PHR1296

Bifonazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 1-(p,α-Diphenylbenzyl)imidazole
• Empirical Formula (Hill Notation): C₂₂H₁₈N₂
• CAS Number: 60628-96-8
• Molecular Weight: 310.39
• EC Number: 262-336-6
• MDL number: MFCD00865567
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823286
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. B1110000
• API family: bifonazole
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: c1ccc(cc1)C(c2ccc(cc2)-c3ccccc3)n4ccnc4
• InChI: 1S/C22H18N2/c1-3-7-18(8-4-1)19-11-13-21(14-12-19)22(24-16-15-23-17-24)20-9-5-2-6-10-20/h1-17,22H
• InChI key: OCAPBUJLXMYKEJ-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.
Bifonazole is a substituted imidazole analog with therapeutic potential in treating invasive mucosal infections. It exhibits antifungal activity by suppressing the proliferation of dermatophytes, yeasts and fungi affecting the skin and nails. Its mode of action involves blocking the fungal ergosterol biosynthetic pathway and additional inhibition of terpenoid biosynthesis.

Application

Bifonazole may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric technique.

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

Bifonazole is an imidazole-based anti-fungal agent with broad spectrum activity against many fungi, molds, yeast and some Gram-positive bacteria. Bifonazole inhibits ergosterol biosynthetic protein 28 and Cytochrome P450 2B4.

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3256 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS07
• signalword: Warning
• hcodes: H302
• pcodes: P264 - P270 - P301 + P312 + P330 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable