Fluoxetine Hydrochloride Related Compounds & Impurities

Fluoxetine Hydrochloride is a selective serotonin reuptake inhibitor (SSRI) used for major depression, obsessive-compulsive disorder, bulimia nervosa and panic disorder.

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

Fluoxetine Hydrochloride
4-chlorobenzotrifluride
Fluoxetine EP Impurity A
Fluoxetine Impurity D
Fluoxetine EP Impurity B
Fluoxetine EP Impurity B Hydrochloride
Fluoxetine EP Impurity C
Fluoxetine Succinamic Acid
Norfluoxetine Hydrochloride
Fluoxetine Impurity 6
N-Methyl-3-chloropropylamine Hydrochloride
N-Methyl Fluoxetine
Fluoxetine -2 isomer
4,4`-Dichlorobenzophenone
3-[(3-hydroxy-3-phenylpropyl)methyl amino]-1-phenylpropan-1-ol
3-(Methylamino)-1-(4-methylphenyl)propan-1-ol
N-formyl fluoxetine
3-(benzyl(methyl)amino)-1-phenylpropan-1-ol
3-[Benzyl(methyl)amino]-1-phenylpropan-1-one
3-Chloro-1-(4-methylphenyl)propan-1-ol
N,N-Dimethyl-3-(4-trifluoromethyl)phenoxy propan-1-amine
N-Methyl Fluoxetine Hydrochloride
N-Nitroso-Fluoxetine
Fluoxetine Nitroso EP Impurity A
3-(3-Chlorophenyl)propan-1-ol
Fluoxetine EP Impurity B
Fluoxetine Impurity 8
Fluoxetine Nitroso EP Impurity C
N-Nitroso Fluoxetine EP Impurity B
Fluoxetine Impurity 1
Fluoxetine Impurity 13
Lactose-Fluoxetine Amadori Rearrangement Product
(S)-Fluoxetine Hydrochloride
Fluoxetine Lactose Adduct (Racemic mixture )
Fluoxetine Impurity 18
Fluoxetine Hydrochloride
Fluoxetine Impurity 2
Fluoxetine Impurity 3
Fluoxetine Impurity 4
Fluoxetine Hydrochloride impurity 1

Metabolites

Fluoxetine N-Glucuronide Sodium Salt

Isotope Labelled Compounds

Fluoxetine-D5 Oxalate
Norfluoxetine-D5 Hydrochloride
Fluoxetine-D5 Hydrochloride
Fluoxetine-D5
Fluoxetine-D6
N-Nitroso Fluoxetine D5