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Key Documents

PHR1927

Supelco

Lopinavir

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Lopinavir

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About This Item

Fórmula empírica (Notação de Hill):
C37H48N4O5
Número CAS:
Peso molecular:
628.80
Código UNSPSC:
41116107
NACRES:
NA.24

fonte biológica

synthetic

Nível de qualidade

grau

certified reference material
pharmaceutical secondary standard

Agency

BP
EP
USP
traceable to Ph. Eur. Y0001498
traceable to USP 1370101

família API

lopinavir

forma

powder

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 1 g

condição de armazenamento

protect from light

cor

white to off-white

pf

255.2-260.6 °F (124—127°C)

solubilidade

chloroform: soluble
isopropanol: soluble
methanol: freely soluble
methylene chloride: freely soluble
water: practically insoluble

aplicação(ões)

pharmaceutical

formato

neat

Condições de expedição

ambient

temperatura de armazenamento

2-8°C

InChI

1S/C37H48N4O5/c1-25(2)34(41-20-12-19-38-37(41)45)36(44)39-30(21-28-15-7-5-8-16-28)23-32(42)31(22-29-17-9-6-10-18-29)40-33(43)24-46-35-26(3)13-11-14-27(35)4/h5-11,13-18,25,30-32,34,42H,12,19-24H2,1-4H3,(H,38,45)(H,39,44)(H,40,43)/t30-,31-,32-,34-/m0/s1

chave InChI

KJHKTHWMRKYKJE-SUGCFTRWSA-N

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Descrição geral

Lopinavir is an antiretroviral agent and a protease inhibitor indicated for the management of human immunodeficiency virus (HIV) infection. It is a key component of Kaletra, the co-formulation of lopinavir and ritonavir.
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.

Aplicação

Lopinavir may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and clinical plasma samples by chromatography techniques.
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.

Nota de análise

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

Outras notas

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 de rodapé

To see an example of a Certificate of Analysis for this material enter LRAB1665 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Produtos recomendados

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.

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Certificados de análise (COA)

Lot/Batch Number

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Validation and application of a high-performance liquid chromatography-tandem mass spectrometric method for simultaneous quantification of lopinavir and ritonavir in human plasma using semi-automated 96-well liquid-liquid extraction
Wang PG, et al.
Journal of Chromatography A, 1130(2), 302-307 (2006)
Simultaneous determination of indinavir, ritonavir and lopinavir (ABT 378) in human plasma by high-performance liquid chromatography
Ray J, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 775(2), 225-230 (2002)
Determination of 19 antiretroviral agents in pharmaceuticals or suspected products with two methods using high-performance liquid chromatography
Rebiere H, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 850(1-2), 376-383 (2007)
Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy
Lambert JS, et al.
HIV Medicine, 12(3), 166-173 (2011)

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