Stability Testing

Comprehensive Stability Testing Services

Thoughtful stability testing of drug substances, drug products and reference standards are crucial for ensuring the quality, safety, and efficacy of any compound destined for human use.

SK pharmteco’s analytical services team has the deep technical knowledge and specialized equipment needed to guide this process on behalf of our pharmaceutical and biopharmaceutical clients. We understand what data and documentation are needed for the project at hand, to avoid over-testing or delays. Our team closely adheres to stability guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which includes input from various regulatory bodies around the world.

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Elevated Analytical Services

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Top-Tier Analytical Infrastructure

We take great pride in our analytical services team and its ability to provide standalone value to our pharma and biopharma clients. Our experts have refined their processes using the top technologies and drawing on decades upon decades of analytical experience. Drug stability testing isn’t a side service –– it’s part of our core capabilities.

Transparent Collaboration

Outsourcing to SK pharmteco doesn’t mean losing control or visibility into how your analyses are performed or the data they ultimately generate. We’re a transparent partner that includes you in the process and listens to your needs first. Our project managers can adapt to the level of involvement you’re seeking, for a seamless and additive partnership.

A Partner in Innovation

SK pharmteco has a long history of innovating alongside our pharma and biopharma partners to help them achieve their development goals. When it comes to stability testing, we remain at the forefront of advanced modalities such as cell and gene therapies, developing custom methods and leveraging state-of-the-art equipment to help make new small molecule and biologic therapies a reality.

ICH Stability Studies with SK pharmteco

We perform everything from protocol and report writing to stress testing and forced degradation studies. All of these services are tailored to ICH guidelines for that specific modality, including the range of storage conditions. The stability of drug products, APIs, intermediates, and starting materials can also be tested in a variety of different stability conditions in accordance with ICH.

Interested in a quote for drug stability testing services?

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