Stability Studies and Purity Testing for Pharmaceuticals
Pharmaceutical analysis is the science involved in testing drugs for their identity, strength, and purity. The pharmaceutical science team at MRIGlobal is here to make sure you get the data you need when submitting a drug for approval with the FDA. With our regular internal and external audits and decades of GMP experience, you can trust the quality of our labs and scientists.
For the best possible pharmaceutical analysis near you, look no further than MRIGlobal.
Quality Pharmaceutical Analysis
Why is stability testing important?
Stability testing in pharmaceutical analysis is a critical part of establishing the safety and efficacy of the drug. Through stability testing, we provide evidence on how the quality of a drug changes with time under a variety of environmental influences. We can test for stability under different temperatures, humidity levels, and light levels as recommended by ICH (International Conference on Harmonization) or at custom conditions.
With stability testing, we determine the optimum conditions under which to store drugs for maintaining efficacy and shelf life. For example, consider the variety of COVID-19 vaccines that have been cleared by the FDA and administered since early 2021.
Differences in storing vaccines
The single dose Johnson & Johnson vaccine is stable for up to 2 hours at room temperature or 6 hours when refrigerated between 2C and 8C. Thawed, undiluted Pfizer vaccine doses were authorized to be stored between 2C and 8C for up to 5 days initially. Recently, the FDA authorized that the vials can be stored at those temperatures for up to one month. Without stability testing and continued analysis, doses of the vaccine could have been thrown out when they were still perfectly good to use.
A good example of why we need such detailed information is the storage and handling summary for the Moderna COVID-19 vaccine.
Some highlights from that summary include:
- The vaccine will arrive frozen between -50C and -15C. Examine the shipment for signs of damage. Check the TagAlert temperature monitoring device.
- If the left arrow points to a green checkmark: the vaccine is ready to use, store the vaccine at proper temperatures immediately.
- If the right arrow points to a red X: the numbers 1 and/or 2 will appear in the display. Store the vaccine at proper temperatures and label DO NOT USE! Call the phone number indicated in the instructions or your jurisdiction’s immunization program IMMEDIATELY!
- For storage in a freezer, store in the original carton protected from light. Do not store with dry ice or below -50C.
- For storage in a refrigerator, unpunctured vials may be stored in the refrigerator between 2C and 8C for up to 30 days. You cannot refreeze thawed vaccine. Punctured vials may be stored between 2C and 25C for up to 12 hours.
- Storage unit temperatures must be monitored regularly and checked and recorded at the beginning of each workday to determine if any excursions have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger with a detachable probe that best reflects vaccine temperatures. Check and record the temperature daily using a temperature log and one of the options below:
- Option 1: Minimum/Maximum Temperatures (preferred): Most digital data loggers display minimum and maximum temperatures. Check and record the min/max temperatures at the start of each workday.
- Option 2: Current Temperature: If the digital data logger does not display min/max temperatures, check and record the current temperature at the start and end of the workday. Review the continuous digital data logger temperature data daily.
Identification of unknown impurities
As the drug substance/product advances through development, the identification of unknown impurities becomes increasingly important. We use complex techniques to identify impurities in your drug product or drug substance. Some impurities are more dangerous than others, so identifying them is critical to your risk assessment. Identification of these unknowns are required once they meet a required threshold level. Generally this requires isolation of the unknown impurity via semi-prep HPLC followed by characterization high resolution mass spectrometry (HRMS) and two-dimensional nuclear magnetic resonance (2D NMR) spectroscopy. With this instrumentation at MRIGlobal, we are able to conduct the isolation and structural elucidation of these unknown impurities. The identity can then be confirmed by chromatographic analysis. Once the structure of the impurity is known, then it can be determined how best to obtain a reference marker for this material. Either via synthesis or by additional isolation of the impurity.
High resolution mass spectrometry and nuclear magnetic resonance spectroscopy are some examples of our valuable instrumentation used to assess chemical structure during identification. Identity can then be confirmed by chromatographic analysis alongside a synthesized impurity reference marker.
