Stability testing is a demonstration of the fact that the quality of a drug substance can fluctuate over a period or under diverse environmental factors like humidity and light. These tests are imperative to discern the shelf life of drugs.
The procedure is reliable, and it ensures the longevity of the product. They follow acceptable protocols to establish a secure testing environment. Stability testing focuses on the physical, chemical, and microbiological composition of the product.
This type of testing method occurs in real-time. They establish the storage conditions of these medicines on the label. To ascertain its shelf life under ambient lighting, they subject these specimens to definite doses of ultraviolet and visible light in a specifically devised chamber.
These are known as photostability chambers. It embarks an even light distribution and meets all the International Council for Harmonization and Food and Drug Administration requirements. ICH stresses the fact that there should be a continual temperature regulation to ensure no hot spots.
WHY IS STABILITY TESTING VITAL?
When we buy medicines, we can spot an expiration date on the label that is suggestive of accurate storage methods. These instructions can oscillate between keeping the drugs away from sunlight or storing them in the refrigerator. It is solely in the presence of this knowledge that we can prolong the shelf life of medicines.
If this information was absent, our medicines could go bad and have lethal ramifications upon consumption. It also helps in determining the packaging components. Followed by giving them an inkling regarding transportation conditions.
To give people this insight, they conduct rigorous testing systems to ensure the utmost security. Stability testing comprises a crucial segment of drug development and ratification processes. It determines the security and cohesion of the drug. Also, the chemical deterioration of the element can contribute to the diminished concentration of the drug.
TECHNIQUES TO CONDUCT STABILITY TESTING
The most universal approach for stability testing is real-time testing. They conduct forced degradation studies to corroborate the stability of the drug over time. There is a careful provision of knowledge concerning the product. They also ascertain if the chemical and physical properties show stability.
They investigate these products on two levels- long-term ambient storage and accelerated conditions. Every program centers on approved protocols. This includes quality, purity, safety, storage, and physical and chemical characteristics that may shift depending on the habitat.
The protocols establish coherent instructions concerning packaging, storing conditions, conditions the tests will be executed under, test durations, and so on. They conduct stability tests in the same container and packaging supplies as the end product.
In most cases, three validation batches are placed under a formal stability test. Although they advocate that an informal study should be ordered on the developing batches to save time and devise more efficient designs.
They also subject additional batches to scrutiny. This takes place under the scale-up method that is applying the same procedure to different output volumes. Pharmaceuticals arrive at optimum storage conditions and expiration dates to finish the process. They also list out other attributes pertaining to the drug. It is solely after attaining a mandate that they can sell these drugs outside.
The next type of testing method is accelerated testing. This concentrates on providing the higher temperatures and the temperature at which the product fails is established. This helps them present an inkling concerning its shelf life. It is a shorter method in comparison with real-life testing. Also Stability testing provides an assurance to the patients.
STEP BY STEP BREAKDOWN
1) The initial stages focus on accelerated and stress testing.
2) The next step is performing a stability test on scale-up batches.
3) Subsequently, they conduct stress testing on scale-up batches.
4) They conduct accelerated and long-term testing on products for registration.
5) They center the next step on recurrent stability testing.
6) Followed by investigating it.
Stability testing has paramount importance in the field of pharmaceuticals. Their efficacy for providing stability is unmatched. By ensuring the integrity of a drug, they are making it safer for people. By establishing detailed information regarding storage and shelf-life people can make more informed decisions.
In the past few years, the regulations and requirements made by the ICH have become stricter. They cannot leave any room for errors because this can have fatal consequences on people. Global testing is one of the most trending stability tests in the market at this point.
People must also be wary and look out for these crucial details. They are important references made for our own benefit.