Description

Lopinavir Metabolite m-1 is a key pharmacologically relevant metabolite of the antiretroviral drug Lopinavir, identified by CAS number 192725-39-6. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of analytical reference standards. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in antiviral drug development, bioanalytical method validation, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Lopinavir and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and bioavailability of Lopinavir in preclinical and clinical research.
• Impurity Profiling and Control: Essential for identifying, characterizing, and quantifying process-related impurities and degradation products in active pharmaceutical ingredient (API) batches to meet ICH guidelines.
• Bioanalytical Method Development: A critical component for developing and validating robust HPLC, LC-MS, or GC-MS methods for therapeutic drug monitoring.
• Toxicology and Safety Assessment: Employed in studies to understand the safety profile and potential toxic effects of Lopinavir metabolites.
• Academic and Institutional Research: Used in virology and medicinal chemistry research to study structure-activity relationships and resistance mechanisms of HIV protease inhibitors.

Basic Information

Product Name	Lopinavir Metabolite m-1
CAS No.	192725-39-6
Molecular Formula	C₃₇H₄₈N₄O₅
Molecular Weight	628.81 g/mol
Synonyms	Lopinavir Metabolite M1; Lopinavir Hydroxy Metabolite; (2S)-N-[(2S,4S,5S)-5-[[2-(2,6-Dimethylphenoxy)acetyl]amino]-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxo-1,3-diazinan-1-yl)butanamide; ABT-378 Metabolite m-1; LPV Metabolite m-1
EINECS	Contact for details

Quality Control

Our Lopinavir Metabolite m-1 is manufactured under strict quality management systems. Every batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical research. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.