Description

Protriptyline is a tricyclic antidepressant (TCA) compound, specifically a secondary amine derivative, known for its potent norepinephrine reuptake inhibition. This high-purity active pharmaceutical ingredient (API) is critical for pharmaceutical research, development, and manufacturing, ensuring reliable and consistent therapeutic outcomes. It is primarily utilized by pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) for the formulation of antidepressant medications and advanced neuropharmacological studies.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antidepressant medications.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Biochemical Research: Used in neuroscience and pharmacology research to study neurotransmitter reuptake mechanisms and receptor interactions.
• Formulation Development: Employed in pre-formulation and formulation studies for solid dosage forms like tablets and capsules.
• Impurity Profiling: Acts as a marker or precursor in the synthesis and identification of related compounds and potential degradants.
• Clinical Trial Material: Supplied as a key component for the production of drugs used in clinical research phases.

Basic Information

Product Name	Protriptyline
CAS No.	438-60-8
Molecular Formula	C19H21N
Molecular Weight	263.38 g/mol
Synonyms	Protriptyline Hydrochloride (common salt form); N-Methyl-5H-dibenzo[a,d]cycloheptene-5-propanamine; 5-(3-Methylaminopropyl)dibenzo[a,d][7]annulene; Vivactil (brand name); Concordin; Triptil; Maximed; Meridil; Tripress; Amimetil
EINECS	207-119-3

Quality Control

Our Protriptyline is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and strength, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) providing results for assay, related substances, residual solvents, and other critical parameters is supplied with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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