Physical Stability is of utmost importance for developing therapeutic drugs. It has to be known as degradation or inactive goods lead to loss of efficiency and can cause unwanted effects as well as toxicities. Creative Biolabs provides a complete variety of stability evaluation services that adhere to International Conference on Harmonization ICH guidelines Q1A and Q1B, covering requirements for climate zones I to IV.The Purpose of stability testing is to offer evidence on how the efficacy and integrity of a drug substance or drug product including its packaging change with time under the influence of an assortment of physical, chemical or microbiological changes, such as temperature, PH, humidity, light, and radiations.
The procedure ensures that a pharmaceutical product is safe and effective, no matter different environmental conditions on earth. Moreover, our equilibrium testing service determines the shelf life, storage requirements, and retest intervals for active pharmaceutical ingredient API or finished pharmaceutical product.Creative Biolabs conducts several equilibrium studies and downstream analytical tests. Our capabilities include.
- Accelerated stress studies and forced degradation studies
- Photo stability testing
- Stability storage
- Degradation products testing
Accelerated Stress Studies and Forced Degradation Studies
The Goal of these two applications is intended to identify the Likely degradation products that further aids in determining the inherent stability of this molecule, demonstrating degradation pathways, and supporting the stability signalling procedures. The conditions used in forced degradation are more severe than those in accelerated degradation. We have got the flexibility to establish the standard and non-standard temperature/humidity requirements upon request, in addition to freeze/thaw cycle studies. Photo stability testing is an important part of stability testing to make certain your drug products will hold up when exposing to sunlight and UV rays. The Stability Testing products are put under controlled light sources lamps using output like standard daytime or white fluorescent lamps and near-W fluorescent lamps with wide spectrum output. Testing samples are compared with control trials to find out if significant changes occur. Creative Biolabs also offers forced degradation studies under many different lighting conditions.