Description

3-Hydroxy Loratadine is a key active pharmaceutical intermediate (API) and metabolite of the widely used antihistamine, Loratadine. This compound is critical for the development and quality control of advanced pharmaceutical formulations targeting allergic conditions. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the synthesis of new drugs, analytical method development, and reference standard production.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of next-generation antihistamine drugs and related pharmaceutical compounds.
• Reference Standard: Used as a certified reference material (CRM) for analytical method validation, quality control, and regulatory compliance in pharmaceutical laboratories.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to study the metabolism, efficacy, and safety profile of Loratadine.
• Analytical Chemistry: Serves as a high-purity standard for HPLC, LC-MS, and other chromatographic techniques in impurity profiling and assay development.
• Active Pharmaceutical Ingredient (API) Manufacturing: Incorporated into the production of finished dosage forms for allergy and inflammation medications.
• Biomedical Research: Employed in preclinical and clinical research to investigate histamine H1-receptor antagonist mechanisms and therapeutic effects.

Basic Information

Item	Detail
Product Name	3-Hydroxy Loratadine
CAS No.	183483-15-0
Molecular Formula	C22H23ClN2O3
Molecular Weight	398.88 g/mol
Synonyms	Desloratadine Impurity C; Loratadine Metabolite III; 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-3-ol; 3-OH-Loratadine; Nor-Loratadine Carbinol; SCH 34117; 183483-15-0
EINECS	Contact for details

Quality Control

Our 3-Hydroxy Loratadine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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