Description

Paroxetine-D6 Maleate is a deuterated internal standard of the antidepressant paroxetine, specifically designed for use in quantitative analytical techniques. This high-purity reference material is essential for ensuring the accuracy and reliability of mass spectrometry and chromatography-based analyses. It is primarily used by pharmaceutical research and development laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and bioanalytical studies.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in LC-MS/MS and GC-MS methods for the precise quantification of paroxetine in biological matrices (e.g., plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Drug Metabolism Studies: Used as a stable isotope-labeled tracer to investigate metabolic pathways and identify metabolites.
• Quality Control & Method Validation: Essential for validating analytical methods according to ICH, FDA, and EMA guidelines to ensure data integrity and regulatory compliance.
• Forensic Toxicology: Aids in the accurate determination of paroxetine levels in forensic investigations.
• Reference Standard for Pharmaceutical Testing: Used as a certified reference material for assay and impurity testing of active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Product Name	Paroxetine-D6 Maleate
CAS No.	1435728-64-5
Molecular Formula	C23H24D6FNO5
Molecular Weight	425.51 g/mol
Synonyms	(-)-trans-4-(4-Fluorophenyl)-3-{[3,4-(methylenedioxy)phenoxy]methyl}piperidine-d6 maleate; Paroxetine-d6 (maleate salt); 6,6-Dideuterio-paroxetine maleate; Paroxetine (phenyl-d6) maleate; SSRID6 maleate; BRL-29060-d6 maleate; Aropax-d6 maleate; Paxil-d6 maleate
EINECS	Contact for details

Quality Control

Our Paroxetine-D6 Maleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR, HPLC, and MS, to confirm identity, chemical purity, and isotopic enrichment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, residual solvents, and heavy metals. Our quality standards are designed to meet the rigorous demands of GLP and GMP environments for pharmaceutical research.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 1.0%

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