Description

Paroxetine HCl Hemihydrate Impurity C HCl is a high-purity chemical reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity in the synthesis and purification of the active pharmaceutical ingredient (API) Paroxetine Hydrochloride Hemihydrate, enabling precise monitoring and control. It is essential for analytical chemists, quality assurance professionals, and research scientists in the pharmaceutical industry who require reliable reference materials for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference standard in HPLC, UPLC, and LC-MS methods to identify, quantify, and control this specific impurity in Paroxetine HCl Hemihydrate API batches.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating assay methods as per ICH Q2(R1) guidelines for Paroxetine formulations.
• Quality Control and Release Testing: Employed in in-house QC laboratories of API manufacturers and finished dosage form producers to ensure product purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions and Compliance: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Research and Development: Facilitates process chemistry research aimed at optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Paroxetine HCl Hemihydrate Impurity C HCl
CAS No.	1395408-54-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paroxetine Related Compound C; Paroxetine Impurity C; (-)-trans-4-(4'-Fluorophenyl)-3-[[3',4'-(methylenedioxy)phenoxy]methyl]piperidine Hydrochloride Hemihydrate Impurity; Paroxetine Hydrochloride Hemihydrate Impurity C; UNII-9P3E4C6U3S (base); Paroxetine HCl Impurity C (HCl salt)
EINECS	Contact for details

Quality Control

Every batch of Paroxetine HCl Hemihydrate Impurity C HCl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, LC-MS) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and purity. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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