Stability of a pharmaceutical product means how long it can maintain its original form without any visible changes under the influence various environmental factors like temperature, humidity, light.
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. Let’s discuss the importance of stability study in the pharmaceutical industry. Take a look.
- 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.
- Storage condition recommendation:Different products require different storage conditions. In stability lab, storage conditions and changes in the substances are recorded. As per the stability study, storage condition is recommended for a particular product.
- 3. Elimination of impurities:In stability testing, each ingredient has been analysed under various environmental factors. So, it becomes easy to eliminate impurities.
- Product Development:Stability testing is a reliable way to study the effectiveness of a new product. This testing helps to assess physical, chemical, therapeutic stability of a product. As per the study, R&D professionals redesign the existing product and develop a new product.
- Ensures Quality:Quality assurance is an integral part of the pharmaceutical industry. The product is kept under the influence of high stresses and 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 confidence to launch new product in the market. The chances of product recall may decrease.
- Packaging material selection: Duringstability 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.
- Legal approval:Stability testing of the pharmaceutical product is required for legal approval. If a product failed to meet the quality standards prescribed by ICH and WHO, the product will not get approval for commercialization.
So, you have known the importance of stability testing in the pharmaceutical industry.
Our stability testing lab is well equipped with a wide range of analytic techniques. We are working with top pharmaceutical companies in India. Our experienced team of professionals helps the pharmaceutical companies to determine the shelf-life of their products. We offer stability testing services at affordable package. If you want to take our service, call us at +91-8588851888.