Dapoxetine Hydrochloride Related Compounds & Impurities

Dapoxetine Hydrochloride is a short-acting SSRI specifically developed and licensed for on-demand treatment of premature ejaculation, with rapid absorption enabling use as needed 1-3 hours before intercourse.

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 Dapoxetine Hydrochloride reference standards, pharmacopeial and non-pharmacopeial Dapoxetine Hydrochloride 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 Dapoxetine Hydrochloride-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

Dapoxetine Hydrochloride
Dapoxetine
N-Desmethyl Dapoxetine HCl
Dapoxetine R Isomer
Dapoxetine N-Oxide
Dapoxetine N-Oxide hydrochloride
N-Didesmethyl Dapoxetine Hydrochloride
Dapoxetine Hydroxy Impurity
Dapoxetine impurity A
Racemic mixture of dapoxetine Hydrochloride
Dapoxetine Hydrochloride Impurity 1
rac N-Demethyl Dapoxetine
Dapoxetine impurity 12
Dapoxetine Impurity 2
Dapoxetine Impurity 4
Dapoxetine Impurity 5
((S)-3-(Naphthalen-1-yloxy)-1-phenyl-propan-1-ol)
3-(4-(3-(dimethylamino)-3-phenylpropoxy)naphthalen-1-yl)-1-phenylpropan-1-one hydrochoride
Dapoxetine Impurity 8
rac N-Nitroso-N-Desmethyl Dapoxetine
Dapoxetine Impurity 24
(R)-Dapoxetine
Dapoxetine Impurity 11

Isotope Labelled Compounds

Dapoxetine-D7 Hydrochloride
Rac N-Demethyl Dapoxetine D3 Hydrochloride
Dapoxetine-d6 Hydrochloride
rac-N-Desmethyl Dapoxetine-D7 Hydrochloride