Deutsch: Hydrolyse / Español: Hidrólisis / Português: Hidrólise / Français: Hydrolyse / Italiano: Idrolisi

Hydrolysis in the quality management context refers to a chemical process by which a compound is broken down into smaller components through the reaction with water. This process can significantly impact the quality, shelf life, and safety of various products, particularly in industries such as pharmaceuticals, food and beverage, and cosmetics. Managing the effects of hydrolysis involves careful selection of raw materials, control of manufacturing processes, and appropriate packaging and storage conditions to ensure product stability and integrity.


In quality management, the consideration of hydrolysis is crucial for maintaining the desired characteristics of a product. For example, in pharmaceuticals, hydrolysis can affect the potency and efficacy of drugs. In the food industry, it can impact the nutritional value, flavor, and texture of products. Therefore, understanding and controlling hydrolysis is essential for ensuring the quality and safety of products.

Hydrolysis reactions can be influenced by various factors, including temperature, pH, the presence of catalysts, and the chemical structure of the substances involved. Quality management strategies to mitigate the effects of hydrolysis include optimizing formulation to minimize reactive conditions, selecting appropriate packaging materials to reduce exposure to moisture, and controlling storage conditions.

Application Areas

Hydrolysis is a concern in several key areas, including:

  • Pharmaceuticals: Stability of active pharmaceutical ingredients (APIs) and excipients.
  • Food and Beverage: Preservation of nutrients, flavors, and textures.
  • Cosmetics and Personal Care: Stability of active ingredients in products such as lotions, creams, and shampoos.
  • Biotechnology: Stability and activity of biological products, including enzymes and proteins.

Well-Known Examples

An example of managing hydrolysis in quality management is the pharmaceutical industry's use of stability testing to predict the shelf life of drugs. This involves accelerated aging studies where products are exposed to conditions that promote hydrolysis to assess their stability over time. In the food industry, controlling the pH and moisture content during processing and storage can minimize undesirable hydrolysis reactions that affect food quality.

Treatment and Risks

To manage the risk of hydrolysis, companies may employ various strategies, such as using stabilizers or inhibitors that slow down hydrolysis reactions, packaging products in moisture-barrier materials, and maintaining controlled environments during storage and transport. However, there are risks associated with inadequate control of hydrolysis, including reduced product efficacy, safety concerns, and decreased consumer satisfaction.

Similar Terms or Synonyms

  • Degradation
  • Decomposition
  • Water-induced breakdown


In the context of quality management, hydrolysis is a critical chemical reaction that can influence the stability, efficacy, and safety of products across various industries. Effective management of hydrolysis involves understanding the factors that contribute to these reactions and implementing strategies to mitigate their impact, ensuring that products meet the required standards of quality and safety throughout their intended shelf life.


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