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Key Documents

PHR1760

Supelco

Nevirapine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

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

Formula empirica (notazione di Hill):
C14H14N4O
Numero CAS:
Peso molecolare:
254.29
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to USP 1460725

Famiglia di API

nevirapine

CdA

current certificate can be downloaded

Confezionamento

pkg of 50 mg

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

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)
HDVZWQWXAQRFKJ-UHFFFAOYSA-N

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Descrizione generale

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.

Applicazioni

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.

Risultati analitici

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

Altre note

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 a piè di pagina

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.

Pittogrammi

Skull and crossbonesHealth hazard

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

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

Organi bersaglio

Liver

Codice della classe di stoccaggio

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

Lot/Batch Number

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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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