PHR1385

Ketoconazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonim(y): Ketoconazole, (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine
• Wzór empiryczny (zapis Hilla): C₂₆H₂₈Cl₂N₄O₄
• Numer CAS: 65277-42-1
• Masa cząsteczkowa: 531.43
• NACRES: NA.24
• PubChem Substance ID: 329823362
• UNSPSC Code: 41116107
• EC Number: 265-667-4
• MDL number: MFCD00058579

Właściwości

• Quality Segment: 300
• grade: certified reference material, pharmaceutical secondary standard
• agency: traceable to Ph. Eur. K0600000, traceable to USP 1356508
• API family: ketoconazole
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable, gas chromatography (GC): suitable
• application(s): pharmaceutical; pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: 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
• InChI key: XMAYWYJOQHXEEK-OZXSUGGESA-N

Opis

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.
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.

Application

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

CYP3A4 inhibitor

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

Antifungal agent

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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.

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.

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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS06,GHS08,GHS09
• Słowo ostrzegawcze: Danger
• Kody zagrożeń: H301,H360F,H373,H410
• Ostrzeżenia: P202 - P260 - P264 - P273 - P280 - P301 + P310
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 2
• Klasa składowania: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Co się dzieje?: WGK 3
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable