Description

Bupropion Hydrobromide is the hydrobromide salt form of the active pharmaceutical ingredient bupropion, a compound of significant therapeutic importance. This high-purity intermediate is critical for ensuring the efficacy, stability, and consistent quality of the final drug product. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of antidepressant and smoking cessation medications.

Application

• Pharmaceutical Active Ingredient (API) Synthesis: Primary use as the key intermediate in the manufacture of bupropion hydrochloride, the final active pharmaceutical ingredient.
• Antidepressant Formulations: Essential for the production of medications used to treat major depressive disorder and seasonal affective disorder.
• Smoking Cessation Therapies: A critical component in the synthesis of drugs designed to aid in nicotine withdrawal and smoking cessation.
• Reference Standard & Calibration: Serves as a high-purity standard for analytical method development, validation, and quality control testing in regulatory and R&D laboratories.
• Clinical Research Materials: Used in the preparation of investigational new drugs (INDs) for preclinical and clinical trial studies.
• Controlled-Release Drug Delivery Systems: Employed in the development of extended-release formulations to provide sustained therapeutic effects.

Basic Information

Product Name	Bupropion Hydrobromide
CAS No.	905818-69-1
Molecular Formula	C13H19ClN2O • HBr
Molecular Weight	344.67 g/mol
Synonyms	(±)-2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide; Amfebutamone Hydrobromide; BW 323U Hydrobromide; Zyban Impurity Hydrobromide; Bupropion HBr; 1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrobromide
EINECS	Contact for details

Quality Control

Our Bupropion Hydrobromide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles, suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing results from tests such as HPLC assay, related substances, residual solvents, and identification 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, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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