Description

Loratadine Impurity 14 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antihistamine drug Loratadine by accurately identifying and quantifying related substances. It is an essential material for analytical chemists, quality assurance laboratories, and R&D departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Loratadine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate control strategies.
• Stability Studies: Used to track the formation of degradation products in Loratadine formulations under various stress conditions.
• Research & Development: Facilitates studies on the synthesis pathways, degradation routes, and metabolic profiles of Loratadine.

Basic Information

Product Name	Loratadine Impurity 14
CAS No.	31251-43-1
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Desloratadine Related Compound; Loratadine EP Impurity D; Loratadine USP Related Compound; Descarboethoxyloratadine; SCH 34117; 5H-Benzo[5,6]cyclohepta[1,2-b]pyridin-5-one, 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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.

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)	≤ 1.0%

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