Description

Paroxetine HCl Hemihydrate Impurity B HCl is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Paroxetine HCl Hemihydrate by serving as a known benchmark for impurity profiling. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working in pharmaceutical R&D and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity B in Paroxetine HCl Hemihydrate API.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of the drug substance and product.
• Research and Development: Facilitates process chemistry research to understand and minimize the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Paroxetine HCl Hemihydrate Impurity B HCl
CAS No.	127017-69-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paroxetine Impurity B HCl; Paroxetine Related Compound B HCl; (-)-trans-4-(4'-Fluorophenyl)-3-[(3',4'-methylenedioxy)phenoxy]methyl]piperidine Hydrochloride Hemihydrate Impurity B HCl; Paroxetine Hydrochloride Hemihydrate Impurity B; Paroxetine HCl Impurity B; Paroxetine EP Impurity B HCl; Paroxetine USP Impurity B HCl; BRL 29060 Impurity B HCl
EINECS	Contact for details

Quality Control

Every batch of Paroxetine HCl Hemihydrate Impurity B HCl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant conditions.

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 impurity: ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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