Description

Landiolol Impurity 7 is a specified impurity and degradation product of the ultra-short-acting β-1 adrenergic receptor blocker, Landiolol. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Landiolol hydrochloride active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Landiolol API.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Stability Studies: Used to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity profile data.
• Process Chemistry & Optimization: Helps in identifying and controlling the formation of this specific impurity during the synthesis and purification of Landiolol.
• Pharmacopoeial Testing: Potential use in testing to meet the specifications of pharmacopoeias such as USP, EP, or JP.

Basic Information

Item	Detail
Product Name	Landiolol Impurity 7
CAS No.	144256-26-8
Molecular Formula	C₂₅H₃₈N₄O₄
Molecular Weight	458.59 g/mol
Synonyms	ONO-1101 Impurity 7; Landiolol Related Compound 7; 4-[2-Hydroxy-3-[[2-[4-(3-methoxyphenyl)-1-piperazinyl]ethyl]amino]propoxy]benzenepropanenitrile; (RS)-4-[2-Hydroxy-3-[[2-[4-(3-methoxyphenyl)piperazin-1-yl]ethyl]amino]propoxy]hydrocinnamomitrile; Landiolol EP Impurity C; Landiolol Hydrochloride Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Landiolol Impurity 7 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to ensure traceability and support your regulatory needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.