Description

Bupropion Impurity 3 is a specified impurity associated with the active pharmaceutical ingredient Bupropion Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Bupropion-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bupropion Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with pharmacopoeial standards (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Facilitates studies on the degradation pathways and chemical stability of Bupropion.

Basic Information

Product Name	Bupropion Impurity 3
CAS No.	34509-36-9
Molecular Formula	C13H18ClNO
Molecular Weight	239.74 g/mol
Synonyms	2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one; (±)-2-(tert-Butylamino)-3'-chloropropiophenone; 1-Propanone, 2-[(1,1-dimethylethyl)amino]-1-(3-chlorophenyl)-; Bupropion Chloro Impurity; Bupropion Related Compound C; BW 323U Impurity
EINECS	Contact for details

Quality Control

Our Bupropion Impurity 3 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring compliance with ICH Q3A, Q3B, and relevant pharmacopoeial guidelines.

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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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