Analytical work for drug substances and drug products

In a pharmaceutical program, analytical methods carry a lot of weight. They decide whether a batch is released, whether a stability study passes, and whether the data in your filing can be trusted. Our analytical laboratory develops and validates methods for both active pharmaceutical ingredients (APIs) and finished drug products, and our team plans that work around where your program is in development.

Services

Method development. We design methods to measure assay, impurities, degradation products, residual solvents, and other attributes your product needs. Our scientists have experience with techniques including HPLC, GC, MS, and ICP. In-house testing also includes dissolution, Karl Fischer moisture, particle size, microbial limits, and preservative efficacy.

Method validation. We validate methods to the level your phase requires, covering characteristics such as specificity, accuracy, precision, linearity, range, and robustness.

Phase-appropriate CMC methods. Early-phase methods are built to be fit for purpose. As a product advances, we expand and validate them to support later clinical phases and commercial release.

Stability studies. We design and run stability programs to support shelf life and storage conditions.

Process analytical technology (PAT). Because our analytical scientists work alongside our process development team, we can develop, deploy, and qualify PAT tools that monitor a process while it runs.

Method transfer. We prepare methods and documentation so they can be transferred to a quality control laboratory or manufacturing site.

Documentation. We provide turnkey documentation, including method reports and validation reports, to support your CMC package.

How this differs from our OTC and nutraceutical analytical work

The analytical principles are the same across industries, but the expectations differ. Prescription drug programs need phase-appropriate validation, characterization of the drug substance, and data built for regulatory submissions. Our OTC analytical development work focuses on meeting the requirements for over-the-counter drug products, and our nutraceutical analytical testing focuses on label claims, contaminants, and supplement quality. If your product could fall into more than one category, we can help you plan the analytical work for each.

Experience behind the lab

Members of our team have more than a decade of experience developing and running HPLC, ICP, and sample-preparation methods in an ISO environment. That experience includes work on United Science’s own products, which gives our analysts a practical view of how methods hold up in routine use. See our team.

Frequently asked questions

Can you validate a method we already have?

Yes. We can review, improve, and validate existing methods, or develop new ones if needed.

Do you perform cGMP release testing?

Yes. Our laboratory performs cGMP release and stability testing at our FDA-registered facility in Osceola, Wisconsin.

Do you work on APIs from natural sources?

Yes. Our analytical work supports botanical and natural-product APIs alongside synthetic ones, often in combination with our synthesis and extraction services.

How long does method development take?

It depends on the product and the attribute being measured. We will give you a timeline after reviewing your material and requirements.