Utilization period

Definition
This section has been translated automatically.

Time period within which a medicinal product may be used after the first opening. This time limit is necessary because microbiological stability may decline significantly after the first opening and the use-by period then ends before the expiry date. In the case of extemporaneous preparations, the date of manufacture and the first opening usually coincide or are close together. In all cases, the use-up periods are sufficiently long for the extemporaneous preparations.

Tables
This section has been translated automatically.

Pharmaceutical form	Shelf life condition	NRF *		FNA **		Notes
		weeks	Months	weeks	Months
Emulsions, suspensions, solutions (for cutaneous or rectal or vaginal use or for ingestion or mouth rinsing)	conserved		6		6
	unpreserved	1		2		strong dependence on pH-value, ingredients and storage temperature
	anhydrous		6

Solutions, external (ethanol content 15% g/g)					24

Hydrophilic creams and hydrogels (for cutaneous or rectal or vaginal application)	preserved, canned	4			3	Container for exceptional cases, e.g. incompatibility with tubes
	preserved, in dispenser cans		6			Normally preferred container
	canned, in tubes		12		12	Normally preferred container
	unpreserved in dispenser cans	1 (if stored in the refrigerator, the shelf life is 2 weeks)				strong dependence on pH value, ingredients and storage temperature
	unpreserved in tubes	1 (if stored in the refrigerator, the shelf life is 2 weeks)				strong dependence on pH value, ingredients and storage temperature

Lipophilic creams (for cutaneous or rectal or vaginal use or for ingestion)	preserved, canned	4			3	Container for exceptional cases, e.g. incompatibility with tubes
	preserved, in dispenser cans		6			Normally preferred container
	canned, in tubes		12			Normally preferred container
	unpreserved in dispenser cans	4				strong dependence on pH value, ingredients and storage temperature
	unpreserved in tubes	4				strong dependence on pH value, ingredients and storage temperature

Hydrophobic ointments and lipophilic gels (for cutaneous or rectal or vaginal use or for ingestion)	canned		6		6	Container for the exceptional case, e.g. for very high consistency
	in dispenser boxes		36			Normally preferred container
	in tubes		36		36	Normally preferred container