Description

Loratadine Impurity 31 is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities during the manufacture of the antihistamine drug, Loratadine. It is an essential material for analytical laboratories and pharmaceutical companies committed to ensuring product safety, efficacy, and regulatory compliance. The compound is supplied under strict quality protocols to meet the exacting standards of the global pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Serves 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 and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to ensure Loratadine products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Loratadine.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research and Development: Utilized in synthetic chemistry research to study the formation and fate of this impurity during the Loratadine manufacturing process.

Basic Information

Product Name	Loratadine Impurity 31
CAS No.	609806-38-4
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Loratadine Related Compound 31; 8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Desloratadine Impurity; 8-Chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine-5-one; Loratadine EP Impurity G; Loratadine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 31 is manufactured and analyzed under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect the material from moisture and contamination.

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 impurity ≤ 1.0%
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.