Description

Hydroxybupropione is a key pharmaceutical intermediate and metabolite of the antidepressant bupropion. This compound matters for its critical role in the development and quality control of active pharmaceutical ingredients (APIs) targeting the central nervous system. It is primarily needed by pharmaceutical manufacturers and research institutions engaged in the synthesis of neuroactive drugs, analytical method development, and metabolic studies.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of bupropion hydrochloride and related therapeutic compounds.
• Reference Standard: Used as a high-purity analytical standard for HPLC, LC-MS, and GC-MS in pharmaceutical quality control laboratories.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism and activity of bupropion.
• Impurity Profiling: Serves as a known impurity marker to ensure the purity and safety of the final drug substance according to ICH guidelines.
• Research & Development: Utilized in medicinal chemistry for the design and development of new antidepressant and smoking cessation agents.
• Clinical Trial Materials: Supplied as a certified component for the manufacture of clinical trial batches.

Basic Information

Product Name	Hydroxybupropione
CAS No.	92264-81-8
Molecular Formula	C13H18ClNO
Molecular Weight	239.74 g/mol
Synonyms	2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-ol; (1R,2R)- and (1S,2S)-Hydroxybupropion; (±)-Hydroxybupropion; BW 306U; Hydroxybupropion Racemate; 306U; Bupropion Metabolite
EINECS	Contact for details

Quality Control

Our Hydroxybupropione is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling by validated methods such as HPLC and chromatography to ensure it meets high-purity standards suitable for pharmaceutical R&D and manufacturing. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified parameters.

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 minimize exposure to atmospheric moisture.

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%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤1.0%

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