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Extractables and leachables analysis of pharmaceutical products

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Extractables and leachables analysis of pharmaceutical products

A crucial undertaking when releasing pharmaceutical products for the market, is to determine the purity of the final product, necessitating the need to determine its impurity profile. Traditionally, this was concerned only with those impurities arising...

The impact of particles on pharmaceuticals

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The impact of particles on pharmaceuticals

Sometimes it's the smallest details that have the biggest impact on pharmaceutical performance. That's certainly true when it comes down to the properties of particles and their impact on pharmaceutical performance. Subtle changes in particle...

The role of dissolution in drug development

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The role of dissolution in drug development

Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability...

Method development – why it matters to get it right

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Method development – why it matters to get it right

In an industry that is seeing increasing levels of outsourcing, the contract research organisation (CRO) needs to have proven experience in both the pragmatism and flexibility of method development and a regulatory background in validation.