Description

Paroxetine Related Compound C (15 Mg) ((+)-trans-Paroxetine Hydrochloride) is a high-purity analytical reference standard used for pharmaceutical quality control and research. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) paroxetine, a widely prescribed selective serotonin reuptake inhibitor (SSRI). It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling in compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific process-related impurities or degradation products in paroxetine API and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, primarily HPLC and UPLC, ensuring accurate and reliable analytical results.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels and confirm product specifications are met.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive data on impurity structures and concentrations required in drug master files (DMFs).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of paroxetine to understand its degradation pathways and shelf-life.
• Research and Development (R&D): Used in academic and industrial R&D for metabolic studies, pharmacokinetic research, and the synthesis of novel paroxetine derivatives.

Basic Information

Product Name	Paroxetine Related Compound C (15 Mg) ((+)-trans-Paroxetine Hydrochloride)
CAS No.	130855-30-0
Molecular Formula	C19H21FNO4·HCl
Molecular Weight	381.83 g/mol (as hydrochloride salt)
Synonyms	(+)-trans-Paroxetine Hydrochloride; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine Hydrochloride; Paroxetine Impurity C; Paroxetine Related Substance C; Paroxetine EP Impurity C; Paroxetine USP Related Compound C; BRL 29060A; FG 7051 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Related Compound C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with USP, EP, and ICH Q3A/B guidelines.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to high humidity and temperature fluctuations.

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% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Heavy Metals	≤ 20 ppm

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