Agomelatine Related Compounds & Impurities

Agomelatine is a melatonergic MT1/MT2 agonism with 5-HT2C antagonism, regulate circadian-rhythm normalising effects with a favourable tolerability profile.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Agomelatine reference standards, pharmacopeial and non-pharmacopeial Agomelatine impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Agomelatine-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Agomelatine
Agomelatine Impurity 10 Hydrobromide
Agomelatine Dimer Urea
Agomelatine Impurity 8
Agomelatine Impurity 9
Agomelatine Impurity 11
7-Methoxy-1-naphthaleneethanol
Agomelatine Phosphate Salt
N-[2-(7-Methoxy-1-naphthyl)ethyl]formamide-phosphoric acid
Agomelatine Impurity 2
Agomelatine Impurity 16
Agomelatine Impurity 5 Hydrochloride
Agomelatine Impurity 1
Agomelatine Impurity 13
7-Methoxy-1-Tetralone
Agomelatine Impurity 6
Agomelatine Impurity 14
Agomelatine Impurity 3
Agomelatine Impurity 15
2-(7-methoxynaphthalen-1-yl)-N-(2-(7-methoxynaphthalen-1-yl)ethyl)acetamide
Agomelatine Impurity 10
6-methoxy-1,2,3,4-tetrahydronaphthalen-2-ol
2-(7-methoxynaphthalen-1-yl)-N-(2-(7-methoxynaphthalen-1-yl)ethyl)acetimidamide
7-Methoxy-1-naphthalenol
1,2,3,4-Tetrahydro-7-methoxy-1-naphthalenol 1-Acetate
Agomelatine Impurity 7
1-(2-aminoethyl)-7-methoxy-1,2,3,4-tetrahydronaphthalene
N-Deacetyl-N-Formyl Agomelatine
3-(4-Methoxybenzoyl)propionic Acid
4-(4-methoxyphenyl)butanoic acid
Agomelatine Urea
Nitroso-2-(7-methoxy-1-naphthyl)-N-[2-(7-methoxy-1-naphthyl)ethyl]ethylamine
Agomelatine Impurity C
bis(2-(7-methoxynaphthalen-1-yl)ethyl)amine hydrochloride
N-Nitroso Agomelatine
Agomelatine Impurity 10 Hydrochloride
Agomelatine Impurity 18
Agomelatine Citric Acid
Agomelatine Hydrochloride
Agomelatine Impurity I
Agomelatine Impurity 4

Isotope Labelled Compounds

Agomelatine D6
3-Hydroxy agomelatine D3