Stability Testing

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Stability Testing

Stability testing is integral to developing new pharmaceutical products and active pharmaceutical ingredients, to establish their shelf life or expiry date. It is also equally important along with ongoing routine manufacturing to monitor product quality as a function of time. We provide a complete solution to your requirements of Stability Studies for Shelf-Life Estimation during

  • Product Development
  • Product Shelf life evaluation
  • Packing Material development & change over
  • For Product Registration in Global Markets
  • Critical supplier change
Stability Study Protocols and Stability Studies Plan

We l design Plan & Protocols for Stability Studies according to the Current Regulatory Requirements for your products in Indian, ASEAN /CIS /Non-CIS/ GCC/ African/ UK /EU/ US regions.

Stability Indicating Analytical Methods

We shall develop, design & validate the Analytical method for required test parameters to be used during stability study and further Regulatory submissions.

Most Economic Package in Industry with Quality

Unparalleled, most competitive and quite flexible package according to your business needs.

Accelerated Stability Testing Lab

Stability of a product means how long that product can be kept under normal conditions without degradation. As time passes, visible changes may occur. The changes may be physical, chemical or microbiological. The composition of the product varies over a period of time. Stability of the product is affected by various environmental factors. Stability of a product mainly depends on temperature, humidity, photostability, processing, handling and storage conditions.

In the pharmaceutical industry, Stability Testing is mainly of two types-Real-time stability testing and Accelerated stability testing.

Accelerated Stability Testing is done to determine the shelf life of finished products. As per the result, the expiry date of a particular product is fixed. Pharmaceutical products are kept under accelerated conditions. The changes under extreme conditions like temperature, light intensity and humidity are monitored. The test results are compared with the specified standards. After assessing the result, the shelf life of the product is established.

On the basis of results, packaging materials and containers are selected for the drug substance. The product can be kept for a long time without compromising its quality.

Significance of Stability Testing Services
What Is Stability Testing?

Stability testing is the statistical analysis of how long a pharmaceutical product can be stored without any change in its original chemical composition.

Pharmaceutical products when stored for long durations tend to undergo changes and release byproducts. Stability testing provides evidence on how certain pharmaceutical drugs can be stored at room temperature and in controlled conditions.

Why should you go for the stability testing of your product?

The physical, chemical and microbial properties of a pharmaceutical product may change under extreme storage conditions. That’s why; the shelf-life of a product has been studied during the stability testing.

The pharmaceutical industry conducts this testing to develop a new product and establish the shelf-life of a product. Here’s why stability study is important for the pharmaceutical industry.

  1. Shelf-Life Determination: The quality of a pharmaceutical product varies with time under temperature, humidity and light intensity. Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. This study helps to determine the shelf-life of that product. As per the report of the study, the expiry date of the product is fixed.
  2. Storage Condition Recommendation: Different products require different storage conditions. In the stability testing lab, storage conditions and changes in the substances are recorded. As per the stability study, the storage condition is recommended for a particular product.
  3. Elimination of Impurities: In stability testing, each ingredient has been analyzed under various environmental factors. So, it becomes easy to identify and eliminate any impurities that may be formed during the shelf life of the product.
  4. Product Development: Stability testing is a reliable way to study the effectiveness of a new product. This testing helps to assess the physical, chemical, therapeutic stability of a product. As per the study, R&D professionals redesign the existing product and develop a new product.
  5. Ensures Quality: Quality assurance is an integral part of the pharmaceutical industry. The product is kept under the influence of high stresses and the rate of decomposition is observed. Stability testing assures the purity of ingredients and the quality of the final product. The stability report ensures that the pharmaceutical product is fit for human consumption. This gives the companies the confidence to launch new products in the market. The chances of product recall may decrease.
  6. Packaging Material Selection: During stability testing, the pharmaceutical product is exposed to humidity and temperature. As per the effect of water activity and temperature on the product, packaging materials are chosen for the product. The ideal container must tolerate the stresses. The packaging should maintain the quality of the product during transportation and storage.
  7. Legal Approvals: Stability testing of the pharmaceutical products is required for regulatory approvals. If a product fails to meet the quality standards prescribed by ICH and WHO, the product will not get approval for commercialization.