PHR1927

Lopinavir

Pharmaceutical Secondary Standard; Certified Reference Material

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

Properties

• biological source: synthetic
• Quality Level: 300
• grade: certified reference material; pharmaceutical secondary standard
• Agency: BP; 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
• 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

Description

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, EP and BP primary standards, where they are available.

Other Notes

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.

Footnote

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.

Recommended products

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.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable