Description

5-Chloro Bupropion-D9 Fumarate is a high-purity, deuterium-labeled internal standard critical for modern analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative analyses in pharmaceutical research and development. It is primarily used by analytical laboratories, CROs, and pharmaceutical companies engaged in method development, pharmacokinetic studies, and quality control for the active pharmaceutical ingredient bupropion and its metabolites.

Application

• Internal Standard for LC-MS/MS: Serves as a stable, non-interfering reference for the precise quantification of bupropion and 5-chloro bupropion in complex biological matrices like plasma, serum, and urine.
• Pharmaceutical R&D: Enables accurate pharmacokinetic (PK) and pharmacodynamic (PD) studies, supporting drug metabolism and bioavailability investigations for novel formulations.
• Bioanalytical Method Validation: A key component in developing and validating robust, regulatory-compliant analytical methods according to FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Used in the analysis of samples from clinical trials to monitor drug levels and ensure patient safety and study integrity.
• Forensic and Toxicology Testing: Facilitates the accurate detection and measurement of bupropion in forensic analyses and workplace drug testing programs.
• Quality Control & Stability Studies: Employed in pharmaceutical manufacturing to assess the purity, potency, and stability of drug substances and finished products over time.

Basic Information

Product Name	5-Chloro Bupropion-D9 Fumarate
CAS No.	1346606-75-4
Molecular Formula	C13H9D9ClNO • C4H4O4
Molecular Weight	Contact for details
Synonyms	(±)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone-D9 Fumarate; 5-Chloro Bupropion D9 Fumarate Salt; Bupropion Impurity D (Chloro Analog)-D9 Fumarate; 5-Chloro Bupropion-d9 Hemifumarate; 2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one-d9 Fumarate; 5-Chloro Wellbutrin-D9 Fumarate
EINECS	Contact for details

Quality Control

Every batch of 5-Chloro Bupropion-D9 Fumarate is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity, verified by advanced techniques including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, assay, and deuterium enrichment to meet the exacting standards of analytical and pharmaceutical laboratories.

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 under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms to structure
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 0.5%

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