There are many applications in the pharmaceutical industry that can benefit from the power of ion mobility spectrometry, but have not had access to the technique due to cost and performance limitations! Excellims has addressed this challenge with its HPIMS instruments for:
The FDA has written that “quality cannot be tested into products; it should be built in by design.” Process analytical technology (PAT) is defined by the FDA as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters which affect critical quality attributes.
The design and use of well-designed processes and analytical techniques for the testing of incoming materials, in-process materials, drug substances, and finished drug products, ensures confidence in pharmaceutical product quality.
Ion mobility spectrometry (IMS) sensitively and quickly detects trace chemicals - a key component of quality control in the pharmaceutical industry. However, the fact that IMS has typically only been available as an integrated feature of an expensive mass spectrometer (which can be cost prohibitive) and that the recent generation of instruments are somewhat labor-intensive, and lab-based, has meant that the power of Ion Mobility Spectrometry has remained out of reach to many.
Until recently, pharmaceutical manufacturing and processing lines could not benefit from IMS technology and therefore had to purchase a mass spec with integrated IMS. HPIMS, in contrast, combines ambient pressure high performance ion mobility technology with a patented intelligent vacuum system, bringing the technique out of the lab and to a wider range of pharmaceutical applications at line and on-line.
High performance ion mobility spectrometry provides IMS-based chemical detection on-line and at-line, It reduces analysis time from days to minutes, reducing cost and increasing efficiency.
Cleaning validation/verification is an FDA requirement at the conclusion of a pharmaceutical manufacturing run. The need to perform fast analysis of a large number of samples to check for the presence of leftover API or cleaning agents, is a requirement of the pharmaceutical industry that is addressed by HPIMS.
What is a Dissolution Study?
Dissolution studies measure the rate at which a drug compound gets absorbed into the body. This information is vital for many stages of drug development and is used to make critical decisions from formulations to final product approval.
And Why Use HPIMS for Your Dissolution Studies?
High performance IMS is a great alternative to HPLC or UV detection for dissolution studies because it is fast, versatile and specific. While some APIs lack UV chromophores or are difficult to distinguish from a tablet’s excipients in situ, HPIMS can separate, detect, and quantify APIs and excipients in a nearly immediate time frame with resolution comparable to HPLC.
HPIMS has the ability to run on-line as a continuous monitoring system. It can be integrated with a dissolution reaction vessel to display the progress of a dissolution in near real time; a small amount of solution diverted to an electrospray needle ionizes and enters the detector in a constant stream, generating instantaneous data that is viewed and saved at the desired intervals for quantification.
Learn more about the GA for dissolution studies
Why do Reaction Monitoring?
Reaction monitoring is a critical step in drug development as new formulations are created and processes are optimized. It is critical for process chemists to check the status of a reaction as quickly as possible, in order to avoid quenching it before completion or letting it run for longer than necessary.
And Why Use HPIMS for Reaction Monitoring?
The speed of high performance ion mobility spectrometry is a huge advantage over chromatographic methods for reaction monitoring. An LC run often takes several minutes to an hour, which means that by the time data is collected the information is already out of date. It may show, for example, that ten minutes ago the reaction was 80% to completion. On the other hand, HPIMS can produce data within a minute of sample collection.
Excellims’ Directspray source allows for direct sample injection off of a syringe; a chemist can draw a few microliters out of a reaction vessel and directly insert the syringe into the instrument for immediate analysis.
Learn more about HPIMS for reaction monitoring
Surfactant compounds, for example, are often difficult to analyze by standard chromatographic methods; they typically take a long time to elute off of LC columns and can easily contaminate equipment. HPIMS provides an attractive alternative to chromatography for the analysis of surfactants because it is fast, and does not require columns or tubing. HPIMS has been shown to separate and identify a variety of surfactants based on their gas phase ion mobilities in a matter of seconds.
[Download Surfactants Application Note]
Excellims has a HPIMS product to suit your pharmaceutical QC needs:
It is important to be able to differentiate between isomers for drug development purposes. Isomers differ in their pharmacokinetic and pharmacodyanmic properties, both of which affect drug safety and efficacy.
High performance IMS-MS can be used to separate structural isomers, a huge advantage in many stages of pharmaceutical development. The addition of HPIMS to orthogonal methods such as HPLC or MS adds versatility to a lab’s analytical toolkit, providing valuable information about molecular structure and enabling 2D confirmation.
[Additional reading: ‘Separation of biologically relevant isomers on an Orbitrap mass spectrometer using highâresolution drift tube ion mobility and varied drift gas mixtures’, Kaszycki et al.]
Learn more about the MA module for your mass spectrometer
It can:
"The introduction of ESI in HPIMS enables IMS to now be pushed back into the pharmaceutical industry. It is a way to introduce ionized molecules into the drift tube. This opens the application of IMS to non-volatile compounds."
