MT and MT) and simultaneously as an antagonist at the 5-HT2C serotonin receptor. This dual action is key to its therapeutic effect, particularly its ability to resynchronize disturbed circadian rhythms, which are often implicated in the pathology of depression and seasonal affective disorder.

Chemically, Agomelatine is N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide, with a molecular formula of C15H17NO2 and a molecular weight of 243.306 g/mol. In its raw material form, it appears as a white to off-white crystalline powder. Key physical properties include a melting point typically ranging from 107-109°C, a boiling point around 478.8°C at 760 mmHg, and a density of approximately 1.109 g/cm³. Its significant lipophilicity, indicated by a logP of 2.8, facilitates its ability to cross the blood-brain barrier and exert its effects within the central nervous system.

The therapeutic advantages of Agomelatine highlighted in clinical studies include not only efficacy in reducing depressive symptoms but also specific benefits related to sleep architecture improvement. Compared to some other antidepressants, Agomelatine has demonstrated a favorable profile regarding body weight and sexual function, issues that can contribute to poor patient adherence with conventional treatments. Furthermore, evidence suggests a relatively rapid onset of action in some patients, with symptom relief potentially observed within two weeks.

Producing pharmaceutical-grade Agomelatine powder demands stringent quality control measures. High-performance liquid chromatography (HPLC) is the standard method for assaying purity, ensuring the powder meets or exceeds the required >99% specification. Control of impurities, especially oxidation-prone variants, is critical, with pharmacopoeial standards like those in EP 10.0 often stipulating limits, typically below 0.2%. Chiral purity is also a vital consideration, ensuring the material is racemate-free to avoid potential adverse effects associated with unwanted stereoisomers. Stability testing is paramount, requiring storage under light-protected conditions to maintain chemical integrity. Furthermore, while generally well-tolerated, healthcare providers prescribing Agomelatine must monitor liver function, underscoring the importance of using only the highest quality, well-characterized raw material.

As a pharmaceutical raw material, the quality of Agomelatine powder directly impacts the safety and efficacy of the final medicinal product. Manufacturers of finished dose forms rely on suppliers who can consistently provide material that meets rigorous pharmacopoeial standards and regulatory requirements. This includes not only chemical purity and physical characteristics but also comprehensive documentation, including Certificates of Analysis (CoA) and supporting quality data.

The demand for high-quality Agomelatine powder is driven by its unique clinical profile and growing adoption as a valuable treatment option for depression, particularly in patients where circadian rhythm disturbance is a significant factor or where side effect profiles of other antidepressants are less favorable. Its application extends beyond MDD to potentially include off-label uses for conditions like generalized anxiety disorder, further increasing the need for a reliable supply chain of the active pharmaceutical ingredient (API).

Ensuring a consistent supply of pharmaceutical raw materials like Agomelatine powder is essential for the global healthcare industry. Reliable partnerships between API manufacturers and pharmaceutical companies are crucial for the continuous production of life-enhancing medications. The process involves not only manufacturing but also rigorous testing, packaging, and logistics to ensure the material arrives at the drug manufacturer's facility in perfect condition, ready for formulation into tablets or other dosage forms.

In summary, Agomelatine powder, CAS 138112-76-2, represents a vital component in the treatment of depressive disorders, offering a unique pharmacological approach centered on circadian rhythm regulation. Its production requires adherence to the highest standards of purity and quality control.

As a dedicated manufacturer and reliable supplier of high-quality Agomelatine powder, NINGBO INNO PHARMCHEM CO.,LTD. is committed to providing pharmaceutical companies with material that meets stringent global standards. For detailed information on the price of Agomelatine powder, comprehensive specifications, or to initiate the process to buy or purchase this essential pharmaceutical raw material, please contact us. Our team is ready to assist with your sourcing needs, ensuring you receive a product of exceptional purity and quality for your pharmaceutical applications.