Suspensions and emulsions are shaken before their contents are withdrawn and the density determined. Oily and viscous preparations can be heated, if necessary, according to the instructions on the label, and shaken well just before removing the contents. The contents are then cooled to 20-25 °C before measuring the volume.
Select 10 container if the nominal volume is 1 ml or more, 3 containers if the nominal volume is more than 10 ml and less than 3 ml, or 5 containers if the nominal volume is ml or less. Separately withdraw the total contents of each container selected and fitted with a 3-gauge needle at least 2.5 cm long, the capacity of which does not exceed 21 times the volume to be measured. Evacuate any air bubbles from the syringe and needle, then empty the contents of the syringe without emptying the contents of the syringe into a standard dry cylinder (rated to contain rather than deliver specified volumes) large enough to at least occupy the volume to be measured. 40 percent of graduate volume. Alternatively, the volume of the content in milliliters can be calculated as the mass in grams divided by the density.
For containers with a nominal volume of 2 ml or less, the contents of a sufficient number of containers can be pooled together to obtain the volume required for measurement, provided that a separate, dry syringe assembly is used for each container. The contents of containers of 10 ml or more can be determined by opening them and pouring the contents directly into a graduated cylinder or tared beaker.
The volume may not be less than the nominal volume for individual containers, or the sum of the nominal volumes for containers with a nominal volume of 2 ml or less, taken collectively.
Multi-Dose Containers
For injections in multi-dose containers labeled to deliver the specified number of doses in the specified volume, select a container and proceed as indicated for single-dose containers using the same number of individual syringe assemblies for the indicated number of doses. The volume is such that each syringe delivers no less than the indicated dose.
Our organization, EUROLAB, provides testing services by our professional engineer staff to enterprises within the framework of laboratory testing services, within the scope of the test standard for the extractable volume of parenteral preparations 04/2010:20917.
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