Description

Lopinavir Ep Impurity K is a specified impurity and degradation product of the antiretroviral drug Lopinavir, used in the treatment of HIV. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control of the active pharmaceutical ingredient (API). It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Lopinavir-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Lopinavir impurities in API and finished dosage forms.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability and Forced Degradation Studies: Used to study the degradation pathways of Lopinavir under various stress conditions (e.g., heat, light, humidity, acid/base).
• Quality Control and Batch Release: Enables precise impurity profiling to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Facilitates process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Lopinavir Ep Impurity K
CAS No.	1623021-24-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lopinavir Impurity K; Lopinavir Related Compound K; Lopinavir EP Impurity K; Lopinavir Degradant K; (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 Impurity K; Lopinavir Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Lopinavir Ep Impurity K is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term stability, storage at 2-8°C is recommended. Handle the material under appropriate conditions to prevent contamination or degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.