Test Services

Particulate Matter

BACKGROUND
Particles measured by this test are defined as insoluble, free floating substances that cannot be measure by chemical means. The presence of particles in solutions and parenteral injections is an indication that the active(s) and/or excipient(s) may have precipitated or crystallized. It is critically important to determine the number and size of particles, because if present they may cause blockages that could be detrimental to the health of the patient.

OUR METHODOLOGY
DYNALABS employs two method of measuring particulate matter.
USP <788> Light Obscuration Particle Count Test: Instrumental analysis using a laser to count and size each particle. Specifications relate to the size of the particle counted and the volume of the solution/injection being tested (see table below).

USP <797> Physical Inspection – Visual inspection of the sample held up against a lighted white and black background as specified in Finished Preparation Release Checks and Tests Section. The specification for this test is absolute (ie. None Detected)

FORMS TESTED

• Aqueous Injections and Solutions
  
• Oil Injections (Physical Inspection only)
  
• Medical Devices