USP <788> <789> Method 1
Determining the number and size of sub-visible particles found in certain preparations, such as clear injectables, IV solutions, and ophthalmics is very important. If a particle is too large, it may cause harm to sensitive parts of the body in which it may be used. Also, it may plug up the delivery apparatus, thereby making complete delivery of the dosage inaccurate. Therefore, particulates must be measured in several types of preparations in accordance with the USP. There are limits for the number of particles in certain size ranges: ≥10µm, ≥25µm, and for ophthalmics ≥50µm which are allowed to be present in these formulations.
(USP <788> <789> Method 1)