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Description Back to Top
Fluconazole, USP is used to treat and prevent superficial and systematic fungal infections. Known as a triazole antifungal drug, it has a white crystalline appearance and is slightly soluble in water and alcohol. Most commonly found under the trade names Diflucan and Trican and is listed on the World Health Organizations list of essential medicines. Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
1-(2,4-Difluorophenyl)-1-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol ; 2,4-Difluoro-1,1-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl Alcohol ; 2,4-Difluoro-alpha,alpha-1-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl Alcohol ; 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol;
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
ASSAY (DRIED BASIS) | 98.0 | 102.0 % |
LOSS ON DRYING | 0.5 % | |
RESIDUE ON IGNITION | 0.1 % | |
ORGANIC IMPURITIES: | ||
FLUCONAZOLE RELATED COMPOUND A | 0.2 % | |
SPECIFIED IMPURITY | 1.0 % | |
FLUCONAZOLE RELATED COMPOUND B | 0.1 % | |
FLUCONAZOLE RELATED COMPOUND C | 0.2 % | |
Any individual unspecified impurity | 0.1 % | |
TOTAL UNKOWN IMPURITIES | 0.3 % | |
TOTAL IMPURITIES | 1.5 % | |
ELEMENTAL IMPURITIES | AS REPORTED | |
IDENTIFICATION (A) | TO PASS TEST | |
IDENTIFICATION (B) | TO PASS TEST | |
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | TO PASS TEST |
Shipping & Storage Back to Top