The formulation of new products, or other particularly unique samples can present new problems in their chemical analysis. The interaction of chemical components in the matrix can present a challenge, and often requires research of the prior art to develop methods to analyse the components.
A method is a set of experimental conditions designed to create a good analysis of a particular sample. A goal a method is to detect, quantitate, identify and characterize the compound(s) of interest in a particular matrix.
Method development requires an intimate knowledge of product chemistry and analytical techniques/methodologies that can be used. Knowing the components of the matrix, the expected concentration of the active, the quantity of compounds in the sample and their chemical/physical properties is key to develop a robust method for analysis. The goals of the method should be defined, and the method should be able to meet the objective.
ACS has developed an array of methods for it’s clients in varying industries, often taking on complex problems from other laboratories. With thorough knowledge and experience in fourier transform infrared spectroscopy (FTIR), gas chromatography – flame ionisation detector (GC-FID), gas chromatography – mass spectrometry (GC-MS), UV-Visible Spectroscopy, liquid chromatography–mass spectrometry (LC-MS) and Ultra Performance Liquid Chromatography (UPLC).
Troubleshooting and Method development
ACS is very capable and experienced in dealing with troubleshooting defects in problems, and analyzing unique or novel matrices.
Development of novel or more robust methods of analysis is another strength of ACS. Thorough research of the previously developed methods serving as the initiation of the method development process.
Selecting the most suitable analytical technique, ACS is able to develop methods that can be adopted in-house. These methods are developed to run efficiently in a commercial laboratory environment.
Validation of analytical methods are required by various regulatory agencies to ensure the performance of the analysis technique.
Method validation is defined as, “process of demonstrating that analytical procedures are suitable for their intended use” (FDA Guidance for Industry). Key performance requirements such as accuracy, precision, reproducibility, linearity, limits of detection and limits of quantitation.
Validation ensures that there is minimum impact on the performance of the method that may be caused by varying method conditions.