Vraag
Gepost op: 29 maart 2026Can a dermal solution containing tetracaine, cocaine, adrenaline, and NaCl 0.9%—where tetracaine and cocaine powders are dissolved in adrenaline and NaCl and then sterile filtered—be stored outside the refrigerator for 6 months, considering that adrenaline itself has a 6-month shelf life at room temperature and UZ Leuven stipulates a 2-month refrigerated shelf life for this preparation, or is there a possibility it remains stable for 2 months at room temperature due to the sterile filtration, which is relevant for storage in emergency cabinets?
Antwoord
Gepost op: 29 maart 2026Stability and Shelf Life
When assessing the shelf life, a distinction must be made between chemical and microbiological stability. Tetracaine and cocaine are presumably stable in solution for six months at an optimal pH. However, the range for the pH value is limited by the presence of adrenaline. Because the adrenaline solution is acidic, it has a favorable effect on the stability of both local anesthetics.
Regarding microbiological shelf life, sterile filtration is not considered a full sterilization method by the European Pharmacopoeia. If this method is applied, the shelf life at room temperature is a maximum of two months.
Recommended Preparation Method
All ingredients in the composition are resistant to heat sterilization. To optimally ensure sterility, the following procedure can be followed:
- Pre-filter the solution through a sterile membrane filter into a vial (flapule).
- Close the vial immediately after filtration.
- Place the closed vial in the autoclave for 30 minutes (accounting for 10 minutes of heating time and 20 minutes of sterilization at the target temperature).
- Allow the contents to cool before removing the vial from the autoclave.
If the preparation is produced in this manner, a shelf life of six months can be assigned.
Related Products:Beantwoord door
Public user
Featured products
How can we help you?
