The Science of Stability: Ensuring Your Product Stands the Test of Time

When a patient purchases medicine, they must be certain that the product will remain safe and effective until its expiration date. This certainty is not an accident; it is the result of exhaustive Stability Testing, a critical discipline within pharmaceutical quality assurance. At Bioaltus, stability testing is non-negotiable—it is the science that guarantees product longevity.

What Stability Testing Guarantees
Stability testing is a comprehensive program designed to determine how the quality of a pharmaceutical product varies over time under the influence of environmental factors such as temperature, humidity, and light. This testing allows us to:

Determine Shelf Life: Establish the correct expiration date for a product under specified storage conditions.

Identify Degradation Pathways: Pinpoint how and why a product breaks down, allowing us to adjust formulation or packaging to prevent it.

Verify Packaging Suitability: Ensure that the chosen primary packaging material effectively protects the drug substance.

Our Commitment to Data and Integrity
Our Quality Control labs are equipped with state-of-the-art stability chambers that meticulously control the required storage conditions (e.g., accelerated testing, long-term testing). Our commitment is to data integrity and scientific precision:

Rigorous Protocol: We follow strict protocols based on ICH (International Council for Harmonisation) guidelines for stability studies, ensuring the data is internationally accepted.

Continuous Monitoring: Samples are pulled and tested at pre-determined intervals (e.g., 0, 3, 6, 9, 12, 18, 24 months) for assays, impurities, and dissolution profiles.

Stability testing is the ultimate guarantee of product consistency. It’s how Bioaltus ensures that the promise of quality delivered today holds true for years to come.