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Key Documents

PHR1731

Supelco

Nitisinone

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Nitisinone, 2-(2-Nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione, 2-[2-Nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione, NTBC, Nitisone, SC 0735

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About This Item

Fórmula empírica (Notação de Hill):
C14H10F3NO5
Número CAS:
Peso molecular:
329.23
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

família API

nitisinone

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 1 g

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

-10 to -25°C

cadeia de caracteres SMILES

[O-][N+](=O)c1cc(ccc1C(=O)C2C(=O)CCCC2=O)C(F)(F)F

InChI

1S/C14H10F3NO5/c15-14(16,17)7-4-5-8(9(6-7)18(22)23)13(21)12-10(19)2-1-3-11(12)20/h4-6,12H,1-3H2

chave InChI

OUBCNLGXQFSTLU-UHFFFAOYSA-N

Informações sobre genes

human ... HPD(3242)

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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. Nitisinone is a medication, effectively used for the treatment and maintainence of alkaptonuria, an autosomal recessive disease. Its mode of action involves the inhibition of second enzyme in the tyrosine pathway, 4-hydroxyphenylpyruvate dioxygenase that produces HGA from 4-hydroxyphenylpyruvate.

Aplicação

Nitisinone may be used as a pharmaceutical reference standard for the quantification of the analyte in phamraceutical formulations using high-performance liquid chromatography technique.
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

Nitisinone is a competitive inhibitor that reversibly inhibits 4-Hydroxyphenylpyruvate oxidase (dioxygenase). Nitisinone is used in the treatment of hereditary tyrosinemia type 1, where it blocks the degradation of tyrosine into harmful substances.

Nota de análise

These secondary standards offer multi-traceability to the USP, EP 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.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAC0575 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Visite a Biblioteca de Documentos

Serum markers in alkaptonuria: simultaneous analysis of homogentisic acid, tyrosine and nitisinone by liquid chromatography tandem mass spectrometry
Hughes TA, et al.
Annals of Clinical Biochemistry, 52(5), 597-605 (2015)
Metabolic effects of increasing doses of nitisinone in the treatment of alkaptonuria
Gertsman I, et al.
JIMD Reports, 13(20), 57-57 (2015)
A stability indicating HPLC method for the determination of nitisinone in capsules
Souri E, et al.
Indian Journal of Pharmaceutical Sciences, 77(3), 348-348 (2015)
Shuzhang Yang et al.
Proceedings of the National Academy of Sciences of the United States of America, 116(44), 22229-22236 (2019-10-16)
Fumarylacetoacetate hydrolase (FAH) is the last enzyme in tyrosine catabolism, and mutations in the FAH gene are associated with hereditary tyrosinemia type I (HT1 or TYRSN1) in humans. In a behavioral screen of N-ethyl-N-nitrosourea mutagenized mice we identified a mutant

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