Description

Loratadine-D4 Epoxide n-Oxide is a high-purity, deuterium-labeled derivative of a key loratadine metabolite. This compound is essential for use as a certified reference standard in advanced analytical chemistry, providing the isotopic purity and structural fidelity required for precise quantification. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and regulatory compliance in bioanalytical studies.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantification of loratadine and its metabolites in biological matrices.
• Bioanalytical Method Development: Used in LC-MS/MS and HPLC method development and validation to ensure accuracy, precision, and specificity.
• Pharmacokinetic & Metabolite Studies: Enables precise tracking and quantification of drug metabolism pathways in preclinical and clinical research.
• Doping Control & Forensic Analysis: Applied in sensitive assays for detecting pharmaceutical substances in sports anti-doping and forensic toxicology.
• Quality Control & Assurance: Acts as an internal standard in quality control laboratories to verify assay accuracy and system suitability for pharmaceutical batch release.
• Regulatory Submissions: Supports data packages for regulatory filings (e.g., FDA, EMA) requiring validated analytical methods with deuterated internal standards.

Basic Information

Product Name	Loratadine-D4 Epoxide n-Oxide
CAS No.	1794754-14-5
Molecular Formula	C22H19D4ClN2O3
Molecular Weight	398.90 g/mol (for C22H19D4ClN2O3)
Synonyms	Loratadine-d4 Epoxide N-Oxide; Deuterated Loratadine Epoxide N-Oxide; Loratadine D4 Epoxide N-Oxide; [²H₄]-Loratadine Epoxide N-Oxide; 8-Chloro-6,11-dihydro-11-(1-[(2H₄)methyl-4-piperidinylidene])-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Epoxide N-Oxide; Loratadine (D4) Epoxide N-Oxide; Loratadine-d4 Metabolite Standard
EINECS	Contact for details

Quality Control

Every batch of Loratadine-D4 Epoxide n-Oxide is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and isotopic enrichment testing using advanced techniques including NMR, HPLC, and mass spectrometry to ensure compliance with the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity, isotopic purity, and related substances is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
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.