Atomoxetine Hydrochloride – Impurity C (CAS No. 1643684-06-3): Essential Reference Standard for Pharmaceutical Analysis

Atomoxetine Hydrochloride – Impurity C (CAS No. 1643684-06-3): 

Atomoxetine Hydrochloride – Impurity C, also known as p-Methyl Atomoxetine Hydrochloride, is a highly specialized pharmaceutical reference standard. Supplied by Pharmaffiliates Pvt. Ltd. under Catalogue No. PA 28 35030, it plays a vital role in drug quality control, regulatory compliance, and advanced analytical testing.

Chemical and Physical Information

  • CAS Number: 1643684-06-3

  • Molecular Formula: C₁₇H₂₂ClNO

  • Molecular Weight: 291.82

  • Synonyms: (3R)-N-Methyl-3-(4-methylphenoxy)-3-phenylpropan-1-amine Hydrochloride, N-Methyl-γ-(4-methylphenoxy)benzenepropanamine Hydrochloride, N-Methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine Hydrochloride, Atomoxetine Related Compound C.


Storage and Handling Guidelines

To maintain its stability and integrity, Atomoxetine Hydrochloride – Impurity C should be stored in tightly sealed containers at refrigerated temperatures between 2–8 °C. As it is hygroscopic, proper handling is essential to prevent moisture absorption. The product is shipped under ambient conditions to ensure safe and convenient transportation.


Applications in Pharmaceutical Development

This impurity standard is indispensable in various stages of drug research and manufacturing:

  • Impurity Profiling: Identifying and quantifying related substances to ensure product safety.

  • Analytical Method Validation: Verifying the accuracy, precision, and reproducibility of testing methods.

  • Quality Control Testing: Meeting strict international pharmaceutical quality standards.

  • Stability Studies: Monitoring product behavior over time under different environmental conditions.

By using well-characterized impurity standards like this, pharmaceutical companies enhance the reliability of their analytical results, meet regulatory requirements efficiently, and streamline approval processes.


Pharmaffiliates’ Expertise Beyond Reference Standards

Pharmaffiliates is not just a supplier—it is a full-service end-to-end CRDMO provider in India for both small and large molecules. The company delivers:

  • Biologic Early Development Services in India – including advanced analytics for biologics and monoclonal antibody analytics.

  • Custom Synthesis – of pharmaceutical impurities, APIs, chiral molecules, stable isotopes, and metabolites.

  • Regulatory Documentation Support – with CMC data preparation, stability reports, and compliance filings.

  • Concept-to-Commercial CDMO Partnership in India – supporting the complete drug development lifecycle.

  • Spray Dried Dispersions CRDMO Expertise – for enhanced drug solubility and bioavailability.


Final Note

In modern pharmaceutical science, the role of impurity standards like Atomoxetine Hydrochloride – Impurity C cannot be overstated. From ensuring batch-to-batch consistency to meeting global regulatory expectations, it is a small but powerful component in the journey from drug discovery to market availability.


Comments

Popular posts from this blog

D-Leu7-Triptorelin (CAS 321709-37-9) | Peptide Impurity Standard by Pharmaffiliates

CAS 2857963-60-9: Premium Peptide Reference Standard for Advanced Research & QC

Exploring D-Leu-4-OB3 (CAS 289056-32-2): A Key Research Peptide with Scientific Potential