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Question

Posted on: March 6 2013

A pediatrician prescribes Stesolid 10mg ampoules. These are difficult to enter from abroad.

The international pharmacy in Venlo does not supply them because of the opium law. On my suggestion to make the magijet, he says to me that he knows from a pharmacist that this preparation is only lasting for 4 months. Is there any information about shelf life, which I can convince him to do? The composition reads:
R/Diazepam 10mg
Ethanol 0.2 ml
propylene glycol 0.8 ml
Benzo ë acid 2.4 mg
Na-benzoate 97.6 mg
benzyl alcohol 30mg
Water for injections ad 2ml
Benzo ë acid and benzyl alcohol are back in stock.

Answer

I found this:

Source
American Journal Emergency Medicine 2002, Volume 20, Pay 88-91
Stability or diazepam rectal gel in ambulance-like environments.
Alldredge BK, Venteicher R, Calderwood TS.
Department of Clinical Pharmacy, University of California, San Francisco, CA, USA.

Abstract
The Objective of the present study was to evaluate the stability of diazepam rectal gel (Diastat) in various conditions of temperature and light exposure as might be found in ambulances. Three lots of Diastat (Xcel Pharmaceuticals, San Diego, CA) in various fill/syringe configurations were evaluated in controlled conditions of a freeze-thaw cycle, hard freeze (-30 degrees C for 72 hours), extreme light exposure (1.000 ft candles for 1 month), and Long-term evaluation at either 30 degrees C or 40 degrees C. In the various configurations and tests, diazepam concentration always exceeded 95% of label, with no changes of note in Fonterra excipients or physicochemical properties. The estimated shelf-life at 30 degrees C exceeds 48 months.

proposal 12 months, possibly with extra precaution: store in refrigerator if possible.