Description

Lopinavir Ep Impurity Q is a high-purity reference standard used in the analytical development and quality control of the active pharmaceutical ingredient (API) Lopinavir. This compound is critical for ensuring the safety and efficacy of antiviral drug formulations by enabling the accurate identification and quantification of this specific process-related impurity. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance with pharmacopeial standards such as EP and USP.

Application

• Primary use as a pharmacopeial reference standard (EP/ICH) for Lopinavir impurity profiling.
• Method development and validation for HPLC and LC-MS analysis in quality control laboratories.
• Calibration and system suitability testing to ensure accuracy in impurity quantification.
• Research and development of impurity synthesis pathways and control strategies.
• Stability studies to monitor impurity levels in Lopinavir drug substances and products over time.
• Preparation of Certified Reference Materials (CRMs) for regulatory submissions and audits.

Basic Information

Product Name	Lopinavir Ep Impurity Q
CAS No.	667904-94-1
Molecular Formula	C37H48N4O5
Molecular Weight	628.81 g/mol
Synonyms	Lopinavir Impurity Q; Lopinavir Related Compound Q; (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 Impurity Q; Lopinavir EP Impurity Q
EINECS	Contact for details

Quality Control

Every batch of Lopinavir Ep Impurity Q is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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