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 are the different types of stability studies?
Two common types of stability tests are real-time and accelerated. Real-time tests are accomplished by storing pharmaceutical products according to the recommended conditions and checking or monitoring the product until it fails.
What are stability studies?
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Stability studies provide the supporting data that companies use to establish product storage requirements and expiration dating.
Intermediate Testing: Studies designed to moderately increase the rate of chemical degradation or physical change for a drug substance or drug product. Long-term Testing: Stability studies under the recommended storage condition for the re-test period of shelf life period for labeling.
What is a stability protocol?
A Stability Protocol is a detailed plan used to generate and analyze stability data in support of the shelf (expiry) life of a Drug Product or retest period of a Drug Substance in a single specified market. It should include time points and conditions employed, and methodology used to generate stability data.
What is the purpose of stability studies?
The purpose of stability testing is to provide evidence on how 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, and to establish a retest period for the drug substance or a shelf life for the drug
What is stability condition?
The stability condition is a requirement solely on the numerical scheme and does not involve the differential equation. If we define the error as the difference between the computed solution u and the exact solution of the discretized equation, that is, (11.75a) the stability condition can be written as. (11.75b)
What is meant by ship stability?
Ship stability is the ability of a ship to float in an upright position and, if inclined under action of an external force, to return to this position after the external force has ceased acting. Stability is not connected with a defined direction.
What is ICH Q?
Guideline. Q1B Guideline. Q1CStability Testing for New Dosage Forms. The ICH Harmonised Guideline was finalised under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines, and defines the circumstances under which reduced stability data can be accepted.
Why do we study stability?
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. Storage Condition Recommendation: Different products require different storage conditions.
WHO guideline stability study?
The Committee discussed and adopted the recommended modification of storage conditions published in the WHO guidelines for stability testing of pharmaceutical products containing well-established drug substances in conventional dosage forms to read 30°C (± 2°C) and 65% (± 5%) RH for real-time stability studies destined