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Principaux documents

PHR1927

Supelco

Lopinavir

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Lopinavir

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About This Item

Formule empirique (notation de Hill):
C37H48N4O5
Numéro CAS:
Poids moléculaire :
628.80
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Source biologique

synthetic

Niveau de qualité

Qualité

certified reference material
pharmaceutical secondary standard

Agence

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

Famille d'API

lopinavir

Forme

powder

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 g

Conditions de stockage

protect from light

Couleur

white to off-white

Pf

255.2-260.6 °F (124—127°C)

Solubilité

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

Application(s)

pharmaceutical

Format

neat

Conditions d'expédition

ambient

Température de stockage

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

Clé InChI

KJHKTHWMRKYKJE-SUGCFTRWSA-N

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Description générale

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.

Application

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Produits recommandés

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.

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

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)
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)
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)
Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy
Lambert JS, et al.
HIV Medicine, 12(3), 166-173 (2011)

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