Shelf life after opening

See Sect. 22.7 for the general approach. For standard preparations the storage temperature and shelf life of an unopened container and after opening (in use period) should be determined during the design phase. For non-standardised preparations with a reliable preservation but with an uncertain chemical or physical stability it is recommended to limit arbitrarily the shelf life after opening to a maximum of 1 month. 

Thus a great deal of pharmacy preparations will have a shelf life after opening that is shorter than in the intact package, for two main reasons. A relatively large part of pharmacy preparations are vulnerable to microbiological contamination, and caution in determining the shelf life is the consequence of the often limited amount of research on this subject. 

Change in shelf life after the initial opening Conditions to be met the studies must show that the specifications laid down for the end of the shelf life continue to be complied with. 

Shelf life (when necessary after reconstitution or opening the container for the first time)... 

Note for Guidance on Maximum Shelf-life for Sterile Products for Human Use After First Opening or Following Reconstitution CPMP, July 1998. 

Shelf life (as packaged for sale, after dilution and/or after first opening of the container, if necessary)... 

Finally, as for any pharmaceutical product, ophthalmic products have to be designed to be stable. Ideally, the product should be stable at room temperature over a shelf-life period of 2-3 years. Multidose products must also be stable, after opening the pack, over the period of use. If antimicrobial preservatives are included to maintain sterility over this period, the effectiveness of the chosen preservative has to be demonstrated. There must be a discard statement on the label of multidose products indicating that the contents must not be used after a stated period. Normally, this does not exceed 28 days after opening the pack, unless there is a good justification. 

Storage 12 mos shelf life when stored below 25 C in sealed containers keep container sealed after opening HardSil AR [Gelest]... 

Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products Note for guidance on Maximum Shelf-Life for Sterile Products after First Opening or following Reconstitution... 

Will the shelf life be different will active substances in parenterals that are tilled under nitrogen oxidize after opening ... 

For standard nasal preparations that are not chemically stable, the maximum shelf life must be indicated in the formulary. For chemically and physically stable fatty nasal ointments that contain water, the maximum shelf fife is set at 3 years at < 25 °C, (not in a freezer). The usage period after opening the container may be 3 months (see Sect. 22.7.1). 

For non-standard extemporaneous pharmacy preparations, the design must include attention to the way of storage, and the maximum shelf life and beyond-use period after opening. For preparations with uncertain or xmknown... 

Non-sterile but preserved vaginal solutions may have a shelf life of 3 years after preparatiOTi, if prepared according to a standard formula and chemically and physically stable. Once opened by the patient, such vaginal solutions can be assigned an in-use period of 6 months. A concentrate diluted by the patient should be kept only 24 h after dilution. A non-standardised preserved preparatirai should not be stored in the pharmacy because the maximal shelf Ufe of say 1 month, may be reasonably needed by the patient. A diluted concentrate may be kept for 24 h after dilution. Unpreserved n(Mi-sterile vaginal solutions may have a shelf life of maximal 2 weeks and they have to be stored in a refrigerator. 

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