Ketoconazole Related Compounds & Impurities

Ketoconazole is an imidazole antifungal that inhibits CYP51 and steroidogenic enzymes, used topically for dermatophytosis and seborrhoeic dermatitis.

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 Ketoconazole reference standards, pharmacopeial and non-pharmacopeial Ketoconazole 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 Ketoconazole-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

Ketoconazole
Ketoconazole Impurity D
Ketoconazole Impurity B
Ketoconazole Impurity C
Ketoconazole EP Impurity E
Ketoconazole Impurity 11
trans-[2-Bromomethyl-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl]methyl Benzoate
Ketoconazole N-Oxide
Ketoconazole Impurity 1
N,N-Diamylnitrosamine
Ketoconazole Hydroxymethyl Impurity
Ketoconazole EP Impurity A
Ketoconazole Impurity 3
Ketoconazole Impurity 10
KetoconazoleHydroxymethyl Impurity
Trans-[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methanol
Ketoconazole Impurity 17
Cis-bromo mesylate
Cis-tosylate Ketoconazole
1-(4-(4-((2-((1H-imidazol-1-yl)methyl)-2-(2-chlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)ethano
Ketoconazole Impurity 20
Cis Tosylate
Ketoconazole Impurity 15
Ketoconazole Impurity 22
Levoketoconazole
Ketoconazole Impurity 21
Ketoconazole Impurity 19
Ketoconazole Nitroso EP Impurity D
4-(4-nitrosopiperazin-1-yl)Phenol
Ketoconazole Impurity 11
Ketoconazole Impurity 12
Ketoconazole N-Oxide Impurity
Ketoconazole Impurity 2
Ketoconazole Impurity 26
Ketoconazole Impurity 27
Ketoconazole Impurities Mixture 1:1:1
Ketoconazole Impurity 32
Ketoconazole Impurity 31
Ketoconazole Hydroxy Impurity
Ketoconazole Impurity 33
Ketoconazole Impurity 34
Ketoconazole Impurity 35
Ketoconazole N-Oxide Impurity 1
Levoketoconazole N-Oxide
Ketoconazole Impurity 4
Ketoconazole impurity 5
Ketoconazole impurity 6

Metabolites

Ketoconazole Glucuronide

Isotope Labelled Compounds

Ketoconazole D3
Levoketoconazole D3
Ketoconazole D4
Ketoconazole D8