H2O 18.02

Packaging and storage— Preserve in suitable, tight containers.

Labeling— Label it to indicate the method of preparation and that it is not for parenteral administration.

Sterility 71: meets the requirements.

Water conductivity 645— Perform Stage 2, Step 4 using a sufficient amount of water to perform the test. The conductivity is not more than 25 µS/cm for containers with a nominal volume of 10 mL or less at 25 ± 1; and not more than 5 µS/cm for containers with a nominal volume greater than 10 mL at 25 ± 1.

Oxidizable substances— To 100 mL, add 10 mL of 2 N sulfuric acid, and heat to boiling. For Sterile Purified Water in containers having a fill volume of less than 50 mL, add 0.4 mL of 0.02 M potassium permanganate, and boil for 5 minutes; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 minutes. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter: the pink color does not completely disappear.

Topic/Question	Contact	Expert Committee
Monograph	Gary E. Ritchie, M.Sc. Scientific Fellow 1-301-816-8353	(PW05) Pharmaceutical Waters 05
71	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance

USP32–NF27 Page 3872