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PHR1927

Lopinavir

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Lopinavir

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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
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biological source

synthetic

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

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

API family

lopinavir

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

protect from light

color

white to off-white

mp

255.2-260.6 °F (124—127°C)

solubility

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

application(s)

pharmaceutical

format

neat

shipped in

ambient

storage temp.

2-8°C

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

General description

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.

Analysis Note

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

Other Notes

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.
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.
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.

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Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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

Global Trade Item Number

SKUGTIN
PHR1927-1G04061835220953