How are test specifications chosen for a product?

USP <797> states compounders must ensure products maintain labeled strength within monograph limits. The difficulty with determining limits (specifications) for compounded preparations is that there may not be a monograph to reference. In these cases, ARL assigns the specification by choosing them from a monograph that is closest to the product being tested. When there is not a monograph for a similar product, ARL defaults to 90%-110% per <797>. Clients may also provide their specifications at the time of sample submission. Contact ARL with additional questions.