Description

Paroxetine Impurity 73 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Paroxetine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and regulatory compliance testing for Paroxetine-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Paroxetine Impurity 73 in API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Paroxetine.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports compliance testing as per USP, EP, or other pharmacopoeial monographs for Paroxetine.

Basic Information

Product Name	Paroxetine Impurity 73
CAS No.	1243647-61-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paroxetine Related Compound 73; Paroxetine EP Impurity I; Paroxetine USP Impurity; Paroxetine Process Impurity; (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine Impurity; Fluorophenyl Benzodioxolyloxymethyl Piperidine Impurity
EINECS	Contact for details

Quality Control

Our Paroxetine Impurity 73 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory needs with full traceability and stability data.

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. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.