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PHR1762

Supelco

Nevirapine Related Compound C

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
5,11-DIHYDRO-6H-11-PROPYL-4 -METHYL-DIPYRIDO [3,2-b:2’,3’-e][1,4] DIAZEPIN-6-ONE, 5,11-Dihydro-4-methyl-11-propyl-6H-dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one
Empirical Formula (Hill Notation):
C15H16N4O
CAS Number:
Molecular Weight:
268.31
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

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

pharmacopeia traceability

traceable to USP 1460747

storage temp.

2-30°C

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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 is a member of the dipyridodiazepinone chemical class of compounds and is found to be the first antiretroviral agent, widely used for the treatment of adults and adolescents affected with human immunodeficiency viruses (HIV). Its mode of action involves slowing down damage to the immune system and suppresses the occurrence of AIDS-defining illnesses, via preventing HIV from replicating within cells by binding near reverse transcriptase′s active site and inhibiting polymerase activity

Application

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.
Nevirapine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical samples using reversed-phase high-performance liquid chromatography technique.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP 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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA8555 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

13 - Non Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

A simple and rapid RP-HPLC method for the estimation of nevirapine in bulk and pharmaceutical dosage forms
Mohanraj P, et al.
Journal of Chemistry, 5(S2), 1081-1086 (2008)
Identification, Isolation and Characterization of Unknown Acid Degradation Product of Nevirapine
Pottabathini V, et al.
American Journal of Analytical Chemistry, 7(09), 663-663 (2016)
Development of a liposomal nanodelivery system for nevirapine
Ramana NL, et al.
Journal of Biomedical Science, 17(1), 57-57 (2010)

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