Description

Amitriptyline n-Oxide is a key pharmaceutical intermediate and metabolite of the tricyclic antidepressant amitriptyline. This compound is essential for research and development in neuropharmacology, serving as a critical reference standard and a precursor in synthetic pathways. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and academic institutions focused on drug metabolism studies and analytical method development.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of amitriptyline and its metabolites in drug testing and bioanalytical studies.
• Metabolite Research: Critical for studying the pharmacokinetics, metabolic pathways, and biological activity of amitriptyline in preclinical and clinical research.
• Process Chemistry Intermediate: Employed in the synthesis and scale-up of amitriptyline and related tricyclic compounds within active pharmaceutical ingredient (API) manufacturing.
• Analytical Method Development: Serves as a key component in developing and validating HPLC, LC-MS, and GC-MS methods for impurity profiling and stability testing.
• Pharmacology Studies: Used in vitro and in vivo to investigate the pharmacological effects and safety profile of amitriptyline derivatives.
• Quality Control Laboratories: Acts as an impurity standard to monitor and control the quality of amitriptyline API batches according to pharmacopeial guidelines.

Basic Information

Product Name	Amitriptyline n-Oxide
CAS No.	4317-14-0
Molecular Formula	C20H23NO
Molecular Weight	293.41 g/mol
Synonyms	10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-δ5,γ-propylamine 5-Oxide; Amitriptyline N-Oxide; Amitriptyline Oxide; 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine N-oxide; NSC 113929; 5-(3-Dimethylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene 5-oxide
EINECS	Contact for details

Quality Control

Our Amitriptyline n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced chromatographic techniques to ensure it meets high-purity standards suitable for research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Single Maximum Unknown Impurity	≤0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Loss on Drying	≤0.5%

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