When it comes to working in a laboratory, we all want to ensure our test results are as accurate as they can be. That’s why a lot of companies enlist some analytical testing services. What are they, though, and how do they work? It’s simpler than it might seem.
While some of the topics covered today with include some scientific jargon, I’ll try to keep it as readable as possible while still being accurate. I have faith, though, that many of the people interested in this will already have some familiarity with these processes. So, if you’re curious about how you may be able to utilize a service like this, stay tuned!
This one is for all of my chemists out there. Chromatography is the process of separating parts of mixtures and compounds, even if they are complex in nature. There are a lot of variances in this technique, but they almost all depend on what mobile phase is used.
What I mean by this is what agent is used to separate what is in the solid phase, which is usually the compound sent into the lab. There are liquid and gas types of this process, so find a lab that does what you prefer or be sure to request something specific.
You might want to look into this if you are looking to isolate a specific type of molecule. It could also be useful if you want to know what is in a specific mixture. Finally, some people utilize it as a tool for purification.
This is a process that can measure atomic weight as well as the mass-to-charge ratio. Why might you get this? Usually, it is performed to assist in identifying any molecules or substances that are unknown in a compound or mixture. This identification is critical in getting products out of their testing phases and onto shelves.
For these testing services analytical, there are at least three components in a spectrometer. This includes an ion detection system, an ionization source, and a mass analyzer. They work in tandem during preclinical testing phases to give you information that you need as you proceed with research and development.
While many of us do not realize it, water has a serious impact on pharmaceutical drugs. This is especially true for solids such as pills. It’s critical to know how your compound will interact with water, so that is why this kind of testing exists.
The nice thing is that usually, they will not only test with the liquid form, but also the gaseous form. Humidity levels and the number of vapors in a storage space for a drug can still have an effect on it, after all.
Before we can move on to clinical testing and eventual release of a pharmaceutical drug, we need to know as much as we can about it and its safety. This includes how it should be stored. Otherwise, there might be issues that arise.
This is one that surprised me, admittedly. I didn’t realize that some analysis companies go as far as to aiding in observation of your laboratory environments. They can check for certain environmental factors and determine how they impact production, for example.
The results generally include a microbiological profile being provided to you, which you can then use to tweak any protocols that you need to. If contaminants are on certain swabbed surfaces, this probably means you need to train your employees a bit better or at least increase emphasis on lab safety. You can even have any air or gas systems tested.
Drug Substance Characterization
It’s not surprising that there are a lot of regulations surrounding this industry, as you can see here, https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations. They need to be followed to the letter to ensure that your drug can enter the preclinical phase, let alone clinical and getting onto shelves.
Some analysis testing services can help with this. During the initial phases of your research, they can assist you in gathering any data you need for documentation and regulations. Additionally, they can ensure that the compound you have developed is within those industry guidelines.
Are These Tests Worth It?
You might be a bit hesitant to outsource your testing at first, but it’s a convenient way to save time and energy and to get the most accurate results possible. We shouldn’t let anything slip through the cracks when it comes to developing drugs for medical use. People’s safety and even lives are at stake, so we should take it very seriously.
So, if you’re manufacturing or developing these substances, consider getting them analyzed using one of the above techniques or a myriad of others. This list is far from exhaustive – explore your options and determine what is best for what you are creating.