Description

Bupropion Impurity 15 is a specified impurity and degradation product associated with the active pharmaceutical ingredient Bupropion Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers, contract research organizations (CROs), and regulatory bodies focused on ensuring the purity, safety, and efficacy of bupropion-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bupropion Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, validating, and verifying chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., USP, ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Bupropion Impurity 15
CAS No.	92821-91-5
Molecular Formula	C13H18ClNO
Molecular Weight	239.74 g/mol
Synonyms	1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone; tert-Butylamino-3'-chloropropiophenone; Bupropion Related Compound C; Bupropion Chloro Impurity; Bupropion EP Impurity C; Bupropion USP Related Compound C; Amfebutamone Impurity C
EINECS	Contact for details

Quality Control

Our Bupropion Impurity 15 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide full traceability and a detailed Certificate of Analysis (COA) that includes batch-specific data, ensuring compliance with current Good Manufacturing Practice (cGMP) and ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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