Description

Paroxetine Impurity 45 CAS NO 1396174-70-1 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient (API) Paroxetine. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Paroxetine API and related drug formulations.
• Impurity Profiling & Identification: Essential for characterizing and monitoring specific synthetic impurities or degradation products during Paroxetine manufacturing and stability studies.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Paroxetine API meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing definitive impurity identification data for health authorities like the FDA and EMA.
• Research & Development: Used in studies to understand the formation, fate, and toxicity of this specific impurity, supporting process improvement and risk assessment.

Basic Information

Product Name	Paroxetine Impurity 45
CAS No.	1396174-70-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paroxetine Related Compound 45; Paroxetine EP Impurity G; Paroxetine USP Impurity; Paroxetine Process Impurity; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine; Paroxetine Specified Impurity; Paroxetine Degradant
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Impurity 45 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with 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 (typically 15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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