Tuesday, July 14, 2009

Granules for oral solutions or suspensions

Presentations of granules that are intended to be issued to the patient as granules to be swallowed
as such, to be chewed, or to be taken in or with water or another suitable liquid, are outside the
scope of this general monograph.
Granules for oral solutions or suspensions are multidose preparations consisting of solid, dry
aggregates of powder particles sufficiently resistant to withstand handling. They contain one or
more active ingredients with or without excipients and, if necessary, authorized colouring matter
and flavouring substances. They may contain antimicrobial preservatives and other excipients in
particular to facilitate dispersion or dissolution and to prevent caking.
After dissolution or suspension in the prescribed liquid, they comply with the requirements for Oral
solutions or Oral suspensions, as appropriate.
Visual inspection
Inspect the granules. Evidence of physical instability is demonstrated by noticeable changes in
physical appearance, including texture (for example, clumping of granules, presence of loose
powder). A change in colour may indicate chemical degradation or microbial contamination.

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