Particle Size Distribution of Methylprednisolone Acetate Injectable Suspension

Project Description

LONG-TERM TESTING
Indian lab is required to determine the particle size distribution of Methylprednisolone acetate injectable suspension as per USP monograph. Method and specification is mentioned below

Method : Transfer 1 drop to a microscope slide, and spread it evenly, diluting with water if necessary, to decrease the density of the field. Examine the slide under a microscope
equipped with a calibrated ocular micrometer, using 400× magnification. Scan the entire slide, and note the size of the individual particles.

Specification :
NLT 99% of the particles are less than 20 μm in length when measured along the longest axis, and NLT 75% of the particles are less than 10 μm.