Description

(3S,5S,6S)-Bupropion Impurity is a high-purity stereoisomeric impurity associated with the synthesis of the antidepressant drug Bupropion. This compound is critical for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, R&D facilities, and quality assurance departments within the pharmaceutical and fine chemical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of stereoisomeric impurities in Bupropion API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to monitor process-related impurities.
• Quality Control & Assurance: A critical component in the impurity profile testing of Bupropion batches to ensure compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific stereoisomer during API manufacturing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed as a marker to assess the degradation pathways and shelf-life stability of Bupropion formulations under various storage conditions.

Basic Information

Product Name	(3S,5S,6S)-Bupropion Impurity
CAS No.	2133460-42-9
Molecular Formula	C13H18ClNO
Molecular Weight	239.74 g/mol
Synonyms	(3S,5S,6S)-2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one; (3S,5S,6S)-Bupropion Related Compound; (3S,5S,6S)-BW 323U Impurity; Stereoisomer of Bupropion; (3S,5S,6S)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone; (3S,5S,6S)-Chloropropiophenone derivative; Bupropion Stereoisomeric Impurity C
EINECS	Contact for details

Quality Control

Every batch of (3S,5S,6S)-Bupropion Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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.