Pharmaceutical Analysis for Small Molecules
Authors: Wiley Analytical Science | Last updated: July 2023
Overview
Pharmaceutical analysis is integral for the determination of the quality – including identity, purity, and strength – of drugs. In addition, related studies and programs are needed to assure the performance of the drug products.
Addressing these challenges requires analysts with an understanding of analytical chemistry and a thorough appreciation of pharmaceutical requirements.
Based on analytical results, product quality at each stage – whether this be raw material, in-process material, intermediate, drug substance, or drug product – determines the next course of action. In broader terms, the analytical results determine product quality in terms of a drug’s safety and efficacy.
From a good manufacturing practice (GMP) perspective, product quality, and the delivery of expected quality attributes, depends on the quality of analysis.
Quality of the analytical results depends on various factors, the most important of which are:
- Analyst
- Instrument
- Method
On this poster we present the most important techniques used for the characterization of products, the parameters of weighting balance to be considered during qualification, and their importance.
- Document type: Poster
- Page count: 1
- Read time: 15 minutes
Key Takeaways
- Parameters to consider when qualifying a lab balance
- Introduction to High-Performance Liquid Chromatography (HPLC)
- Main product characterization parameters
- Microbiological Methods
This Resource is Designed for:
Managers, Scientists and Technicians in
- Quality Control Labs
- Quality Assurance
- Analytical Excellence Labs
Applications Supported:
- Compliant Weighing
- Microbial Enumeration
- Balance Qualification
- Sterility Testing