INTRODUCTION

These procedures are provided to demonstrate that the content of aluminum (Al) does not exceed the limit given in the individual monograph of a substance labeled as intended for use in hemodialysis. Use Procedure 1, Procedure 2, or Procedure 3 as indicated in the individual monograph. Procedure 2 or Procedure 3 can be used in all circumstances, provided that suitability is demonstrated by meeting the Requirements for Procedure Validation.