Description

Lopinavir Metabolite m-3/m-4 is a key reference standard and impurity used in the development and quality control of the antiretroviral drug Lopinavir. This compound is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling the accurate identification and quantification of metabolic byproducts. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in antiviral drug research, production, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods in QC/QA labs.
• Impurity Profiling & Control: Used to identify, monitor, and quantify specific metabolic impurities in active pharmaceutical ingredient (API) and finished drug product batches.
• Metabolic Pathway Studies: A vital tool in preclinical and clinical research to understand the biotransformation and pharmacokinetics of Lopinavir.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Method Development & Validation: Employed in the development and validation of stability-indicating analytical methods such as HPLC and LC-MS.
• Stability Testing: Used as a marker in forced degradation studies to assess drug product stability under various stress conditions.

Basic Information

Product Name	Lopinavir Metabolite m-3/m-4
CAS No.	357275-54-8
Molecular Formula	C37H48N4O5
Molecular Weight	628.80 g/mol
Synonyms	Lopinavir Metabolite M3/M4; Lopinavir Metabolite m3/m4; Lopinavir Metabolite m-3; Lopinavir Metabolite m-4; Lopinavir Related Compound m-3/m-4; (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; LPV Metabolite m-3/m-4
EINECS	Contact for details

Quality Control

Our Lopinavir Metabolite m-3/m-4 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting the exact purity, chromatographic profile, and results of all specified tests.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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