Description

Amitriptyline n-Oxide Hydrochloride is a key pharmaceutical intermediate and metabolite of the tricyclic antidepressant amitriptyline. This compound is of significant value in research and development for studying drug metabolism, pharmacokinetics, and for the synthesis of analytical reference standards. It is primarily required by pharmaceutical R&D laboratories, analytical service providers, and manufacturers of high-purity fine chemicals for use in method development, impurity profiling, and metabolic studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of amitriptyline and its metabolites in drug substance and finished product analysis.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, bioavailability, and excretion profiles of amitriptyline.
• Impurity Standard: Serves as a specified impurity standard in the quality control (QC) and stability testing of amitriptyline active pharmaceutical ingredients (APIs) to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Biochemical Research: Employed in neuroscience and pharmacological research to study the effects and mechanisms of amitriptyline metabolites.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, LC-MS) for the separation and detection of amitriptyline and its related substances.
• Fine Chemical Synthesis: Used as a building block or precursor in the synthesis of more complex chemical entities for research purposes.

Basic Information

Product Name	Amitriptyline n-Oxide Hydrochloride
CAS No.	4290-60-2
Molecular Formula	C₂₀H₂₄ClNO₂
Molecular Weight	345.86 g/mol
Synonyms	5-(3-Dimethylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene N-Oxide Hydrochloride; Amitriptyline N-Oxide HCl; 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-δ⁵⁺⁶-propylamine N-Oxide Hydrochloride; Amitriptyline Impurity F (EP); Amitriptyline Related Compound F (USP); NSC 113193; Amitriptylinoxide Hydrochloride
EINECS	Contact for details

Quality Control

Our Amitriptyline n-Oxide Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via techniques such as HPLC, IR, and NMR, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.