Analytical Method Validation as the First Step in Drug Quality Control

Sigrid Mennickent and Marta De Diego

A chapter in Quality Management and Quality Control - New Trends and Developments from IntechOpen

Abstract: The authors have developed and validated some chromatographic methods with the aim of quantifying drugs as drug substance and drug product, suitable for stability and quality control studies, as at original products as at its remainder doses. The stability of a pharmaceutical is defined by its resistance to different chemical, physical, and microbiological reactions that may change their original properties. The stability of a pharmaceutical product is closely related to its potency; therefore, whether the compounds are degraded, a decrease of the therapeutic effect or changes in their toxicological properties can be produced, affecting their efficacy and safety, which becomes important to maintain a stable pharmaceutical product and to have the analytical tools to demonstrate stability. Therefore, stability-indicating methods are required to the quality control of pharmaceuticals. Analytical methods presented here are useful stability-indicating methods to analyze drugs and have adequate linearity, precision, accuracy, selectivity, and LOD/LOQ values. The examples presented here are stability-indicating methods since they allow the determination of drugs in the presence of their degradation products, according to the International Conference on Harmonization (ICH) guidelines.

Keywords: drug stability; stress testing; method validation; stability-indicating methods; drugs (search for similar items in EconPapers)
JEL-codes: L15 (search for similar items in EconPapers)
References: Add references at CitEc
Citations:

Downloads: (external link)
https://www.intechopen.com/chapters/65518 (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:ito:pchaps:176528

DOI: 10.5772/intechopen.82826

Access Statistics for this chapter

More chapters in Chapters from IntechOpen
Bibliographic data for series maintained by Slobodan Momcilovic ().