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Key Documents

PHR1757

Supelco

Nevirapine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Nevirapine, 11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one

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About This Item

Formule empirique (notation de Hill):
C15H14N4O
Numéro CAS:
Poids moléculaire :
266.30
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to Ph. Eur. Y0000520
traceable to USP 1460703

Famille d'API

nevirapine

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 g

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

CC1=CC=NC2=C1NC(C(C=CC=N3)=C3N2C4CC4)=O

InChI

1S/C15H14N4O/c1-9-6-8-17-14-12(9)18-15(20)11-3-2-7-16-13(11)19(14)10-4-5-10/h2-3,6-8,10H,4-5H2,1H3,(H,18,20)

Clé InChI

NQDJXKOVJZTUJA-UHFFFAOYSA-N

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Description générale

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 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 suppressing the multiplication of HIV. It is highly effective against the advanced HIV disease.

Application

Nevirapine may be used as a pharmaceutical reference standard for the determination 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.

Actions biochimiques/physiologiques

Nevirapine is an allosteric, non-nucleoside inhibitor of HIV reverse transcriptase (NNRTI). The Ki for inhibition of wild-type RT by Nevirapine is 200 nM.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAA8118 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

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.

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 2

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

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Les clients ont également consulté

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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)
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)
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)

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