Stability Testing in Analytical Chemistry | Research, Development, Test, and Evaluation
Stability Testing Capabilities
Stability testing provides the necessary information to develop safe, efficacious pharmaceuticals. Our repository and stability facility allows for thorough analysis of any drug materials.
Stability studies are used to generate evidence on how the quality of a drug substance or formulated drug product varies with time under the influence of a variety of environmental factors. These studies help determine the shelf life, purity, and storage needs for pharmaceuticals prior to commercial approval and ensure that the integrity of the active ingredient is safe for distribution. Our Pharmaceutical Sciences group has supported shelf-life stability testing for more than 50 years and our world-class team of highly experienced scientists make use of modern facilities, equipment, and instrumentation to fully support ICH compliant stability testing. Our team has extensive experience with a wide variety of intermediates, drug substances and drug products, performing analytical method development, validation, and stability testing for all phases of the drug product life cycle. Our quality systems are well-established to meet a wide variety of needs from early-stage preclinical/clinical development to commercial product support. MRIGlobal provides the analytical support and stability testing, be it for nonGMP, GLP or GMP studies, and takes your pharmaceutical from the early stages of clinical trials into the market.
Methods of Testing
MRIGlobal takes various approaches to ensuring thorough, accurate stability testing.
High-performance liquid chromatography allows us to separate, identify, and quantify each component within a material for an accurate assessment of purity.
For materials in the form of capsules and tablets, we use a dissolution apparatus to mimic the interior of a human stomach to effectively observe the material’s performance in that environment.
To analyze the moisture content of the pharmaceutical materials, our team uses Karl Fischer titration for its proven and robust results.
With thermogravimetric analysis and differential scanning calorimetry, we measure the effect temperature changes have upon the drug substance.
Our scientists utilize methods such as mass spectroscopy, Nuclear Magnetic Resonance, and Fourier Transform Infrared to analyze materials at a molecular level, measuring biomolecules and proteins present within the sample.
Our Staff
Expert scientists like Dr. Jon White have helped establish MRIGlobal’s reputation for excellence in stability testing.
MRIGlobal conducts R&D and cGMP-regulated projects for drug substances and drug products for government and commercial contracts. We successfully move client products through the phases of the complex FDA approval process.
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