Duloxetine Hydrochloride Related Compounds & Impurities

Duloxetine Hydrochloride is a serotonin-noradrenaline reuptake inhibitor (SNRI) used for major depressive disorder, generalised anxiety, diabetic neuropathic pain and fibromyalgia.

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

Duloxetine impurity 22
Duloxetine Hydrochloride
Duloxetine Hydrochloride EP Impurity A
Duloxetine EP Impurity B
Duloxetine EP Impurity C
Duloxetine EP Impurity C Hydrochloride
Duloxetine EP Impurity D
Duloxetine EP Impurity E
Duloxetine EP Impurity E Hydrochloride
Duloxetine EP Impurity F Hydrochloride
Duloxetine EP Impurity F
Duloxetine EP Impurity F tartarate Salt
Duloxetine EP Impurity G
Duloxetine Impurity A
Duloxetine Impurity B
rac-Duloxetine Hydrochloride
Duloxetine Phenyl Carbamate
(S)-Duloxetine Succinamide
(S)-Duloxetine Phthalamide
Duloxetine Lactose Adduct Impurity
Duloxetine S-Hydroxy Impurity
Duloxetine R-Hydroxy Impurity
Duloxetine N-formyl Impurity
Duloxetine Impurity 6
Duloxetine Impurity 1
Duloxetine Impurity 5
Duloxetine R-isomer
Duloxetine Impurity 4
Duloxetine Impurity 7
N-methyl-3-hydroxy-3-(2-thienyl)propyl amine
Duloxetine Imp J (IH)
N-Methyl-3-(1-naphthalenyloxy)-3-(3-thienyl) propanamine
Duloxetine Impurity 21
Duloxetine Impurity 18
3-(Dimethylamino)-1-(2-thienyl)-1-propanone Hydrochloride
Duloxetine Impurity 11
(±)-alpha-2-(Dimethylamino)ethyl-3-thiophenemethanol
4-Hydroxy Duloxetine B-D-Glucuronide
5-Hydroxy-6-methoxy Duloxetine sulfate
Duloxetine N-Desmethyl (S)-Isomer
Duloxetine Nitroso Impurity 1
Duloxetine Nitroso Impurity 2
Duloxetine Impurity 13
N-Nitroso Duloxetine EP Impurity B
N-Nitroso Duloxetine
Duloxetine EP Impurity F
N-Methyl Duloxetine Oxalate
Duloxetine Impurity 3
Nitroso Doluxetin EP Impurity C
Nitroso Doluxetin EP Impurity E
Nitroso Doluxetin EP Impurity F
Duloxetine Chloro Impurity
Duloxetine Impurity 26
rac Duloxetine 3-Thiophene Isomer Hydrochloride
(R)-3-Methyl-1-(thiophene-2-yl) propan-1-ol
Duloxetine Hydrochloride Impurity 1
Duloxetine EP Impurity A
N,N-Dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
4-Hydroxy Duloxetine
Duloxetine Impurity C Hydrobromide Salt
5-Hydroxy Duloxetine
Duloxetine Nitroso Impurity 3
Duloxetine Nitroso Impurity 4
Duloxetine D7
N-Nitroso Duloxetine EP Impurity A
Duloxetine Nitroso Impurity 5 (Racemic)
6-Hydroxy Duloxetine
4-Hydroxy Duloxetine Acetate
rac Duloxetine 3-Thiophene Isomer
Duloxetine Impurity 29 Hydrochloride
Duloxetine Related Compound F
N-(Acetyl) Duloxetine
Duloxetine Impurity 8
Duloxetine Impurity 2
Duloxetine Impurity 9

Metabolites

4-Hydroxy Duloxetine Beta-D-Glucuronide Sodium Salt
4-Hydroxy Duloxetine Glucuronide Sodium

Isotope Labelled Compounds

Duloxetine-D5 Oxalate
Duloxetine D3 Hydrochloride
Duloxetine-D7 Hydrochloride
rac-Duloxetine D3 Oxalate
N-Nitroso Duloxetine D3 (Racemic mixture)
(±)-Duloxetine-D5 Oxalate
Duloxetine-D3 Oxalate
N-Nitroso Duloxetine-D7
Duloxetine-D3 Maleate
Duloxetine-d7 Maleate
(S)-Duloxetine Phthalamide sodium salt