
Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.
Paul Kippax is a product manager, Laser Diffraction, Malvern Instruments Ltd., Enigma Business Park, Grovewood Road, Malvern Worcestershire, UK WR14 1XZ, Paul.Kippax@malvern.co.uk.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

A diverse range of particle sizing solutions is available, from techniques for the characterization of complex formulations through to online PAT tools for real-time measurement.

The way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.

One particularly crucial parameter for nasal sprays is the size of the droplets produced during actuation, which can potentially impact bioavailability.

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