Structural Identification of Drugs

In recent years, the global pharmaceutical industry has developed rapidly, and competition in the research and development of new drugs has become increasingly fierce. Natural products and microbial metabolites are extremely important resources for new drug development; identifying structurally novel active compounds from these as lead compounds, and using them as a basis for synthetic or semi-synthetic research into new drugs, is a key focus of investment in chemical drug R&D.

The pharmaceutical and biotechnology sectors remain vital components of the global healthcare system. Online mass spectrometers can be integrated into key manufacturing stages within the pharmaceutical industry, where they play an irreplaceable role; their applications in the pharmaceutical process are outlined below.

Mass spectrometry is one of the key methods for analysing the structure of drug molecules. Low-resolution mass spectrometry can be used to preliminarily determine the molecular mass of a compound through positive and negative ion detection modes, whilst high-resolution mass spectrometry calculates the elemental composition of a compound by determining its exact mass.

High-resolution time-of-flight mass spectrometry infers the molecular formula of a compound by determining its exact mass number; it offers advantages such as high sensitivity and rapid analysis, and has now become an essential tool for the structural identification of compounds in drug research and development.

Fermentation Control

During the fermentation process, bacterial growth and drug production take place under extremely stringent conditions. At several stages of this process, aeration rates, temperature and nutrient dosages are very closely regulated.

Online mass spectrometers are used to perform comprehensive, rapid and precise analyses of the inlet and exhaust gases from fermentation vessels to calculate the Respiratory Quotient (RQ), which is a key parameter for controlling bacterial growth and health.

The RQ value varies at different stages of the batch fermentation process, thereby enabling optimal and efficient drug production. Additional analysis of trace by-products allows for rapid process adjustments to prevent unwanted reactions.

A single ProC-TOF online mass spectrometer analyses multiple samples via a multipoint sampling valve; with sampling heads installed on the top of each fermenter, it can replace multiple infrared and oxygen analysers, offering greater cost-effectiveness and ease of management.

Solvent drying

Based on statistical data, pharmaceutical manufacturers can save significant time and energy by controlling the active pharmaceutical ingredient through the termination of the drying process at its endpoint.

To avoid process interruptions (such as sampling and analysing the product in the laboratory) and potential contamination of the entire batch, many manufacturers choose to extend the drying process excessively.

As the headspace is closely related to the solvent concentration in the material, monitoring the atmospheric composition above the drying material and analysing the headspace vapours allows the end point of the drying process to be determined. An online mass spectrometer enables you to view the concentration curve of the solvent over time and determine the exact point at which drying is complete.

Solvent Recovery

As large quantities of chemical solvents are used during the drying process, mass spectrometry is a viable and cost-effective analytical technique for solvent recovery applications. Offering analytical flexibility and ppb detection limits, mass spectrometry, as a single analytical method, can rapidly and flexibly analyse a large number of compounds.

The ProC-TOF online mass spectrometer greatly simplifies the control of solvent recovery processes in pharmaceutical plants; analyses are performed continuously across batches, ensuring that gases released into the atmosphere comply with environmental protection requirements.

The ProC-TOF online mass spectrometer plays a vital role in pharmaceutical manufacturing for solvent content monitoring, formulation development, excipient research, and quality assurance/quality control.