Description

4-Hydroxymethyl Loratadine is a key pharmaceutical intermediate and an active metabolite of the widely used antihistamine, Loratadine. This compound is critical for ensuring the efficacy and quality of final drug formulations in the pharmaceutical manufacturing process. It is primarily required by pharmaceutical companies and research institutions engaged in the development and production of advanced antihistamine medications and related analytical standards.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: A crucial building block in the synthesis of Loratadine and its derivative formulations.
• Pharmaceutical Reference Standard: Used in analytical laboratories for quality control, method development, and validation in drug testing.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand drug metabolism and activity.
• Process Development: Serves as a key intermediate in scaling up and optimizing manufacturing processes for antihistamine drugs.
• Impurity Profiling: Employed as a certified standard to identify and quantify related substances in final drug products.

Basic Information

Product Name	4-Hydroxymethyl Loratadine
CAS No.	609806-40-8
Molecular Formula	C23H25ClN2O3
Molecular Weight	412.91 g/mol
Synonyms	Desloratadine Impurity F; Loratadine Hydroxymethyl Metabolite; 4-(Hydroxymethyl)loratadine; 8-Chloro-6,11-dihydro-11-(1-hydroxy-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; 4-Hydroxymethyl Descarbethoxy Loratadine; 4-Hydroxymethyl DLRT
EINECS	Contact for details

Quality Control

Our 4-Hydroxymethyl Loratadine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure high purity and consistency. Certificates of Analysis (COA) detailing all specifications are provided and can be tailored to meet specific pharmacopeial standards (e.g., USP, EP) or client requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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