Shelf Life and Stability Tests in Pharmaceuticals: Ensuring Safety

Processes, Test Methods and Regulatory Requirements

Shelf life and stability testing of pharmaceuticals is a topic of great importance in the healthcare industry. To ensure that patients have access to safe and effective medicines, medicines must maintain their quality for a specified period of time.

What is the Shelf Life of Medicines?

Shelf life is the period of time during which a medicine maintains its efficacy and safety when stored under certain conditions from the moment it is manufactured. Shelf life refers to the period of time during which the drug can show its desired therapeutic effect without deterioration. This period is determined by comprehensive stability tests conducted by the manufacturer.

What are Stability Tests and Why Are They Performed?

Stability tests are tests that evaluate whether a drug can maintain its chemical, physical and biological properties under certain environmental conditions. These tests help ensure patient safety by identifying the risk of deterioration of medicines during storage. Stability studies are a process used to determine the shelf life and storage conditions of medicines.

Types of Stability Tests

Stability tests to determine the shelf life of medicines fall into different categories:

1. Real-Time Stability Tests: Medicines are stored under specified temperature and humidity conditions for a long period of time and changes are examined. It can usually take several years.
2. Accelerated Stability Tests: These are tests carried out in a short time under high temperature and humidity conditions. Used for long-term stability predictions.
3. Stress Tests: The drug is exposed to factors such as extreme temperature, light and oxygen to evaluate its durability. Degradation products and degradation mechanisms are determined.

Factors Affecting Drug Stability

Many factors affect the stability and shelf life of medicines:

• Temperature: High temperature can accelerate chemical reactions, leading to drug degradation.
• Humidity: As humidity increases, the physical and chemical structure of medicines may deteriorate.
• Light: UV rays can cause photodegradation in some medicines.
• Packaging Material: Inappropriate packaging may make it difficult to protect the medicine from external factors.
• pH Level: For drugs in solution, the pH value can directly affect stability.

Importance of Ensuring Shelf Life and Stability

Health authorities (such as the FDA, EMA and TİTCK ) require pharmaceutical companies to prove that the medicines they produce remain effective and safe for the specified shelf life. Without these tests, the safety of medicines cannot be verified and patient health can be jeopardized.

Nanolab offers a comprehensive service to ensure the safety and quality of pharmaceutical and pharmaceutical products. You can contact us to get information about the tests carried out in accordance with international standards, physical, chemical and microbiological stability.

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