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Merck
CN

PHR1760

Supelco

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代码:
41116107
NACRES:
NA.24

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等级

certified reference material
pharmaceutical secondary standard

质量水平

300

Agency

traceable to USP 1460725

API类

nevirapine

CofA

current certificate can be downloaded

包装

pkg of 50 mg

技术

HPLC: suitable
gas chromatography (GC): suitable

应用

pharmaceutical (small molecule)

包装形式

neat

储存温度

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)

InChI key

HDVZWQWXAQRFKJ-UHFFFAOYSA-N

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一般描述

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.

应用

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.

分析说明

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

其他说明

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.

象形图

Skull and crossbonesHealth hazard
GHS06,GHS08

警示用语：

Danger

危险声明

H301,H317,H373

危险分类

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

靶器官

Liver

储存分类代码

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

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable

分析证书(COA)

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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)
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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