PHR1385

Ketoconazole

Pharmaceutical Secondary Standard; Certified Reference Material

• 동의어(들): Ketoconazole, (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine
• 실험식(Hill 표기법): C₂₆H₂₈Cl₂N₄O₄
• CAS Number: 65277-42-1
• Molecular Weight: 531.43
• EC Number: 265-667-4
• MDL number: MFCD00058579
• UNSPSC 코드: 41116107
• PubChem Substance ID: 329823362
• NACRES: NA.24

속성

• Grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. K0600000; traceable to USP 1356508
• API family: ketoconazole
• CofA: current certificate can be downloaded
• 기술: HPLC: suitable; gas chromatography (GC): suitable
• 응용 분야: pharmaceutical (small molecule)
• 형식: neat
• 저장 온도: 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

설명

일반 설명

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.

애플리케이션

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

생화학적/생리학적 작용

Antifungal agent

분석 메모

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

기타 정보

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.

각주

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.

안전성 정보

• 픽토그램: GHS06,GHS08,GHS09
• 신호어: Danger
• 유해 및 위험 성명서: H301,H360F,H373,H410
• 예방조치 성명서: P202 - P260 - P264 - P273 - P280 - P301 + P310
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 2
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable