PHR1892

Voriconazole

Pharmaceutical Secondary Standard: Certified Reference Material

• Synonym(s): Voriconazole, 2R,3S-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol, UK-109496
• Empirical Formula (Hill Notation): C₁₆H₁₄F₃N₅O
• CAS Number: 137234-62-9
• Molecular Weight: 349.31
• MDL number: MFCD00905717
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. Y0001395; traceable to USP 1718008
• API family: voriconazole
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• application(s): pharmaceutical
• format: neat
• storage temp.: 2-8°C
• SMILES string: C[C@@H](c1ncncc1F)[C@](O)(Cn2cncn2)c3ccc(F)cc3F
• InChI: 1S/C16H14F3N5O/c1-10(15-14(19)5-20-7-22-15)16(25,6-24-9-21-8-23-24)12-3-2-11(17)4-13(12)18/h2-5,7-10,25H,6H2,1H3/t10-,16+/m0/s1
• InChI key: BCEHBSKCWLPMDN-MGPLVRAMSA-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

Voriconazole is a synthetically prepared, broad-spectrum triazole derivative of fluconazole, which shows in vitro activity against many yeasts and a broad-spectrum of mold and dermatophyte isolates. Its mode of action involves the inhibition of cytochrome P450 (CYP)-dependent enzyme, 14-α-sterol demethylase, and hence it is involved in disrupting the cell membrane and terminate the fungal growth.

Application

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.

Voriconazole may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using high-performance liquid chromatography technique.

Biochem/physiol Actions

Voriconazole is an antifungal used to treat serious fungal infections. Voriconazole inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-α sterol demethylase resulting in a depletion of ergosterol in fungal cell membranes.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC2092 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS06,GHS08
• signalword: Danger
• hcodes: H301,H341,H351,H361,H371,H372,H373,H412
• pcodes: P202 - P260 - P264 - P270 - P273 - P301 + P310
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Chronic 3 - Carc. 2 - Muta. 2 - Repr. 2 - STOT RE 1 - STOT RE 2 Oral - STOT SE 2 Oral
• target_organs: Eyes, Liver,Kidney
• 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