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Merck
CN

PHR1760

奈韦拉平相关化合物A

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

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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关于此项目

经验公式（希尔记法）:
C14H14N4O
化学文摘社编号:
133627-17-5
分子量:
254.29
UNSPSC Code:
41116107
NACRES:
NA.24

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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)

InChI key

HDVZWQWXAQRFKJ-UHFFFAOYSA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1460725

API family

nevirapine

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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General description

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.

Application

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.

Analysis Note

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

Other Notes

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.
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.

pictograms

Skull and crossbonesHealth hazard
GHS06,GHS08

signalword

Danger

Hazard Classifications

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

target_organs

Liver

存储类别

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

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

分析证书(COA)

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Nevirapine
USP42-NF37
United States Pharmacopeia/National Formulary, 32(3), 3101-3101 (2018)
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)
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)

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