Description

Fluoxetine Ep Impurity C is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Fluoxetine Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product in compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is an essential reference standard for research, method development, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Fluoxetine-related impurities in API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing of Fluoxetine HCl to ensure compliance with EP, USP, and ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to monitor the formation of degradation products in Fluoxetine formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Fluoxetine Ep Impurity C
CAS No.	56161-72-9
Molecular Formula	C17H18F3NO
Molecular Weight	309.33 g/mol
Synonyms	N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine; 3-(Methylamino)-1-phenyl-1-[4-(trifluoromethyl)phenoxy]propane; Fluoxetine Impurity C; Fluoxetine Related Compound C; Prozac Impurity C; (RS)-N-Methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine
EINECS	Contact for details

Quality Control

Every batch of Fluoxetine Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity and residual solvent analysis.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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