BRIEFING

 Water for Hemodialysis. This proposal is based on the version of the monograph official as of November 1, 2018. On the basis of comments received, it is being proposed to add Bacterial Endotoxins Test Using Recombinant Reagents 〈86〉, which uses nonanimal-derived reagents, as an alternative to Bacterial Endotoxins Test 〈85〉 for the following monographs: Water for Injection, Water for Hemodialysis, Pure Steam, Sterile Water for Injection, Sterile Water for Inhalation, Sterile Water for Irrigation, and Bacteriostatic Water for Injection. The bacterial endotoxin limit is unchanged.

 The user is responsible for reviewing the supplier's primary validation package and verifying product suitability for use in testing specific products or materials. This verification must include specific experiments to confirm that the method is suitable for its intended purpose under the conditions of use for the official article. The selected verification experiments should be based on assessing the complexity of the material to which the method is being applied. The user should refer to Verification of Compendial Procedures 〈1226〉. Regulatory authorities may require supplemental data before acceptance. An example of supplemental data may include a comparative study of the material tested by techniques described in this chapter and those in 〈85〉.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (GCCA: A. Hernandez-Cardoso)

 Case ID—SUB-2370