​Preparation, Storage and Labeling of Drug and Chemical Formulations

Guideline

Preparation of formulations:

Diluents or vehicles must be specified in the animal use protocol. All components of a formulation must be pharmaceutical grade if available (as outlined in relevant IACUC policies). Methods for preparing formulations must prevent contamination that could adversely affect animal welfare or the interpretation of data.

The use of solvents will be evaluated on a case-by-case basis. Use of certain solvents may limit amounts, concentration, and routes of administration of agents due to the solvent’s potential for toxicity or irritation.

Where possible, prepared solutions that will be given parenterally must be passed through a syringe filter (0.22 um or finer) at the time of preparation. This can be done in the process of transfer to an injection vial. If there is any question about the sterility of a stored solution, it should also be filtered at the time of use. If filtering is not possible (e.g., nanoparticles), sterile components should be mixed using sterile technique (e.g., in a laminar flow hood or biosafety cabinet).

Compounds for oral administration do not need to be sterile; however, sterility might be warranted depending on the type of solution and how long it will be stored to prevent degradation or contamination.

Storage of formulations:

Proper storage of agents and formulations is important. Solutions must not be used if they are cloudy, discolored, precipitated, etc. The UW IACUC expects that formulations are stored in a manner that assures stability, sterility, and potency of the formulation. Methods for storing formulations must prevent contamination that could adversely affect animal welfare or the interpretation of data.

Storage in sterile injection vials is strongly recommended as the best option for storage of most injectable drugs. Storage of diluted drugs in 15 or 50 ml conical vials is not recommended, as it is extremely difficult to maintain sterility when they are repeatedly entered with a syringe and needle, outside of a biosafety cabinet. Sterile vials can be purchased from UW Drug Services (Pharmacy Drug Services – Compounding Pharmacy (uw.edu)).

Labeling of formulations:

Formulations (including secondary containers) must be labeled with the following information: name of the compound, concentration, date of preparation, and expiration date. The expiration date should be determined from the technical information available by the manufacturer. If unknown or unspecified, the standard duration expected would be one month or less. Alternate expiration dates may be considered on a case-by-case basis if supported by published scientific literature and approved by the IACUC.