Description

Bupropion Impurity 8 is a specified organic impurity associated with the active pharmaceutical ingredient (API) bupropion hydrochloride. This compound is critical for pharmaceutical research, development, and quality control, serving as a key reference standard for analytical method validation and impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bupropion Impurity 8 in bupropion hydrochloride API and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, validating, and transferring HPLC, UPLC, or LC-MS methods to monitor impurity levels according to ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to ensure API and drug product batches meet specified impurity limits and are safe for clinical use.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of bupropion, enabling process optimization to minimize its generation.

Basic Information

Product Name	Bupropion Impurity 8
CAS No.	376346-55-3
Molecular Formula	C13H18ClNO
Molecular Weight	239.74 g/mol
Synonyms	1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone; tert-Butylamino-3'-chloropropiophenone; Bupropion Related Compound A (in some contexts); Bupropion Chloro Impurity; 2-tert-Butylamino-3'-chloropropiophenone; 3'-Chloro-2-(tert-butylamino)propiophenone; α-(tert-Butylamino)-3-chloropropiophenone
EINECS	Contact for details

Quality Control

Every batch of Bupropion Impurity 8 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures the material is suitable for its intended use as a high-purity reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C Class 2 & 3 limits

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