What compounded drugs should be tested for bacterial endotoxins?
Any drug prepared from nonsterile drug components or from an intermediate compounded from a nonsterile component should be tested for endotoxin. Refer to USP Chapter <797> for more details. Some admixtures are incompatible with the LAL gel clot test method. Chemicals with known interference problems include acids, alcohols, phenols, chelators, surfactants, and some antibiotics. Normal dilution of the test sample may overcome minor interference problems. Each PyroTest kit includes a Positive Control to alert the pharmacist to interference from something in the test sample, vibration during incubation, or incorrect incubation time or temperature.
