Description

Loratadine-D5 (Ethyl-D5) is a stable isotope-labeled internal standard, specifically a deuterated analog of the widely used antihistamine Loratadine. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as Liquid Chromatography-Mass Spectrometry (LC-MS/MS). It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities for pharmacokinetic studies, drug metabolism research, and high-precision quality control of Loratadine-based formulations.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise quantification of Loratadine and its metabolites in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Drug Metabolism and Disposition Research: Used to study metabolic pathways and identify metabolites without interference from endogenous compounds.
• Method Development and Validation: A key component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control & Assurance: Employed in the pharmaceutical industry for the accurate assay of Loratadine in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Forensic and Toxicology Analysis: Supports accurate measurement in forensic investigations and toxicological screenings.

Basic Information

Product Name	Loratadine-D5 (Ethyl-D5)
CAS No.	1398065-63-8
Molecular Formula	C22H18ClD5N2O2
Molecular Weight	~ 387.90 g/mol
Synonyms	Ethyl-d5-Loratadine; Loratadine (ethyl-d5); 8-Chloro-6,11-dihydro-11-(1-[(ethoxy-d5)carbonyl]-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Deuterated Loratadine; Loratadine-d5 Internal Standard; [D5]-Loratadine; Claritin-D5 (Ethyl-D5)
EINECS	Contact for details

Quality Control

Our Loratadine-D5 (Ethyl-D5) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high chemical and isotopic purity, critical for its performance as an internal standard. We provide comprehensive Certificates of Analysis (COA) detailing specifications for identity, assay, isotopic enrichment, and purity by HPLC. Our quality commitment aligns with the standards expected for pharmaceutical reference materials and analytical reagents.

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); ensure the container is sealed after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (Mass Spectrometry)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 99.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 0.5%

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