PHR1385

Ketoconazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): Ketoconazole, (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine
• Fórmula empírica (Notação de Hill): C₂₆H₂₈Cl₂N₄O₄
• Número CAS: 65277-42-1
• Peso molecular: 531.43
• Número CE: 265-667-4
• Número MDL: MFCD00058579
• Código UNSPSC: 41116107
• ID de substância PubChem: 329823362
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. K0600000; traceable to USP 1356508
• família API: ketoconazole
• Certificado de análise (CofA): current certificate can be downloaded
• técnica(s): HPLC: suitable; gas chromatography (GC): suitable
• aplicação(ões): pharmaceutical (small molecule)
• Formato: neat
• temperatura de armazenamento: 2-30°C
• cadeia de caracteres SMILES: CC(=O)N1CCN(CC1)c2ccc(OC[C@H]3CO[C@@](Cn4ccnc4)(O3)c5ccc(Cl)cc5Cl)cc2
• InChI: 1S/C26H28Cl2N4O4/c1-19(33)31-10-12-32(13-11-31)21-3-5-22(6-4-21)34-15-23-16-35-26(36-23,17-30-9-8-29-18-30)24-7-2-20(27)14-25(24)28/h2-9,14,18,23H,10-13,15-17H2,1H3/t23-,26-/m0/s1
• chave InChI: XMAYWYJOQHXEEK-OZXSUGGESA-N

Descrição

Descrição geral

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.
Ketoconazole is an imidazole antifungal agent administered through topical or oral means. It is used for the treatment of chronic mucocutaneous candidiasis, fungal infections of the gastro-intestinal tract, dermatophyte infections, systemic infections, and fungal infections in immuno-compromised patients.

Aplicação

CYP3A4 inhibitor

Ketoconazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography 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.

Ações bioquímicas/fisiológicas

Antifungal agent

Nota de análise

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

Outras 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.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAC3465 in the slot below. This is an example certificate only and may not be the lot that you receive.

Informações de segurança

• Pictogramas: GHS06,GHS08,GHS09
• Palavra indicadora: Danger
• Frases de perigo: H301,H360F,H373,H410
• Declarações de precaução: P202 - P260 - P264 - P273 - P280 - P301 + P310
• Classificações de perigo: Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 2
• Código de classe de armazenamento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable