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Key Documents

Y0001498

Lopinavir

European Pharmacopoeia (EP) Reference Standard

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About This Item

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

biological source

synthetic

grade

pharmaceutical primary standard

agency

EP

API family

lopinavir

packaging

pkg of 170 mg

manufacturer/tradename

EDQM

storage condition

protect from light

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

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

InChI key

KJHKTHWMRKYKJE-SUGCFTRWSA-N

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.

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.

Application

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

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificados de análisis (COA)

Lot/Batch Number

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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, Biomedical Applications, 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)

Protocolos

This paper illustrates the setting up of a Lopinavir assay following European pharmacopoeia guidelines (10.2), and using a shorter column packed with smaller particles. The described assay saves valuable time and improves separation efficiency, which typically translates to better method performance.

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