Paroxetine (3S,4R)-N-Methyl Paroxol Impurity 2: A Reference Standard for Antidepressant Drug Quality Control

 Paroxetine is a selective serotonin reuptake inhibitor (SSRI) widely prescribed for depression, anxiety disorders, OCD, and PTSD. As one of the most established drugs in its therapeutic class, taken daily by patients often for extended periods, its manufacturing quality is held to strict regulatory scrutiny. Reference standards like Paroxetine (3S,4R)-N-Methyl Paroxol Impurity 2 play a key role in meeting that standard.

What Is This Impurity?

Paroxetine (3S,4R)-N-Methyl Paroxol Impurity 2, commercially referenced as Paroxol, is chemically identified as (3S,4R)-trans-(-)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine. It is a stereochemically defined process-related impurity associated with Paroxetine manufacturing, requiring precise analytical differentiation from the parent drug and its other stereoisomers during quality testing.

Key specifications:

  • CAT No: SZ-P012022
  • CAS No: 105812-81-5
  • Molecular Formula: C13H18FNO
  • Molecular Weight: 223.3
  • Availability: In Stock
  • Shipping Condition: Room temperature

Why This Standard Matters in Paroxetine Manufacturing

Because Paroxetine synthesis involves specific stereochemistry at the 3S,4R positions, stereoisomeric impurities like this one require especially rigorous characterization. Reference standards such as this support:

  • Analytical method development and validation (AMV): ensuring HPLC/LC-MS and chiral methods can reliably detect and separate this impurity from Paroxetine and its related stereoisomers
  • Quality control (QC) testing: confirming batch purity and stereochemical integrity during commercial production
  • ANDA filing support: providing the authentic reference material regulators expect for submission dossiers
  • Forced degradation studies: helping labs understand how Paroxetine behaves and breaks down under stress conditions
  • Unknown impurity identification: serving as a match standard when unexpected peaks appear during routine analysis
  • DMF filing support: supplying the documented reference material regulators expect in submission dossiers

Sourcing Paroxetine (3S,4R)-N-Methyl Paroxol Impurity 2

SynZeal's Paroxol reference standard is supplied with detailed characterization data compliant with regulatory guidelines, and traceability against USP or EP pharmacopeial standards can be provided based on feasibility. As with all SynZeal reference materials, it is intended strictly for laboratory, research, and analytical use, not for human consumption.

It is part of a broader Paroxetine-related impurity series that includes Paroxetine Hydrochloride, Paroxetine EP Impurities A, F, and G, and Paroxetine USP Related Compound F, which is useful for labs building a complete impurity library for this widely prescribed SSRI.

Explore More

For labs working across psychiatric and other therapeutic areas, it's worth browsing the full SynZeal product catalog, which spans thousands of pharmacopeial and non-pharmacopeial reference standards, metabolites, and stable isotope-labelled compounds across major therapeutic categories.

This article is for general informational purposes and does not constitute regulatory or medical advice. This compound is intended strictly for laboratory, research, and analytical use, not for human consumption. Product availability, CAS numbers, and specifications should always be verified directly on the manufacturer's website before ordering.

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