The endotoxins limit table is out of date due to the increase in numbers of dosage (regimes) and drug strengths since the publication of the 1987 Guidance. The appropriate way to establish the endotoxins limit is to use the calculation methods provided in the USP or AAMI standards. Monograph limits may also not account for current product strengths or dosage regimes; these should also be checked using the calculations recommended in the standards.
If there are several components in a finished product, then the overall endotoxins limit for parenterally-administered products should not exceed the overall threshold limit specified in the USP <85> Bacterial Endotoxins Test, regardless of an individual component endotoxins limit. Intrathecally-administered products, ophthalmics, or devices (see question 11 for devices) may have endotoxins limit requirements that are not based on the calculation for parenterally administered products. FDA encourages firms to check with the appropriate office or review division about these products.
