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Ketoconazole USP BP Ph Eur EP JP Grade Supplier Exporter Manufacturers' Representative

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Ketoconazole
CAS Number: 65277-42-1

Molecular Formula: C26H28Cl2N4O4
Molecular Weight: 531.43

Ketoconazole Suppliers
Ketoconazole

Ketoconazole is an antiandrogen, antifungal, and antiglucocorticoid medication used to treat several fungal infections. It works by killing the fungus or yeast or preventing its growth.

Ketoconazole USP Grade Specifications:
C26H28Cl2N4O4 --- 531.43
Piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis-;
(±)-cis-1-Acetyl-4-(p-[[2-(2,4-dichlorophenyl)-2-(imidazol-1- ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl)piperazine
CAS 65277-42-1
UNII: R9400W927I

DEFINITION
Ketoconazole contains NLT 98.0% and NMT 102.0% of ketoconazole (C26H28Cl2N4O4 ), calculated on the dried basis.

IDENTIFICATION
A
. Infrared Absorption.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography system.
Optical Rotation, Specific Rotation:
Sample solution: 40 mg/mL in methanol
Acceptance criteria: −1° to +1° at 20C.
Loss on Drying: Dry under vacuum at 80C for 4 h. Acceptance criteria:  NMT 0.5%
Packaging and Storage: Preserve in well-closed containers.


Ketoconazole is also available as per BP Ph Eur EP JP monograph.

Please visit SDS Safety Data Sheet of Ketoconazole Suppliers.

American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.

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Suppliers and Manufacturers' Representative:
American Molecules - Ammol.org USA
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org

17 April, 2025