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February 15, 2019

Particle Size Analysis – To Trust or Not?

The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).
SokTiang Koh

Sok-Tiang Koh

Vice President, Scientific Affairs & Technical Services, Asia-Pacific

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