PHR1163

(±)-Miconazole nitrate salt

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinónimos: 1-(2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl)imidazole
• Fórmula empírica (notación de Hill): C₁₈H₁₄Cl₄N₂O · HNO₃
• Número de CAS: 22832-87-7
• Peso molecular: 479.14
• Número CE: 245-256-6
• Número MDL: MFCD00058161
• Código UNSPSC: 41116107
• ID de la sustancia en PubChem: 329823180
• NACRES: NA.24

Propiedades

• grado: certified reference material; pharmaceutical secondary standard
• Nivel de calidad: 300
• Agency: traceable to BP 253; traceable to Ph. Eur. M1900000; traceable to USP 1443500
• familia API: miconazole
• CofA: current certificate can be downloaded
• técnicas: HPLC: suitable; gas chromatography (GC): suitable
• aplicaciones: pharmaceutical (small molecule)
• Formato: neat
• temp. de almacenamiento: 2-30°C
• cadena SMILES: ClC1=CC(Cl)=CC=C1C(OCC2=CC=C(Cl)C=C2Cl)CN3C=CN=C3.[O-][N+](O)=O
• InChI: 1S/C18H14Cl4N2O.HNO3/c19-13-2-1-12(16(21)7-13)10-25-18(9-24-6-5-23-11-24)15-4-3-14(20)8-17(15)22;2-1(3)4/h1-8,11,18H,9-10H2;(H,2,3,4)
• Clave InChI: MCCACAIVAXEFAL-UHFFFAOYSA-N

Descripción

Descripción general

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. Miconazole nitrate is an imidazole derivative and a broad spectrum antifungal drug used in the management of fungal outbreak in humans and veterinary animals.[1]

Aplicación

Miconazole nitrate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various techniques.[1][2][3]

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.

Acciones bioquímicas o fisiológicas

Antifungal azole. Mode of action: Inhibits cytochrome P450-dependent 14α-demethylase, which is critical to ergosterol biosynthesis. The accumulated 14α-methylated sterols change the membrane structure of sensitive fungi, resulting in an altered cell membrane permeability. Also inhibits peroxidases, which results in accumulation of peroxide within the cell.

Miconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary for ergosterol biosynthesis. The inhibition of ergosterol results in increased cellular permeability causing leakage of cellular contents. Miconazole may also inhibit endogenous respiration, interact with phospholipids in the cell membrane, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and interfere with triglyceride and phospholipid biosynthesis.

Nota de análisis

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

Otras notas

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.

Nota al pie de página

To see an example of a Certificate of Analysis for this material enter LRAC3325 in the slot below. This is an example certificate only and may not be the lot that you receive.

Productos recomendados

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.

Información de seguridad

• Pictogramas: GHS07
• Palabra de señalización: Warning
• Frases de peligro: H302,H317
• Consejos de prudencia: P280 - P301 + P312 + P330 - P302 + P352
• Clasificaciones de peligro: Acute Tox. 4 Oral - Skin Sens. 1
• Código de clase de almacenamiento: 11 - Combustible Solids
• Clase de riesgo para el agua (WGK): WGK 3
• Punto de inflamabilidad (°F): Not applicable
• Punto de inflamabilidad (°C): Not applicable