Long Term Shelf Life Stability Testing

IIRT undertake the project for the Shelf life of the products as well as the container content compatibility test. Shelf life refers to the period from initial preparation and packaging during which the technical grade pesticides or the formulation remains within its physical, chemical and toxicological specifications at the specified storage condition. It should meet the appropriate standards of identity, quality and purity of active ingredient maintain the environmental factors such as:

• Temperature
• Light
• Air
• Oxygen
• Moisture
• Carbon dioxide
• Other ingredients in the formulations

Chemical stability of pharmaceutical molecules is always a concern as it directly affects the safety and efficacy of drug product. As per the FDA and ICH guidelines:

1. There is a requirement of stability testing data to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors.
2. Knowledge of the stability of the molecule helps in selecting formulation along with packing. It provides proper storage conditions to meet shelf life.
3. This further ensures the prescribed standards of physical, chemical, therapeutic and toxicological specifications. Which finally, ensures the identity, strength, quality and purity of a formulation.

understand the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Other than these the product related factors e.g chemical and physical properties of active substance and of pharmaceutical excipient, the dosage form and its composition, the manufacturing process, the nature of the container closure system and properties of packaging material are additional factors affecting the same. Therefore, it becomes extremely necessary to study the stability study. The long term shelf life stability testing is done of these products which ensure that for how long and in what condition are these products suitable for the human consumption.

We here at Toxicity are renowned for the trusted long term shelf life stability testing. The testing done here is acknowledge widely. We assure that the material used careful separation of chromatographic separation. The solution for separation is made separately and accurately to assure high accuracy of testing. Both test solution reference solution is prepared and used for testing as per the product.

All our reports of investigation on long term shelf life stability testing is done after proper and complete investigation and discussion on the results.