Description

(3S,5R,6R)-Bupropion Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) bupropion hydrochloride. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require precise impurity profiling and method validation. The availability of this well-characterized impurity supports robust analytical procedures and helps maintain stringent product quality standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification, qualification, and quantification of related substances in Bupropion HCl API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical system suitability component and for establishing detection limits in chromatographic methods for bupropion.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of bupropion.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the US FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the stereochemistry and metabolism of bupropion and to develop improved synthetic routes with lower impurity profiles.

Basic Information

Product Name	(3S,5R,6R)-Bupropion Impurity
CAS No.	2133460-43-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S,5R,6R)-Bupropion Related Compound; Bupropion Stereoisomer Impurity; (3S,5R,6R)-2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one; (3S,5R,6R)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone; A Bupropion Diastereomer; Bupropion EP Impurity; Bupropion USP Related Substance
EINECS	Contact for details

Quality Control

Every batch of (3S,5R,6R)-Bupropion Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The container should be kept securely sealed to protect against moisture and contamination.

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

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