Description

Loratadine Impurity 29 is a specified impurity used in the quality control and analytical profiling of the antihistamine drug Loratadine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference standard for method development, validation, and routine batch testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Used in routine impurity profiling to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, CMC sections) by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Loratadine Impurity 29
CAS No.	3964-78-1
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 Impurity; Loratadine Related Compound; 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-methylpiperidine; 1-Methyl-4-(8-chloro-5-oxo-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine
EINECS	Contact for details

Quality Control

Our Loratadine Impurity 29 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical impurity analysis. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, ensuring traceability and compliance with ICH Q3A/B and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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