If you want to know the shelf life of a product, you can use two types of Stability Testing. Real-time and accelerated are two types of Stability Testing that allow you to determine your product’s shelf life. It will enable you to determine the expiration date of your product quickly. It is recommended to use in vitro diagnostics of diagnosing reagents such as enzymes, antibodies, and other such biologies.
The Different Types of Stability Testing
Real-time stability offers you to determine the shelf life of a product. It is based on the evaluation of your product and then decides its expiration date and projected lifetime. Real-life studies are based on your requirements and based on 6 months, 1 year, or 2-5 years time points.
If no real-time data is available, then accelerated Stability Testing comes into use. It helps to quickly re-manufacture or bring new products to the market at the earliest given time. It is a modified method that allows you to determine the expiration and life span of your product.
This method is achieved by placing the product under an elevated stress level like high temperatures and humidity. It is determined by the time frame required or expected for your product’s shelf life, which is 1 or 2 years.
Once accelerated testing is successful, you can release your product in the market with full confidence. It is an internationally recognized way of testing but is only useful when real-time testing can be used later on, on the same product. That is why it is essential to run real-time and accelerated testing side by side at the same time.
Open or in-use stability testing is used to copy the effects of a product’s everyday use, such as freeze or thaw cycles. It will help and guide the users to end the use of this product. Stability testing can be done on demand using a defined reporting system.
Testing for Drug Stability in Products
Stability testing provides evidence on how your product’s quality will vary over a certain period. It is tested under certain factors such as humidity, temperature, and light to test the product’s stability. The testing is usually done to determine a change in the product when kept in storage and how its quality and efficacy will get affected by it.
It generally covers three types of attributes listed below:
Melting point, appearance, water content, clarity, the color of the solution, viscosity, pH, dissolution and disintegration characteristics, particle size, or crystal modification.
Efficiency and growth in microorganisms of preservative contents such as antimicrobial and antioxidants preservatives.
Degradation product, assay, and related substances and residual solvents. For drug substances, a retest period of 12 months should be proposed. Test the product every 3 months when it is new and then every 6 months and once a year after the retest period ends. The frequency should be sufficient for retesting to establish a profile for stability.
Stability testing for intermediate storage conditions is a minimum of four times in a 12-month study, including the initial and final time points. For accelerated testing, frequency should be a minimum of three-time points, including the initial and final time points.
Pharmaceutical Stability Testing
Stability testing is essential in developing therapeutic drugs. Inactive or degraded products lead to inefficient products or might cause side effects and toxicities.
Additionally, it ensures that your product is safe even after staying in different types of environments. It provides your products’ safety regardless of their variety of influences, including light, humidity, temperature, and pH levels. Stability testing establishes storage, shelf life, and retest periods for pharmaceutical products.
Types of stability testing that you can use for pharmaceutical products, including:
- Photostability testing
- Stability storage
- Degradation of product testing
- Accelerated stressed studies
Stability testing is a part of developing technology. With rapid changes in technologies, we need immediate solutions. Hence we need quick ways to test our products with the ever-increasing demands of products. Therefore stability testing has proved to be beneficial not just for the pharmaceutical industry but every industry worldwide.
Since the demand for products increases, you need to have quick solutions to know when your product will expire or its shelf life. This is where stability testing comes into play to ensure you know all the information about your product before releasing it in the market. Once the study is successful, you can release the product with confidence in the market.