Description

Bupropion Hydrochloride Related Compound B is a high-purity chemical reference standard, essential for the accurate analysis and quality control of the active pharmaceutical ingredient bupropion hydrochloride. This compound serves as a critical impurity marker, enabling pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily required by the pharmaceutical industry for research, method development, and routine quality testing in accordance with ICH guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in bupropion hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, validating, and transferring HPLC, UPLC, or GC analytical methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in bupropion hydrochloride under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the US FDA and EMA.
• Pharmacopoeial Testing: Used to verify compliance with impurity limits specified in pharmacopoeial monographs such as USP or EP for bupropion hydrochloride.
• Contract Research & Manufacturing (CRO/CMO): Essential for third-party testing and manufacturing services to ensure batch-to-batch consistency and quality.

Basic Information

Product Name	Bupropion Hydrochloride Related Compound B
CAS No.	1049974-35-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride; Bupropion Impurity B; Bupropion Related Substance B; Bupropion HCl Related Compound B; Amfebutamone Related Compound B; (±)-2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride
EINECS	Contact for details

Quality Control

Our Bupropion Hydrochloride Related Compound B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity assessment by chromatographic techniques (HPLC). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 in a desiccated environment to maintain stability and purity. The container should be stored in a well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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