Oral drops

Definition
Oral drops are Liquid preparations for oral use that are intended to be administered in small
volumes with the aid of a suitable measuring device. They may be solutions, suspensions or
emulsions.
Visual inspection
Inspect the drops. Drops that are solutions should be clear and free from any precipitate. Evidence
of physical instability of drops that are suspensions is demonstrated by the formation of flocculants
or sediments that do not readily disperse on gentle shaking. Evidence of physical instability of drops
that are emulsions is demonstrated by phase separation that is not readily reversed on gentle
shaking. A change in colour (or cloudiness of solutions) may indicate chemical degradation or
microbial contamination of the drops.
Dose and uniformity of dose of oral drops
Into a suitable, graduated cylinder, introduce by means of the dropping device the number of drops
usually prescribed for one dose or introduce by means of the measuring device the usually
prescribed quantity. The dropping speed does not exceed 2 drops per second. Weigh the liquid,
repeat the addition, weigh again and carry on repeating the addition and weighing until a total of 10
masses are obtained. No single mass deviates by more than 10% from the average mass. The total
of 10 masses does not differ by more than 15% from the nominal mass of 10 doses. If appropriate,
measure the total volume of 10 doses. The volume does not differ by more than 15% from the
nominal volume of 10 doses.
Containers
Oral drops are normally supplied in suitable multidose containers that allow successive drops of the