Product Introduction: Loratadine Impurity 18

CAS Number: 31255-57-9
Synonyms: 3-[2-(3-Chlorophenyl)ethyl]-2-pyridinecarbonitrile; Loratadine Impurity 18

Overview
Loratadine Impurity 18 is a significant chemical compound predominantly used for research purposes in the pharmaceuticals sector. As a known impurity in the antihistamine drug Loratadine, this substance plays a crucial role in quality control and analytical chemistry, allowing pharmaceutical manufacturers to ensure the integrity and safety of their products.

Chemical Properties
Loratadine Impurity 18 possesses a molecular formula of C16H14ClN and a molar mass of 273.75 g/mol. Its intricate structure features a chlorophenyl group attached to a pyridinecarbonitrile framework, which contributes to its chemical reactivity and stability. The compound is characterized by:

- Purity Standards: Manufactured according to stringent quality norms to meet regulatory requirements.
- Appearance: Typically exists as a crystalline powder, ensuring ease of handling in laboratory settings.
- Solubility: Moderately soluble in organic solvents, making it suitable for various analytical applications.

Applications
The primary application of Loratadine Impurity 18 is in pharmaceutical research and development, specifically in the synthesis and analysis of Loratadine. Its significance extends to:

- Quality Control: Essential in assessing the purity of Loratadine formulations, adhering to industry standards set forth by regulatory agencies.
- Analytical Chemistry: Used as a reference standard in chromatographic techniques, such as HPLC and GC, for detecting and quantifying impurities in complex mixtures.
- Product Stability Testing: Plays a vital role in studying the stability profiles of Loratadine and related compounds, thereby contributing to the development of safer and more effective medications.

Quality Standards
Loratadine Impurity 18 is manufactured following Good Manufacturing Practices (GMP) to ensure reliable and reproducible quality. It is subject to rigorous testing, including:

- Identification and Purity Testing: Using methods like HPLC to confirm its identity and quantify impurities.
- Consistent Batch Testing: Every batch is analyzed to meet specified quality parameters, ensuring compliance with international standards.

Conclusion
Loratadine Impurity 18 serves as a critical component in the quality assurance processes of pharmaceutical products containing Loratadine. Its role as both a byproduct in efficacy studies and a benchmark for impurity levels underscores its importance in developing safe and effective therapeutic solutions. For research and applications requiring precise standards in pharmaceutical analysis, Loratadine Impurity 18 is indispensable.

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