Dutasteride Related Compounds & Impurities

Dutasteride is a dual 5-alpha-reductase inhibitor (types I and II) that reduces dihydrotestosterone levels, used for benign prostatic hyperplasia.

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 Dutasteride reference standards, pharmacopeial and non-pharmacopeial Dutasteride 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 Dutasteride-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

Dutasteride
Dutasteride EP Impurity F
Dutasteride EP Impurity G
Dutasteride EP Impurity I
Dutasteride Dihydro Impurity
Dutasteride EP Impurity A
Dutasteride Methyl Ester Impurity
Dutasteride Ethyl Ester Impurity
Dutasteride 17 alpha-5-ene
Dutasteride 17 Alpha Epimer
Dutasteride EP Impurity B
Dutasteride Impurity C
Dutasteride EP Impurity H
Dutasteride EP Impurity E
5-beta-Dutasteride
2,5-bis-(trifluoromethyl)aniline
Dutasteride EP Impurity D
Dutasteride Alpha Acid
Dutasteride Impurity 12
Desmethyl-6,8,10-triene Dutasteride
3,4-bis(trifluoromethyl)aniline
Desmethyl-6,8,10-triene Dutasteride
Dutasteride Impurity N
Dutasteride Nitroso Impurity
4`-Hydroxy Dutasteride
17beta-Carboxy-5-oxo-A-nor-3,5-secoandrostan-3-oic Acid
Dutasteride Impurity 10
Dutasteride Impurity 11
Dutasteride Impurity 2
Dutasteride Impurity 1

Isotope Labelled Compounds

Dutasteride-13C6
Dutasteride D3