Itraconazole Related Compounds & Impurities

Itraconazole is a triazole antifungal with broad-spectrum activity against dermatophytes, yeasts and moulds, used for systemic and superficial fungal infections.

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 Itraconazole reference standards, pharmacopeial and non-pharmacopeial Itraconazole 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 Itraconazole-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

Itraconazole
Itraconazole EP Impurity A
Itraconazole EP Impurity B
Itraconazole EP Impurity C
Itraconazole EP Impurity D
Itraconazole EP Impurity E
Itraconazole EP Impurity F
Itraconazole EP Impurity G
Hydroxy Itraconazole
Itraconazole Didioxolanyl Analog
Itraconazole Hydroxy Isobutyltriazolone Impurity
Itraconazole impurity 35
Itraconazole Impurity 16
Itraconazole 4-Triazolyl isomer
Itraconazole Methoxy Nitro Impurity
Itraconazole Impurity 1
Itraconazole Impurity 7
Itraconazole Impurity 28
N-Nitroso Itraconazole Impurity 1
cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-Triazol-1-ylmethyl)-1,3-dioxolan-4-yl methyl chloride
Itraconazole Impurity 32
Itraconazole Impurity 33
Itraconazole Impurity 31
Itraconazole EP Impurity C + D
Des-(2-butyl) N-Allyl Itraconazole
Itraconazole Impurity 12
Itraconazole Impurity 10
Itraconazole Mono N-Oxide
Itraconazole Impurity 17
Itraconazole Impurity 18
Itraconazole Impurity 34
Itraconazole Impurity 13
Itraconazole Impurity 36
Itraconazole Degradation Impurity 2
Nitroso Itraconazole Impurity 2
Itraconazole Impurity 37
Itraconazole Methoxy Triazolone Impurity
Nitroso Itraconazole Impurity 3
Itraconazole Methoxy Butyltriazolone Impurity
Itraconazole Impurity 3

Metabolites

Itraconazole 2-Oxo Metabolite
Itraconazole N-Desalkyl Impurity

Isotope Labelled Compounds

Hydroxy Itraconazole-D8
Itraconazole -D5
Itraconazole-D9
Itraconazole D3