Description

Landiolol Impurity 8 is a specified impurity and degradation product of the ultra-short-acting β-1 adrenergic receptor antagonist, Landiolol. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Landiolol hydrochloride active pharmaceutical ingredient (API) and its formulations. This impurity is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Landiolol Impurity 8 in Landiolol API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Landiolol batches comply with strict pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability studies.
• Regulatory Submissions: Provides essential data for regulatory filings (IND, NDA, ANDA, MAA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry & Optimization: Helps chemists identify and mitigate the source of this impurity during the synthesis and purification of Landiolol.

Basic Information

Item	Details
Product Name	Landiolol Impurity 8
CAS No.	144256-25-7
Molecular Formula	C₂₅H₃₈N₂O₄
Molecular Weight	430.58 g/mol
Synonyms	1-[4-[3-[(2-Hydroxy-3-[4-[(2-methoxyethoxy)methyl]phenoxy]propyl)amino]propoxy]phenyl]-2,2,2-trifluoroethanone; Landiolol Related Compound 8; Landiolol EP Impurity I; Landiolol Hydrochloride Impurity 8; UNII-9Q6JQ5Z2F4; Landiolol Degradant; (RS)-1-[4-[3-[[2-Hydroxy-3-[4-[(2-methoxyethoxy)methyl]phenoxy]propyl]amino]propoxy]phenyl]-2,2,2-trifluoroethanone
EINECS	Contact for details

Quality Control

Our Landiolol Impurity 8 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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