Description

Amitriptyline Hydrochloride is a tricyclic antidepressant (TCA) compound of significant pharmaceutical importance. Its primary value lies in its potent action as a serotonin-norepinephrine reuptake inhibitor, making it a critical active pharmaceutical ingredient (API) for the formulation of antidepressant and neuropathic pain management medications. This high-purity compound is essential for manufacturers in the global pharmaceutical industry, particularly those developing and producing generic and branded antidepressant tablets, capsules, and other dosage forms.

Application

• Pharmaceutical API: Primary use as the active ingredient in antidepressant medications.
• Neuropathic Pain Treatment: Formulation component for drugs targeting chronic pain conditions like fibromyalgia and diabetic neuropathy.
• Generic Drug Manufacturing: Sourcing for cost-effective production of generic amitriptyline hydrochloride tablets and capsules.
• Clinical Research: Reference standard and raw material for pharmacological and toxicological studies.
• Veterinary Medicine: Used in certain veterinary applications for behavioral and pain management in animals.
• Analytical Standard: Serves as a high-purity standard for quality control laboratories in pharmaceutical analysis.

Basic Information

Product Name	Amitriptyline Hydrochloride
CAS No.	549-18-8
Molecular Formula	C20H23N·HCl
Molecular Weight	313.87 g/mol
Synonyms	Amitriptyline HCl; 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride; Elavil Hydrochloride; Laroxyl; Saroten; Tryptizol; Amitid; Amitril; Domical; Lentizol
EINECS	208-964-5

Quality Control

Our Amitriptyline Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent pharmacopeial standards, including USP, EP, and BP monographs. Key parameters such as identity, assay, related substances, residual solvents, and microbiological purity are verified. A detailed Certificate of Analysis (COA) is provided with every shipment to guarantee traceability and compliance.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere packing.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.1%; Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets EP/USP criteria for non-sterile substances

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