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Key Documents

PHR1160

Supelco

Fluconazole

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol

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About This Item

Fórmula empírica (Notação de Hill):
C13H12F2N6O
Número CAS:
Peso molecular:
306.27
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to BP 1174
traceable to Ph. Eur. Y0000557
traceable to USP 1271700

família API

fluconazole

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

FC1=CC(F)=C(C(CN2N=CN=C2)(O)CN3N=CN=C3)C=C1

InChI

1S/C13H12F2N6O/c14-10-1-2-11(12(15)3-10)13(22,4-20-8-16-6-18-20)5-21-9-17-7-19-21/h1-3,6-9,22H,4-5H2

chave InChI

RFHAOTPXVQNOHP-UHFFFAOYSA-N

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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.
Fluconazole is an antifungal agent with broad-spectrum antimicrobial activity. It is employed for the remediation of oral, esophagal and vaginal candidiasis and other serious systemic candidal infections. The drug is also effective against meningitis caused by Cryptococcus neoformans.

Aplicação

Fluconazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometry 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

Fluconazole is an antifungal agent. It is highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethyllation. Fluconazole is a potent inhibitor of CYP2C9. Fluconazole interferes with fungal ergosterol synthesis and downregulates the metallothionein gene.

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.
Values of analytes vary lot to lot.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAC0255 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produtos recomendados

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictogramas

Health hazardExclamation mark

Palavra indicadora

Danger

Frases de perigo

Classificações de perigo

Acute Tox. 4 Oral - Aquatic Chronic 3 - Lact. - Repr. 1B

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


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Certificados de análise (COA)

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Evaluation of the bioequivalence of capsules containing 150 mg of fluconazole
Porta V, et al.
International Journal of Pharmaceutics, 288(1), 81-86 (2005)
QUANTITATIVE DETERMINATION OF FLUCONAZOLE IN SYRUPS BY FIRST ORDER DERIVATIVE SPECTROPHOTOMETRY
Aboul-Enein HY, et al.
Analytical Letters, 35(7), 1193-1204 (2002)
QUANTITATIVE DETERMINATION OF FLUCONAZOLE IN CAPSULES AND IV SOLUTIONS BY UV SPECTROPHOTOMETRIC METHODS
Go?er NG, et al.
Analytical Letters, 34(12), 2089-2098 (2001)
Joseph H Skalski et al.
PLoS pathogens, 14(9), e1007260-e1007260 (2018-09-21)
The gastrointestinal microbiota influences immune function throughout the body. The gut-lung axis refers to the concept that alterations of gut commensal microorganisms can have a distant effect on immune function in the lung. Overgrowth of intestinal Candida albicans has been
Marcio Nucci et al.
PloS one, 8(3), e59373-e59373 (2013-03-26)
The epidemiology of candidemia varies depending on the geographic region. Little is known about the epidemiology of candidemia in Latin America. We conducted a 24-month laboratory-based survey of candidemia in 20 centers of seven Latin American countries. Incidence rates were

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