Description

Lopinavir Ep Impurity P is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Lopinavir. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the identification and quantification of Lopinavir Ep Impurity P in API batches.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Lopinavir drug substance and finished products.
• Essential for conducting impurity profiling studies to support regulatory filings (e.g., ANDA, NDA) and stability testing.
• Used in quality control (QC) laboratories for routine batch release testing of Lopinavir to ensure pharmacopeial compliance (USP, EP).
• Valuable material for research and development into the degradation pathways and stability of Lopinavir.
• Serves as a system suitability standard in chromatographic analysis to ensure the performance of the testing equipment.

Basic Information

Product Name	Lopinavir Ep Impurity P
CAS No.	1217628-64-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lopinavir Related Compound P; Lopinavir Impurity P; Lopinavir EP Impurity P; Lopinavir European Pharmacopoeia Impurity P; (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 (IUPAC); LPV Impurity P; Lopinavir Specified Impurity.
EINECS	Contact for details

Quality Control

Every batch of Lopinavir Ep Impurity P is manufactured and controlled to meet the highest standards for pharmaceutical reference materials. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality system is designed to support compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity during use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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