Description

Loratadine Epoxide is a key pharmaceutical intermediate and impurity reference standard, primarily associated with the synthesis and quality control of the widely used antihistamine, Loratadine. Its precise chemical structure makes it critical for analytical method development, stability studies, and ensuring the purity and safety of the final active pharmaceutical ingredient (API). This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and quality control laboratories engaged in the development, production, and regulatory compliance of antihistamine medications.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Loratadine API.
• Analytical Reference Standard: Used as a certified impurity standard for HPLC, GC, and other chromatographic methods to quantify related substances in Loratadine drug substance and finished products.
• Stability Testing: Employed in forced degradation studies to identify and characterize potential degradation products of Loratadine.
• Method Development and Validation: Serves as a critical component for developing and validating analytical procedures in compliance with ICH guidelines.
• Pharmacological Research: Used in metabolic and pharmacokinetic studies to understand the biotransformation pathways of Loratadine.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch release testing to ensure drug purity and meet pharmacopoeial specifications (e.g., USP, EP).

Basic Information

Product Name	Loratadine Epoxide
CAS No.	1189694-51-6
Molecular Formula	C22H23ClN2O3
Molecular Weight	398.88 g/mol
Synonyms	Loratadine Epoxide; Loratadine Oxide; 8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 10,11-epoxide; 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-methylpiperidine 10,11-epoxide; Loratadine Impurity F (EP); Loratadine Related Compound F (USP); Loratadine 10,11-Epoxide
EINECS	Contact for details

Quality Control

Our Loratadine Epoxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of specified impurities, to ensure it meets high-purity standards suitable for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with in-house specifications aligned with pharmacopoeial expectations.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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