Ketoconazole

SIAL/PHR1385 - Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: Ketoconazole; (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine

CAS Number: 65277-42-1
Empirical Formula (Hill Notation): C₂₆H₂₈Cl₂N₄O₄
Molecular Weight: 531.43
EC Number: 265-667-4
MDL Number: MFCD00058579
Linear Formula: C₂₆H₂₈Cl₂N₄O₄
Product Type: Chemical

Catalog Number	PKG Qty.	Price


45-PHR1385-1G	1 g	$97.50 1/EA	Add To Favorites

Properties
Descriptions
Safety Info.
Basic Data

agency	traceable to Ph. Eur. K0600000
	traceable to USP 1356508
API family	ketoconazole
application(s)	pharmaceutical (small molecule)
CofA	current certificate can be downloaded
format	neat
grade	certified reference material
	pharmaceutical secondary standard
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
Quality Level	300
SMILES string	CC(=O)N1CCN(CC1)c2ccc(OC[C@H]3CO[C@@](Cn4ccnc4)(O3)c5ccc(Cl)cc5Cl)cc2
storage temp.	2-30°C
technique(s)	gas chromatography (GC): suitable
	HPLC: suitable

Analysis Note:	These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.
Application:	CYP3A4 inhibitor
Application:	Ketoconazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
Application:	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
Footnote:	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.
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.
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.

Symbol	GHS06,GHS08,GHS09
Signal word	Danger
Hazard statements	H301 - H360F - H373 - H410
Precautionary statements	P201 - P273 - P301 + P310 + P330
Hazard Codes	T,N
Risk Statements	60-25-48/22-50/53
Safety Statements	53-45-60-61
RIDADR	UN2811 - class 6.1 - PG 3 - EHS - Toxic solids, organic, n.o.s.,
WGK Germany	WGK 3
Flash Point(F)	Not applicable
Flash Point(C)	Not applicable

Storage Temp.	2-30°C
UNSPSC	41116107

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