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Merck
CN

Y0001498

Lopinavir

European Pharmacopoeia (EP) Reference Standard

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About This Item

Empirical Formula (Hill Notation):
C37H48N4O5
CAS Number:
192725-17-0
Molecular Weight:
628.80
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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Product Name

Lopinavir, European Pharmacopoeia (EP) Reference Standard

API family

lopinavir

SMILES string

N4(CCCNC4=O)[C@@H](C(C)C)C(=O)N[C@H](C[C@H](O)[C@@H](NC(=O)COc3c(cccc3C)C)Cc2ccccc2)Cc1ccccc1

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

biological source

synthetic

grade

pharmaceutical primary standard

agency

EP

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

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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.

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.

Other Notes

Sales restrictions may apply.

Packaging

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

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificates of Analysis (COA)

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Lopinavir
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 3(F), 3111-3111 (2020)
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)
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, Biomedical Applications, 775(2), 225-230 (2002)
Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy
Lambert JS, et al.
HIV Medicine, 12(3), 166-173 (2011)
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)

Protocols

Lopinavir HPLC Assay Method

Lopinavir assay setup saves time and improves efficiency with shorter columns, meeting European pharmacopoeia guidelines.

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