Description

Loratadine Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Loratadine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The product is supplied with comprehensive analytical data to support your research and compliance needs.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Loratadine API.
• Essential for pharmaceutical research and development (R&D) during process optimization and stability studies.
• Critical component in analytical method development and validation (HPLC, LC-MS) for impurity profiling.
• Used for quality control (QC) and quality assurance (QA) in pharmaceutical manufacturing to meet ICH guidelines.
• Serves as a calibration standard in regulatory submissions and pharmacopeial testing (USP, EP).
• Valuable for academic and institutional research studying the degradation pathways and metabolism of Loratadine.

Basic Information

Product Name	Loratadine Impurity 14
CAS No.	169253-13-8
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Loratadine Related Compound; 8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Desloratadine Impurity; Loratadine EP Impurity; Loratadine USP Impurity; 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 tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards. We support regulatory filings with full documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent absorption of atmospheric moisture, which could affect stability and purity.

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 ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.