Description

Atomoxetine Related Compound C (10 Mg) (n-Methyl-3-Phenyl-3-(p-Tolyloxy)Propan-1-Amine Hydrochloride) is a high-purity chemical reference standard, specifically a related substance of the active pharmaceutical ingredient Atomoxetine HCl. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists working in the pharmaceutical and contract research organization (CRO) sectors to ensure the purity, safety, and efficacy of drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific related compound during the analysis of Atomoxetine HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to establish acceptance criteria and ensure that drug substances and products meet stringent regulatory specifications for impurity limits.
• Stability Studies: Used as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability studies.
• Pharmacopoeial Testing: Applicable for testing against monographs in pharmacopoeias such as USP, EP, or BP, where control of specified and unspecified impurities is required.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.

Basic Information

Product Name	Atomoxetine Related Compound C (10 Mg) (n-Methyl-3-Phenyl-3-(p-Tolyloxy)Propan-1-Amine Hydrochloride)
CAS No.	873310-31-7
Molecular Formula	C17H21NO•HCl
Molecular Weight	291.82 (Free base: 255.36)
Synonyms	N-Methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride; Atomoxetine Impurity C; Atomoxetine Related Substance C; (R/S)-N-Methyl-3-phenyl-3-[(4-methylphenoxy)propyl]amine hydrochloride; LY-139603 Related Compound C; Tomoxetine Related Compound C; 1-Phenyl-3-(4-methylphenoxy)-N-methylpropan-1-amine hydrochloride
EINECS	Contact for details

Quality Control

This analytical reference standard is manufactured and handled under strict quality systems. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and ensure high purity. A comprehensive Certificate of Analysis (CoA) is supplied, detailing the results for identity, assay, purity, and specified impurities. Our quality commitment aligns with the needs of GMP-compliant pharmaceutical analysis, and we support our clients' regulatory requirements with full traceability and documentation.

Storage

Preserve in the original 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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.