Formulation in Pharmacy Practice   2nd Edition

EXPIRY DATES & STABILITY

 

Most of the formulations in Formulation in Pharmacy Practice (eMixt) have been assigned a maximum expiry date of 30 days from preparation.  This is an editorial decision based on the lack of knowledge of how these products perform during extended in-use conditions.  Chemical stability periods that were suggested by study authors are also provided so that pharmacists can judge their applicability.  It is the editor's view that 30 days is a reasonable maximum period to use an extemporaneously prepared oral liquid.  Pharmacists can exercise their judgement in assigning longer expiry dates, for example if they can perform further testing or observe the product in-use. In the monographs:-  Expiry date refers to the suggested maximum time period that the product should be stored or used following preparation.  The expiry date may be less than 30 days if the supporting evidence is poor, or if a published study has determined that the preparation is stable for a period less than 30 days.  Stability usually refers to the chemical stability of the preparation as determined in the published study.

Formulation in Pharmacy Practice 2nd Edition