Assay development and validation for pharmaceutical analysis
We are well experienced in assay method development and validation to meet your early-phase and late-phase pharmaceutical product needs. Phase-appropriate validation allows us to establish the most suitable methods applicable to your drug during each stage of the drug development life cycle with the understanding that changes may be needed as the drug product progresses through the pipeline. With reliable methods, the outcome of our analyses will be as specific, precise, accurate, and sensitive as required at each stage.
Timeline of pharmaceutical analysis
Analytical method development and validation can be relatively straightforward, for example with a very stable small molecule active ingredient that is water soluble, UV-active, and in a capsule dosage form. On the other hand, analytical method development can be quite challenging, for example with a hygroscopic, light-sensitive peptide active ingredient that is an injectable drug product. Our pharmaceutical analysis group has decades of experience with a wide variety of active pharmaceutical ingredients and dosage forms, and the equipment and instrumentation needed to evaluate an array of chemical properties. The development and validation process can generally be completed within a few months, but may take longer to establish appropriate methods to support release and stability studies.
You don’t want to rush stability tests because of how important they are in determining the safety and efficacy of your product; however, with intermediate and accelerated stability storage conditions available, as well as custom conditions, you can use the data we collect early on to predict the long-term stability of your product. Because stability results depend on how the drug reacts to its environment over time, including interactions between degradants that form during storage, the value of the data obtained at the recommended storage condition is indispensable. Because of this, stability studies can take up to three years to complete.
The amount of time required for successful impurity identification depends on the complexity of the sample matrix and molecular structure of the impurity, as well as the concentration level of the impurity. Our team generally is able to complete impurity identification within a few months.
MRIGlobal’s pharmaceutical science group
Our pharmaceutical analysis group works as a team with our repository and synthesis groups, as well as with our independent quality assurance department that oversees and approves all GMP work performed by the technical groups.
Our team attracts a great deal of return customers. We have several clients that started with our pharmaceutical repository services, then came back to us for their custom synthesis and pharmaceutical analysis needs. The breadth of our services allows us to be a nearly one-stop shop for several clients, particularly those that are looking for a reference standard management program.
Why choose MRIGlobal?
As a not-for-profit institute that has been in business for more than 75 years, MRIGlobal is truly a rare contract research organization. You will be hard-pressed to find another CRO with the capabilities we have, especially in our convenient centralized location. We are more adaptable and flexible than other CROs.
In addition, we know how important it is to have a consistent supply chain for materials during times like these. We are a US-based, full-service pharmaceutical repository. We can bring in your drug substance, drug product, reference standard, and other clinical trial materials. We store everything per GMP regulations and, when you’re ready, we can distribute them to your research partners.
Our clinical trial support offerings are impressive. We provide:
- Supply management
- Receipt and distribution of materials
- Clinical label design and production
- Custom kitting
- Blinded samples preparation
Sharing our clients’ goals
Our proposal process for pharmaceutical analysis is important. We want to understand and meet your needs, as well as exceed your expectations so you’ll return to us with other exciting opportunities. Your goals will become our goals. We’ll work best with you by establishing a trusted partnership.
Our team is well-trained and experienced with pharmaceuticals, and they have longevity at MRIGlobal. Our people do a great job because they are passionate about science and engaged with the work.
In short, relationships are important to us. We work hard to build great relationships with our clients and team members.
MRIGlobal welcomes anyone to visit us if they are interested in learning more.
Work with MRIGlobal’s pharmaceutical sciences team
Are you a lifelong learner? Do you crave challenging and rewarding experiences that will keep you on your toes? Take your interest in pharmaceutical science and analytical chemistry to work with MRIGlobal! We are looking for scientists, engineers and staff who are committed to purpose-driven work and share our passion for making the world healthier, safer, and more sustainable.
MRIGlobal solves challenging problems through science, engineering, and program management. We are an independent organization dedicated to benefiting society and fostering a safe, healthy, and sustainable environment. If you want your life’s work to be a journey of exploration and discovery, visit the MRIGlobal’s Career Center.
Getting started with MRIGlobal
Contact MRIGlobal now and get started with trusted pharmaceutical analysis.
As a not-for-profit contract research organization, we are an objective partner driven to make our clients’ products successful. We specialize in defense, human health, pharmaceutical sciences, in-vitro diagnostics, energy and environment, agriculture, and global health.
To learn more about our work or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.
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