Guidance for Preparing and Storing Non-Pharmaceutical-Grade CompoundsSee policy UW-4123, Use of Nonpharmaceutical-Grade Compounds
- You must prepare your compounds in a sterile manner if you plan to inject them. This requires sterile constituents (e.g., sterile powder, sterile diluents, etc.), a sterile container, and a means of keeping the preparation sterile. Injection vials (available from RARC) are preferred as they make it easier to load a syringe and allow removal of the solution without exposing the contents to potential contaminants.
- Diluents or vehicles should be from the list of acceptable components (listed below).
- pH of solutions given by injection should be close to physiologic pH (~7.4)
- Containers must be labeled with the drug, concentration, date of preparation, and the date of expiration (usually 30 days after compounding, unless data is available that indicates efficacy and sterility last longer).
- Where possible, you should filter-sterilize solutions by using a 0.22 (or finer) at the time of preparation. This can be done when you transfer your solution to an injection vial. If there is any question about the sterility of a stored solution, you must filter it again at the time of use. If filtering is not possible (e.g., nanoparticles), sterile components should be mixed using sterile technique.
- Pyrogens, such as endotoxins, may cause fever and other physiologic changes. Sterility does not ensure that pyrogens are not present. Pyrogenicity is a potential experimental variable that researchers should be aware of when using non-pharmaceutical-grade substances, especially since it is impractical to remove pyrogens from small lots of prepared drug.
- Prepare only as much as you can use in a reasonable period of time. Drugs must be stored properly (e.g., freezer, refrigerator, in light-proof vials, etc.) You should not use solutions if they are cloudy, discolored, precipitated, or have altered in appearance since they were formulated.
- Please consult Animal User Requirement #5 for appropriate expiration dates (usually 30 days post-formulation) Animal User Requirement #5
- You must dispose of expired drugs properly. If not discarded, expired drug containers must be labeled “EXPIRED—AWAITING DISPOSAL—DO NOT USE IN ANIMALS” and stored separately from drugs in use.
- Distilled water
- PSS (0.9% NaCl), PBS, balanced salt solution (e.g., Hanks)
- 60% (v/v) propylene glycol
- 0.5% (w/v) carboxymethyl cellulose
- 10% (v/v) Tween 80 (polyoxyethylene (20) sorbitan mono-oleate)
- 10% (v/v) ethyl alcohol
- 50% (v/v) dimethylformamide
- 50% (v/v) dimethylsulphoxide (DMSO)
- Cyclodextrins (e.g., 2-hydroxypropyl--cyclodextrin, Trappsol
- Polyethylene glycol--PEG-200 or PEG-300
Others can be approved on a case-by-case basis in an animal care and use protocol