PHR1385

Ketoconazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinonimo/i: Ketoconazole, (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine
• Formula empirica (notazione di Hill): C₂₆H₂₈Cl₂N₄O₄
• Numero CAS: 65277-42-1
• Peso molecolare: 531.43
• Numero CE: 265-667-4
• Numero MDL: MFCD00058579
• Codice UNSPSC: 41116107
• ID PubChem: 329823362

Proprietà

• Grado: certified reference material; pharmaceutical secondary standard
• Livello qualitativo: 300
• agenzia: traceable to Ph. Eur. K0600000; traceable to USP 1356508
• Famiglia di API: ketoconazole
• CdA: current certificate can be downloaded
• tecniche: HPLC: suitable; gas chromatography (GC): suitable
• applicazioni: pharmaceutical (small molecule)
• Formato: neat
• Temperatura di conservazione: 2-30°C
• Stringa SMILE: 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; XMAYWYJOQHXEEK-OZXSUGGESA-N

Descrizione

Descrizione generale

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.

Applicazioni

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.

CYP3A4 inhibitor

Azioni biochim/fisiol

Antifungal agent

Risultati analitici

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

Altre note

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 a piè di pagina

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.

Informazioni sulla sicurezza

• Pittogrammi: GHS06,GHS08,GHS09
• Avvertenze: Danger
• Indicazioni di pericolo: H301 - H360F - H373 - H410
• Consigli di prudenza: P202 - P260 - P264 - P273 - P280 - P301 + P310
• Classi di pericolo: Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 2
• Codice della classe di stoccaggio: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe di pericolosità dell'acqua (WGK): WGK 3
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable