Description

4,8-Dichloro-5,6-Dihydro-11H-Benzo[5,6]Cyclohepta[1,2-β]Pyridin-11-One (Loratadine Impurity) is a critical pharmaceutical reference standard and process impurity used in the development and quality control of the widely used antihistamine, Loratadine. Its availability is essential for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. This high-purity compound is primarily targeted at the pharmaceutical R&D, quality assurance (QA), and quality control (QC) sectors for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of this specific impurity in Loratadine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), and other analytical techniques to develop and validate impurity testing methods.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Process Chemistry Research: Employed in studies to understand the formation, fate, and purge of this impurity during Loratadine synthesis, aiding in process optimization.
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., with FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Stability Studies: Used as a marker to assess the degradation profile and long-term stability of Loratadine under various storage conditions.

Basic Information

Product Name	4,8-Dichloro-5,6-Dihydro-11H-Benzo[5,6]Cyclohepta[1,2-β]Pyridin-11-One (Loratadine Impurity)
CAS No.	133330-60-6
Molecular Formula	C19H15Cl2NO
Molecular Weight	344.24 g/mol
Synonyms	Loratadine Impurity; Loratadine Related Compound; 4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one; 11H-Benzo[5,6]cyclohepta[1,2-b]pyridin-11-one, 4,8-dichloro-5,6-dihydro-; Loratadine EP Impurity; Loratadine USP Impurity
EINECS	Contact for details

Quality Control

Our 4,8-Dichloro-5,6-Dihydro-11H-Benzo[5,6]Cyclohepta[1,2-β]Pyridin-11-One is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical impurity standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary reference standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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