Description

(3R,5Rs,6Rs)-6-(3-Chlorophenyl)-6-Hydroxy-5-Methyl-3-Thiomorpholine Carboxylic Acid is a critical process-related impurity and reference standard used in the development and quality control of the active pharmaceutical ingredient Bupropion. Its precise characterization is essential for pharmaceutical manufacturers to ensure product purity, safety, and regulatory compliance. This high-purity analytical standard is indispensable for researchers and quality control laboratories in the pharmaceutical industry focused on method validation and impurity profiling.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Bupropion-related impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Bupropion API and finished dosage forms.
• Essential for conducting stability studies and impurity profiling to meet ICH guidelines.
• Used in regulatory submissions (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Supports research and development of Bupropion synthesis pathways and process optimization.
• Employed in quality control laboratories for routine batch release testing of Bupropion hydrochloride.

Basic Information

Item	Details
Product Name	(3R,5Rs,6Rs)-6-(3-Chlorophenyl)-6-Hydroxy-5-Methyl-3-Thiomorpholine Carboxylic Acid (Bupropion Impurity)
CAS No.	1246812-57-6
Molecular Formula	C13H16ClNO3S
Molecular Weight	301.79 g/mol
Synonyms	Bupropion Impurity; Bupropion Related Compound; (3R,5R,6R)-6-(3-Chlorophenyl)-6-hydroxy-5-methylthiomorpholine-3-carboxylic acid; 6-(3-Chlorophenyl)-6-hydroxy-5-methyl-3-thiomorpholinecarboxylic acid; (3R,5R,6R)-6-(3-Chlorophenyl)-6-hydroxy-5-methyl-3-thiomorpholinecarboxylic acid; ZYJ-1302 Impurity; Amfebutamone Impurity
EINECS	Contact for details

Quality Control

Our (3R,5Rs,6Rs)-6-(3-Chlorophenyl)-6-Hydroxy-5-Methyl-3-Thiomorpholine Carboxylic Acid is manufactured under strict quality systems suitable for use as a reference standard. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and quality needs, ensuring traceability and compliance with current Good Manufacturing Practices (cGMP) where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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