Description

Atomoxetine Ep Impurity C Hcl is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for the accurate identification, quantification, and monitoring of a specific impurity during the manufacturing and testing of Atomoxetine Hydrochloride, a medication used to treat ADHD. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D and production. Ensuring the integrity of your active pharmaceutical ingredient requires reliable and well-characterized impurity standards like this one.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Quality Control & Assurance (QC/QA): For the identification and quantification of Impurity C in Atomoxetine Hydrochloride drug substance and finished product batches.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity profile data.
• Stability Studies: Used to monitor the formation and levels of this specific degradation product under various stress conditions.
• Process Chemistry R&D: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.
• Pharmacopoeial Testing: Employed in testing to comply with pharmacopoeial monographs (e.g., USP, EP) for Atomoxetine Hydrochloride.

Basic Information

Product Name	Atomoxetine Ep Impurity C Hcl
CAS No.	1643684-06-3
Molecular Formula	C17H22ClNO
Molecular Weight	291.82 g/mol
Synonyms	Atomoxetine Related Compound C; (R)-N-Methyl-3-phenyl-3-(o-tolyloxy)propylamine hydrochloride; (3R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine hydrochloride; Atomoxetine Impurity C HCl; Atomoxetine EP Impurity C; Tomoxetine Impurity C Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Atomoxetine Ep Impurity C Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

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

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