Requirements for specific types of liquid preparations for oral use Oral solutions

Definition
Oral solutions are clear Liquid preparations for oral use containing one or more active ingredients
dissolved in a suitable vehicle.
Visual inspection
Inspect the solution. It should be clear and free from any precipitate. A change in colour or
cloudiness of solutions may indicate chemical degradation or microbial contamination.
Oral suspensions
Definition
Oral suspensions are Liquid preparations for oral use containing one or more active ingredients
suspended in a suitable vehicle. For oral suspensions containing more than one active ingredient,
some of the active ingredients may be in solution.
Oral suspensions may show a sediment which is readily dispersed on shaking to give a uniform
suspension which remains sufficiently stable to enable the correct dose to be delivered.
Visual inspection
Inspect the suspension. Evidence of physical instability is demonstrated by the formation of
flocculants or sediments that do not readily disperse on gentle shaking. A change in colour may
indicate chemical degradation or microbial contamination.
Document QAS/07.191FINAL
page 6
Uniformity of content. For oral suspensions that are presented as single-dose preparations and that
contain less than 5 mg of active ingredient per dose or in which the active ingredient is less than 5%
of the total weight per dose, carry out the following test. Shake and empty each container as
completely as possible and carry out the test as described under 5.5 Uniformity of content for
single-dose preparations. In such cases, the test for Uniformity of mass prescribed above is not
required.
Labelling
The label on the container should include a direction that the bottle should be shaken before use.
Oral emulsions
Definition
Oral emulsions are Liquid preparations for oral use containing one or more active ingredients. They
are stabilized oil-in-water dispersions, either or both phases of which may contain dissolved solids.
Solids may also be suspended in Oral emulsions.
Oral emulsions may show evidence of phase separation but are readily redispersed on shaking.
Visual inspection
Inspect the emulsion. Evidence of physical instability is demonstrated by phase separation that is
not readily reversed on gentle shaking. A change in colour of emulsions may indicate chemical
degradation or microbial contamination.
Containers
When issued for use, Oral emulsions should be supplied in wide-mouthed bottles.
Labelling
The label on the container should include a direction that the bottle should be shaken before use.