PHR1160

Fluconazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
• Formule empirique (notation de Hill): C₁₃H₁₂F₂N₆O
• Numéro CAS: 86386-73-4
• Poids moléculaire : 306.27
• Numéro MDL: MFCD00274549
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823177
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to BP 1174; traceable to Ph. Eur. Y0000557; traceable to USP 1271700
• Famille d'API: fluconazole
• CofA (certificat d'analyse): current certificate can be downloaded
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-30°C
• Chaîne SMILES: 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
• Clé InChI: RFHAOTPXVQNOHP-UHFFFAOYSA-N

Description

Description générale

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.

Actions biochimiques/physiologiques

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Produits recommandés

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Informations sur la sécurité

• Pictogrammes: GHS08,GHS07
• Mention d'avertissement: Danger
• Mentions de danger: H302,H360D,H362,H412
• Conseils de prudence: P202 - P260 - P263 - P273 - P301 + P312 - P308 + P313
• Classification des risques: Acute Tox. 4 Oral - Aquatic Chronic 3 - Lact. - Repr. 1B
• Code de la classe de stockage: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable