PHR1160

Fluconazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
• Empirical Formula (Hill Notation): C₁₃H₁₂F₂N₆O
• CAS Number: 86386-73-4
• Molecular Weight: 306.27
• MDL number: MFCD00274549
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823177
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 1174; traceable to Ph. Eur. Y0000557; traceable to USP 1271700
• API family: fluconazole
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: FC1=CC(F)=C(C(CN2N=CN=C2)(O)CN3N=CN=C3)C=C1
• InChI: 1S/C13H12F2N6O/c14-10-1-2-11(12(15)3-10)13(22,4-20-8-16-6-18-20)5-21-9-17-7-19-21/h1-3,6-9,22H,4-5H2
• InChI key: RFHAOTPXVQNOHP-UHFFFAOYSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Fluconazole is an antifungal agent with broad-spectrum antimicrobial activity. It is employed for the remediation of oral, esophagal and vaginal candidiasis and other serious systemic candidal infections. The drug is also effective against meningitis caused by Cryptococcus neoformans.

Application

Fluconazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometry techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Fluconazole is an antifungal agent. It is highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethyllation. Fluconazole is a potent inhibitor of CYP2C9. Fluconazole interferes with fungal ergosterol synthesis and downregulates the metallothionein gene.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Values of analytes vary lot to lot.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0255 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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Safety Information

• pictograms: GHS08,GHS07
• signalword: Danger
• hcodes: H302,H360D,H362,H412
• pcodes: P202 - P260 - P263 - P273 - P301 + P312 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Chronic 3 - Lact. - Repr. 1B
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable