Long-term Stability Assay

Long-term stability assay of the drug substance or drug product is one of the key parameters in bioanalytical method validation in support of pharmacokinetics. Creative Biolabs is a leading provider of pharmaceutical analysis services. We provide our customers with one-stop long-term stability assay services to accelerate their drug discovery process.

Long-term Stability Assay

Stability assay is used to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, including temperature, humidity, and light. The chemical and physical properties of the drug substance and drug formulation determine the stability and shelf life of the product. These properties studies are designed to include testing of attributes that are prone to changes during storage and may affect quality, safety, and efficacy. Long-term stability assay provides evidence of how the quality of a drug substance or product changes in a long time and under the influence of environmental factors.

How to Conduct Long-term Stability Assay?

For long-term studies, the frequency of test points should be sufficient to establish the stability profile for a given period.

For drug substances with a proposed shelf life of at least 12 months, the frequency of testing at the long term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed shelf life.
For accelerated storage conditions, the test frequency is recommended to be a minimum of three-time points, including the initial and final time points (e.g., 0, 3, and 6 months) for a 6-month study. If there is an expectation (based on development experience) that the results of the accelerated test may be close to a significant change criterion, the additional test should be performed either by adding a sample at the final time point or by including a fourth-time point in the study design.
When testing under intermediate storage condition due to some changes under accelerated storage conditions, the test frequency is recommended to be a minimum of four-time points, including the initial and final time points (e.g. 0, 6, 9. 12 months) for a 12-month study.

Services

Creative Biolabs' advanced technology platform provides chemical stability, physical stability, and optimal solution properties for your target product. In terms of stability testing, we offer a variety of stability assay services, including long-term stability, to support customers at various stages of the development and validation process. We are continually researching and developing new technologies to remain at the cutting edge, with tailored services and solutions for every customer. In addition to long-term stability assay, other main assay services include:

Why Choose Us?

Single-point-of-contact. Creative Biolabs has all expertise within the same field, allowing clear and reliable communication.
Standard and custom services. We customize our study designs and protocols and develop specific and/or nonspecific methods according to customer's individual project needs.
Our fast and efficient work efficiency: Fairly priced tests, conducted precisely and reported quickly.

Our analytical testing laboratories are equipped with state-of-the-art equipment and our highly trained specialists provide excellent services and detailed solutions based on your specific needs. Please feel free to contact us.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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