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Key Documents

PHR1760

Supelco

Nevirapine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

11-Ethyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one, 5,11-DIHYDRO-6H-11-ETHYL- 4-METHYL-DIPYRIDO[3,2-b:2’,3’- e][1,4]DIAZEPIN-6-ONE

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About This Item

Fórmula empírica (Notação de Hill):
C14H14N4O
Número CAS:
Peso molecular:
254.29
Código UNSPSC:
41116107
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to USP 1460725

família API

nevirapine

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 50 mg

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-30°C

InChI

1S/C14H14N4O/c1-3-18-12-10(5-4-7-15-12)14(19)17-11-9(2)6-8-16-13(11)18/h4-8H,3H2,1-2H3,(H,17,19)

chave InChI

HDVZWQWXAQRFKJ-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. Nevirapine Related Compound A is an impurity of nevirapine. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), which belongs to the class of antiretroviral drugs. It acts by inhibiting the reverse transcriptase enzyme, thus stopping the multiplication of HIV. It is highly effective against advanced HIV disease.

Aplicação

Nevirapine may be used as a pharmaceutical reference standard for the analysis of the analyte in pharmaceutical formulations and fixed dose combinations by chromatography.
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.

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 LRAA8553 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Skull and crossbonesHealth hazard

Palavra indicadora

Danger

Frases de perigo

Classificações de perigo

Acute Tox. 3 Oral - Skin Sens. 1 - STOT RE 2 Inhalation

Órgãos-alvo

Liver

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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Encontre a documentação dos produtos que você adquiriu recentemente na biblioteca de documentos.

Visite a Biblioteca de Documentos

Simultaneous determination of lamivudine, stavudine and nevirapine in antiretroviral fixed dose combinations by high performance liquid chromatography
Kapoor N, et al.
Analytica Chimica Acta, 570(1), 41-45 (2006)
Development and validation of a simple and rapid capillary zone electrophoresis method for determination of nnrti nevirapine in pharmaceutical formulations
Zanolli F, et al.
Journal of the Brazilian Chemical Society, 22(10), 2005-2012 (2011)
MEKC determination of antiretroviral reverse transcriptase inhibitors lamivudine, stavudine, and nevirapine in pharmaceutical formulations
Sekar R and Azhaguvel S
Chromatographia, 67(5-6), 389-398 (2008)
Nevirapine
USP42-NF37
United States Pharmacopeia/National Formulary, 32(3), 3101-3101 (2018)

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