Pharma, Pharmaceutics and Biotechnology Conference

Pharmaceutical analysis is the science behind application analytical techniques for determination of quality, safety, and efficacy of pharmaceutical products.

This chapter discusses the principles governing pharmaceutical analysis, thereby keeping it basically focused on drug development and the need to follow regulations.

This core of pharmaceutical analysis goes towards products containing active pharmaceutical ingredients and finished dosage forms. Analytical techniques are employed to ensure that drug products meet very demanding quality standards, thus the assurance that it is safe for patients.

Some of these include chromatography, spectroscopy, and mass spectrometry - each of which has unique advantages in the analysis of complex pharmaceutical formulations. For example, chromatography is highly utilized in separating and measuring the amounts of compounds in samples.

Presence of impurities can be detected besides quantitation of concentration levels of active ingredients. It's mainly helpful in pharmaceutical analysis as HPLC is sensitive and very accurate. Along the same lines, spectroscopy methods such as UV-Vis and infrared spectroscopy allow molecular structures to be identified and drug purities to be evaluated.

Quality control in pharmaceutical analysis ensures consistency between products and predefined specifications. An important element of method validation is that the analytical methods must be reliable, reproducible, and fit for purpose. Thus, method validation cannot be missing in the course of regulatory compliance since it ensures that products manufactured are in conformity with GMP and meet regulatory agencies' set requirements.

An important ingredient in pharmaceutical analysis is compliance with regulatory standards, which ensures that governments and health organizations conduct serious testing and documentation before allowing drug products into the market.

Thus, regulatory compliance will be covered during the session, including preparation of submission dossiers and implementation of quality assurance systems in line with regulatory standards. In fact, it even profoundly helps in formulating new drugs through detailed analysis.

Through this, researchers can devise the optimal formulation strategies, product stability, and excipient's effect on the performance of the drug.

The program will cover an overview of pharmaceutical analysis focusing on the importance of this analysis in quality assurance and safety of pharmaceuticals.

Participants will be able to know analytical methods up to date and best practices, as proposed, so that they know how to share knowledge appropriately in pharmaceutical research and development.