How do you test for drug stability?
The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as stability tests. Therefore appearance, assay, degradation products, microbiological testing, dissolution, and moisture are standard tests performed on stability test samples.
How long is stability testing?
Place the product at -10oC for 24 hours and place it at room temperature (25oC) for 24 hours. This completes one cycle. If the product passes three cycles then you can have a good degree of confidence in the stability of the product. An even more rigorous test is a -10oC to 45oC five-cycle test.
What is the difference between stability and shelf life?
Biopharmaceutical products in storage change as they age, but they are considered to be stable as long as their characteristics remain within the manufacturer’s specifications. The number of days that the product remains stable at the recommended storage conditions is referred to as the shelf life.
How do you determine the shelf life of a drug?
If long-term condition or accelerated condition data shows change then statistical analysis is used to estimate the shelf-life of the drug product. When the statistical calculations cannot be done by the data, the shelf life period can be defined 1.5 times of the period covered by the long-term data.
What are the types of stability testing methods?
The shelf life of a product is commonly estimated using two types of stability testing: real-time and accelerated. Stability testing allows you to rapidly assess the stability of your product and determine the projected lifetime and expiration.
What is shelf life of drug?
The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer.
What is long term stability testing?
real-time (long-term) stability studies Experiments on the physical, chemical, biological, biopharmaceutical and microbiological characteristics of a drug, during and beyond the expected shelf-life and storage periods of samples under the storage conditions expected in the intended market.
What is accelerated shelf-life testing?
1 Accelerated shelf-life testing (ASLT) ASLT aims to accelerate the rate of deterioration of the product without altering the mechanisms or order of changes seen in the product under normal storage conditions. Products spoiling because of microbial growth have other appropriate tests for prediction of microbial growth.
How can we predict shelf-life by accelerated stability testing?
An accelerated stability model for a second-degree polynomial degradation pattern was used. The shelf-life of the reagent, along with 95% lower bound confidence intervals, is predicted using the same pattern of degradation as well as the Arrhenius approximation.
What is stability and stability testing?
Stability Studies. Stability testing provides evidence on how the quality of a drug substance or product varies over a given time period and under the influence of environmental factors including temperature, humidity and light.
Why is stability testing important for pharmaceutical products?
Stability testing thus evaluates the effect of environmental factors on the quality of the a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions.
How is shelf life determined for pharmaceutical products?
Pharmaceutical products are assigned a shelf life which determines the time when a product is considered to be safe and effective under storage condition. Stability studies should be based on the basis of pharmaceutical R&D and regulatory requirements.
When to use accelerated stability testing for OTC drugs?
OTC drug products meeting the exemption of 211.137 (g) may utilize accelerated testing programs to support the requirement that they are stable for at least three years. Information obtained from old stock, not previously the subject of stability studies, may also be utilized.
Do you have to do stability testing for preservatives?
While we recommend that all other container sizes be subjected to stability testing, the fact that some may not is not necessarily a violation of CGMPs. Products formulated to contain preservatives to inhibit microbial growth should be monitored throughout their shelf life to assure the effectiveness of the preservative system.