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.
Quando se trata de testes físicos, a Microtrac possui a mais ampla linha de analisadores de última geração para ajudá-lo a realizar testes abrangentes e informativos para melhorar as suas linhas de produtos.
A série de instrumentação TURBISCAN possui dispositivos para testes de envelhecimento, prazo de validade, dispersibilidade, redispersão, separação de fases, desestabilização e agregação, cobrindo todo o perfil de possíveis instabilidades físicas em seu produto.
A Microtrac reconhece os muitos desafios de trabalhar em laboratórios modernos, como a importância de instrumentos de pequenas dimensões e análise rápida de dados para acompanhar as medições. Assim, todos os dispositivos TURBISCAN foram concebidos tendo em mente a velocidade e a eficiência, com o objetivo de minimizar a área ocupada no laboratório. Eles vêm equipados com avaliações de estabilidade com um clique.
Projetados para serem fáceis de usar, a linha TURBISCAN não requer operadores especializados e oferece condições de teste entre 20 e 60 °C, garantindo a estabilidade dos seus produtos em qualquer ambiente após lançamento no mercado. A inclusão da análise quantitativa simplifica as comparações de produtos e permite avaliar a eficácia das melhorias de processos e alterações de design.
Vários instrumentos, incluindo o TURBISCAN TOWER e o TURBISCAN TRILAB, podem realizar vários tipos de medições e testes, sendo o TURBISCAN LAB reconhecido como o padrão global para análise de estabilidade.
Para descobrir como você pode superar a concorrência acelerando seus estudos de estabilidade com dados quantitativos mais precisos, entre em contato conosco hoje mesmo. Nossa equipe de especialistas descreverá por que o TURBISCAN pode ser a solução ideal para as suas necessidades de testes de estabilidade física.
Finalmente, a opção entre adotar uma solução simples por peneiramento ou investir em uma análise por difração de laser ou dinâmica por imagem dependerá do volume de testes, do orçamento, do pessoal disponível e dos padrões internacionais específicos ou necessidades da clientela a considerar.
Que tal contatar a Microtrac para uma consulta gratuita a fim de definir qual solução proporcionará o resultado e o retorno de investimento necessitados?
