Description

Landiolol Impurity K is a specified impurity and degradation product of the ultra-short-acting β-blocker Landiolol. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is essential for ensuring the purity, safety, and efficacy of Landiolol hydrochloride API and its finished drug products. This high-purity standard is primarily used by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Landiolol Impurity K in Landiolol hydrochloride active pharmaceutical ingredient (API).
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies & Forced Degradation: Used to identify and track degradation products formed during stability testing of Landiolol drug substance and products under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Enables precise impurity profiling and ensures batch-to-batch consistency and compliance with regulatory specifications for impurity limits.
• Pharmacopoeial Testing: Supports testing to meet the requirements of pharmacopoeial monographs (e.g., USP, EP, JP) for Landiolol and related formulations.
• Regulatory Submissions: Provides essential data and characterization support for regulatory filings (IND, NDA, ANDA, MAA) to demonstrate control of the impurity.
• Synthetic Chemistry Research: Used as an intermediate or marker to study and optimize the synthesis pathway of Landiolol, helping to minimize the formation of this impurity.

Basic Information

Product Name	Landiolol Impurity K
CAS No.	190601-22-0
Molecular Formula	C25H36N2O4
Molecular Weight	428.57 g/mol
Synonyms	ONO-1101 Impurity K; (2S)-2-{4-[(2S)-2-Hydroxy-3-{[2-(4-morpholinyl)ethyl]amino}propoxy]phenyl}acetamide; Landiolol Related Compound K; Landiolol EP Impurity K; Landiolol Hydrochloride Impurity K; Degradation Product of Landiolol
EINECS	Contact for details

Quality Control

Every batch of Landiolol Impurity K is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity (IR, NMR), purity (HPLC), and specified impurities. We support compliance with ICH guidelines and relevant pharmacopoeial standards.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.