API Testing and Excipient Testing

Compendial methods play a significant role in the evaluation and validation of active pharmaceutical ingredient testing. HMR Labs pride ourselves on our range of active and inactive ingredient testing services, assuring the quality, safety, and efficacy of drug compound formulations.

API and excipient testing is a fundamental tool to ensuring that all aspects of a drug product meet the required quality and regulatory standards.

Through a combination of advanced analytical techniques and compendial methods, HMR Labs are able to perform comprehensive testing which delivers reliable results.

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in-house scientists are personal project managers

Standard and custom developed testing methods

35+ YEARS OF PHARMACEutical testing experience

Expertise in API Testing and Excipient Testing

We understand that as a pharmaceutical testing provider, the role we play in ensuring the quality, safety and efficacy of ongoing drug substances and raw materials sourced by manufacturers and biotechnology organisations is crucial in ensuring the integrity of the pharmaceutical supply chain.

Not only must API and excipient testing methods provide complete data, but the techniques employed can also deliver comprehensive therapeutic performance insights.

Excipient Testing Requirements

Inert substances are naturally added to a pharmaceutical formulation to impart suitable bulking, consistency, and stability, thereby achieving the desired properties in the finished product. The testing of these inactive compounds is required to assess their impact on the quality and performance of the final formulation. This is why, HMR Labs employ a diverse range of advanced testing methods to ensure excipients contribute effectively to creating a compliant and effective pharmaceutical product.

It is a regulatory expectation to fully understand the effects of each ingredient on the performance of a finished drug product, excipient analysis plays an essential role in providing this insight.

Looking for a provider that is dedicated to capturing the data required for assurance of quality and compliance?

API Testing

The analytical testing of active pharmaceutical ingredients (APIs) requires adherence to regulations set by the MHRA, FDA and many other regulatory bodies.

In order to provide our customers with the exact information required, our API testing services can be tailored to evaluate conformance against all internationally recognised pharmacopeial standards including USP-NF, BP, Ph.Eur., and JP, helping to demonstrate testing compliance for a variety of markets.

HMR Labs house a range of state-of-the-art instruments to facilitate spectroscopy (AA, UV-Vis, FT-IR), chromatography (UHPLC/HPLC and GC) and mass spectrometry (ICP-MS) testing techniques required for identity, purity and potency testing.

Continued investment in our analytical facilities allows us to offer a tailored testing solution to meet your unique requirements. This allows for flexibility in testing approaches, sampling regimes and testing frequency.

active pharmaceutical ingredient API testing

Compendial Testing Methods of Active and Inactive Ingredients

Many pharmaceutical manufacturers and biotechnology organisations will partner with an outsourced testing provider for API and excipient testing.

Choosing the right provider of these services will ensure that the API and excipient testing is not only compliant with GMP regulations, but also meets specific testing program requirements.

HMR Labs prides itself on being a value-add pharmaceutical API and excipient testing provider by offering convenient testing turnaround times and access to our in-house expertise and compendial testing knowledge. We offer a valuable and cost-effective outsourcing solution which accounts for the full range of analytical techniques, instrumentation and technical guidance required to support your API and excipient testing programs.

HMR Labs have assisted numerous global manufacturers with the analytical assessment of their pharmaceutical raw materials, providing reliable data and insights on factors including:

Identity

Purity

Particle size

Moisture content

Residual solvents

Compatibility

Microbial contamination

We employ both standardised compendial testing methods in accordance with the official pharmacopeial monographs as well as bespoke customer or in-house methodologies. This ensures HMR Labs results are consistent and comparable from our testing laboratories to your manufacturing site.

Compendial methods facilitate regulatory compliance and our experience across the pharmaceutical sector ensures we can advise on appropriate method verification or validation and compatibility with novel compounds.

If you’re looking for a laboratory partner that offers transparent guidance and traceability to support your pharmaceutical ingredient release testing or manufacturing programs, HMR Labs would be delighted to hear from you.

HMR Labs have been continuously developing and improving our API testing services for over 35 years and are proud to have built a reputation during that time of offering a reliable, responsive and compliant pharmaceutical testing service.