Project Description

Canada GMP Health Canada Pharmaceuticals Analytical Chemistry Laboratory needed for Propofol Testing: Globule Size by Coulter Counter determination

BP Monograph - Propofol Injection.
Globule size

Not more than 5000 globules greater than or equal to 2 µm per mL of a 0.01% v/v dilution in a filtered 0.9% w/v solution of sodium chloride. By means of suitable equipment, pass the solution through a 50 µm aperture and count the number of globules by monitoring the change in electrical current between two electrodes immersed on either side of the aperture (a Coulter Counter is suitable). Repeat the procedure using the 0.9% w/v solution of sodium chloride only to determine the background count.

Note: Light Obscuration instruments are NOT a suitable alternative (e.g. Hyac Royco)