Description

Paroxetine Ep Impurity H Hcl is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Paroxetine hydrochloride. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and assay of Paroxetine-related impurities in accordance with EP and other pharmacopeia monographs.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Serves as a system suitability standard and for preparing calibration curves in the routine QC testing of Paroxetine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Stability Studies: Employed to monitor the formation of degradation products in Paroxetine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Item	Details
Product Name	Paroxetine Ep Impurity H Hcl
CAS No.	503834-41-1
Molecular Formula	C19H21ClFNO3
Molecular Weight	365.83 g/mol
Synonyms	Paroxetine Impurity H Hydrochloride; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine Hydrochloride; Paroxetine Related Compound H HCl; Paroxetine EP Impurity H; UNII-7S8I5O5W5N; 1,3-Benzodioxol-5-ol, 5-[(3S,4R)-1-methyl-4-(4-fluorophenyl)-3-piperidinyl]methyl]-, hydrochloride (1:1); Paroxetine HCl Impurity H
EINECS	Contact for details

Quality Control

Every batch of Paroxetine Ep Impurity H Hcl is manufactured and tested under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR spectroscopy, and residual solvent analysis, to ensure it meets the high standards required for pharmacopeial reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified criteria.

Storage

Preserve in a 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 should be handled in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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