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Application note: An alternative method of drug‑excipient characterisation

An alternative test method that enhances detection of incompatibilities by significantly reducing testing time, improving testing throughput and reducing operator effort.

Developing new pharmaceutical products is complex and time consuming, as new drugs must meet specific testing standards to ensure their safety, efficacy and quality. Identifying the physical and chemical incompatibilities between active pharmaceutical ingredients (APIs) and excipients during early phase development is an essential step to maintain the target product’s critical quality attributes throughout the clinical process. Isothermal microcalorimetry is an alternative to conventional test methods that enhances detection of incompatibilities by significantly reducing testing time, improving testing throughput and reducing operator effort.

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