Description

Brompheniramine-D6 Maleate is a stable isotope-labeled internal standard of the antihistamine brompheniramine, specifically designed for quantitative analytical applications. This high-purity compound is essential for ensuring accuracy and reliability in mass spectrometry-based methods, such as LC-MS/MS, by correcting for variations in sample preparation and instrument response. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology labs for method development, validation, and precise pharmacokinetic studies.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the accurate quantification of brompheniramine in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise measurement of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Forensic and Clinical Toxicology: Used in assays to detect and confirm the presence of brompheniramine in forensic investigations or therapeutic drug monitoring.
• Drug Metabolism and Disposition Studies: Facilitates research into the metabolic pathways and stability of brompheniramine.
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and assay development for drug substance and product quality control.

Basic Information

Product Name	Brompheniramine-D6 Maleate
CAS No.	1346606-73-2
Molecular Formula	C20H19D6BrN2O4
Molecular Weight	438.35 g/mol (for D6 labeled form)
Synonyms	Brompheniramine-d6 Maleate Salt; 2-[p-Bromo-α-[2-(dimethyl-d6-amino)ethyl]benzyl]pyridine Maleate; (+)-Brompheniramine-d6 Maleate; (3-(4-Bromophenyl)-N,N-dimethyl-3-pyrid-2-yl-propyl-d6-amine) Maleate; D6-Brompheniramine Maleate; Brompheniramine (dimethyl-d6) Maleate; Isotopically Labeled Brompheniramine Maleate
EINECS	Contact for details

Quality Control

Our Brompheniramine-D6 Maleate is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (atom % D), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We support compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. Keep the container tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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