Physical and chemical stability play a crucial role in the development, manufacture, and storage of a wide range of different product types, including pharmaceuticals, cosmetics, foods, and agrochemicals. However, there are some important distinctions in the origins of physical and chemical stability and in the experimental techniques used to measure them.
Microtrac offers products for all particle size analysis technologies.
Physical stability refers to the ability of a formulation to maintain its physical properties, such as appearance, texture, and particle size, over time. A great deal of effort and research has been put into preparation methods to improve the physical stability of formulations, as poor physical stability can lead to issues such as sedimentation, creaming, and caking.1 Physical instability can also have effects on the efficacy and even safety of the product.2
The overall physical stability of a product can be affected by various factors, including temperature, humidity, and light exposure. For example, during storage, shipping, or usage, exposure to high temperatures can lead to phase separation or variations in particle size, potentially affecting customer perception and satisfaction.3
Chemical stability, on the other hand, refers to the ability of a formulation to maintain its chemical integrity and potency over time. Integrity and potency refer to the molecular structures of the active ingredients in a product and whether they remain intact or unchanged. Chemical instability can lead to the degradation of the drugs or chemicals, which can affect its efficacy, safety, and shelf-life and is normally influenced by pH fluctuations, oxidation, hydrolysis processes, or bacterial activity.
Oxygen is highly problematic when it comes to chemical stability, as many drug molecules will react with oxygen, undergoing an unwanted chemical change. Reactions with oxygen lead to degradation and the formation of impurities and degradation products. Hydrolysis, which can occur on exposure to water, is a similar process that results in similar problems with the formation of new, unwanted compounds.
The phenomena contributing to chemical and physical stability in a sample differ; therefore, they require distinct measurement techniques for analysis.
Physical stability is usually assessed by visual inspection and long-term testing – it can take up to several months to assess whether a sample has any instabilities. Sedimentation and creaming tests are crucial in emulsions to assess whether particles remain suspended, settle to the bottom, or separate from the solution.4
Understanding particle size is crucial for determining and predicting physical stability and performing rheological measurements to understand the physical and mechanical properties of the final product. Conducting a comprehensive physical and long-term stability assessment can be a rather time-consuming process. Advanced analytical instrumentation can enhance testing throughput, provide greater objectivity, and allow for analysis of the product in its native state.
Chemical stability is usually assessed with analytical methods that are used for chemical identification, such as liquid or gas chromatography (HPLC – GC), mass spectrometry (MS), and infrared spectroscopy (FTIR). These methods help identify and quantify any degradation products or impurities that may form due to chemical instability. In addition, stability studies are conducted under various conditions such as temperature, humidity, and light exposure to determine the shelf-life of the drug product.
Cuando se trata de ensayos físicos, Microtrac dispone de la gama más amplia de analizadores de gama alta para ayudarle a realizar ensayos exhaustivos e informativos con el fin de mejorar sus gamas de productos.
La serie de instrumentos TURBISCAN cuenta con dispositivos para ensayos de envejecimiento, vida útil, dispersabilidad, redispersión, separación de fases, desestabilización y agregación, que cubren el perfil completo de las posibles inestabilidades físicas de su producto.
Microtrac reconoce los numerosos retos que plantea el trabajo en el laboratorio moderno, como la importancia de disponer de instrumentos que ocupen poco espacio y de un análisis rápido de los datos que acompañan a las mediciones. Por ello, todos los dispositivos TURBISCAN se han diseñado pensando en la velocidad y la eficiencia, con el objetivo de minimizar el espacio ocupado en el laboratorio. Vienen equipados con evaluaciones de estabilidad de un solo clic.
Diseñada para facilitar su uso, la gama TURBISCAN no requiere operarios expertos y ofrece condiciones de ensayo entre 20 y 60 °C, lo que garantiza la estabilidad de sus productos en cualquier entorno en el momento de su comercialización. La inclusión de análisis cuantitativos simplifica las comparaciones de productos y le permite calibrar la eficacia de las mejoras del proceso y los cambios de diseño.
Varios instrumentos, incluidos el TURBISCAN TOWER y el TURBISCAN TRILAB, pueden realizar diversos tipos de mediciones y ensayos, siendo el TURBISCAN LAB reconocido como el estándar mundial para el análisis de estabilidad.
Para averiguar cómo puede superar a la competencia acelerando sus estudios de estabilidad con datos más precisos y cuantitativos, póngase en contacto con nosotros hoy mismo. Nuestro equipo de expertos le explicará por qué el TURBISCAN podría ser la solución ideal para sus necesidades de ensayos de estabilidad física.
En última instancia, la elección de utilizar una solución de tamizado simple o invertir en difracción láser o análisis de imagen dinámica dependerá del volumen de pruebas, los presupuestos y el personal disponible y cualquier norma internacional específica o requisito del cliente al que se enfrente.
¿Por qué no se pone en contacto con Microtrac para realizar una consulta gratuita y averiguar qué solución le proporcionará el resultado y el rendimiento de la inversión que necesita?
