Stability Studies
Stability Studies
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 Study Sample management
We take responsibility for incubation of the samples, maintenance of the environmental conditions (Temperature and Humidity) and periodically withdrawal of within the stipulated time window for analysis and later compilation of the data for statistical evaluation to assign the shelf life.
Feedback on Packaging Material
We not only evaluate the degradation of Drug Substances or their degradation product but also let you know the possible interactions of Drug Substances with the Packaging material in which these will be delivered, transported and stored throughout shelf life.
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.
Significance of Stability Testing Services
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.
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
How Do You Perform a Stability Test?
Stability testing tests the drug stability and monitors changes in physical, chemical, and microbial characteristics.
Physical Changes: With the stability test, researchers monitor changes in the physical attributes of the drug when stored for specified durations. Key changes that are monitored include the change in color, water content level, change in pH, change in viscosity, presence of crystalline substances, and its difference in dissolution and disintegration properties from the day it was packed.
Chemical Changes: The stability protocol for pharmaceutical products, when analyzing chemical evidence, is to look for the presence of residual solvents, related substances, and any degradation by-products along with assay.
Microbial Changes: Stability studies prove that pharmaceutical drugs, when stored for long periods at room temperature and in temperature-controlled conditions, can lead to a change in the microbial level. In microbial stability studies of drugs, researchers look for the presence of pathogenic microorganisms and the effectiveness of added microbial preservatives, and any impact on the efficiency of the drug.
Types of Stability Studies
Real-Time Stability Testing
Retained Sample Stability Studies
Cyclic Temperature Stress Testing
Accelerated Stability Testing
