<%@ CODEPAGE=65001 %> <%Response.Charset="UTF-8"%> Sterile Purified Water
Sterile Purified Water
H2O 18.02
NOTE—For microbiological guidance, see general information chapter Water for Pharmaceutical Purposes á1231ñ.
» Sterile Purified Water is Purified Water sterilized and suitably packaged. It contains no antimicrobial agent.
NOTE—Do not use Sterile Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection.
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 á71ñ: meets the requirements.
pH á791ñ: between 5.0 and 7.0 in a solution containing 0.3 mL of saturated potassium chloride solution per 100 mL of test specimen.
Ammonia— For containers having a fill volume of less than 50 mL, dilute 50 mL of it with 50 mL of High-Purity Water (see Reagents under Containers á661ñ), and use this dilution as the test solution; where the fill volume is 50 mL or more, use 100 mL of it as the test solution. To 100 mL of the test solution add 2 mL of alkaline mercuric-potassium iodide TS: any yellow color produced immediately is not darker than that of a control containing 30 µg of added ammonia (furnished by adding 1.76 mL of 1.0 N ammonium hydroxide) in 100 mL of High-Purity Water. This corresponds to a limit of 0.6 mg per L for containers having a fill volume of less than 50 mL and 0.3 mg per L where the fill volume is 50 mL or more.
Calcium— To 100 mL add 2 mL of ammonium oxalate TS: no turbidity is produced.
Carbon dioxide— To 25 mL add 25 mL of calcium hydroxide TS: the mixture remains clear.
Chloride— To 20 mL in a color-comparison tube add 5 drops of nitric acid and 1 mL of silver nitrate TS, and gently mix: any turbidity formed within 10 minutes is not greater than that produced in a similarly treated control consisting of 20 mL of High-Purity Water (see Reagents under Containers á661ñ), containing 10 µg of Cl (0.5 mg per L), viewed downward over a dark surface with light entering the tubes from the sides.
Sulfate— To 100 mL add l mL of barium chloride TS: no turbidity is produced.
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 0.1 N potassium permanganate, and boil for 5 minutes; where the fill volume is 50 mL or more, add 0.2 mL of 0.1 N 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.
Auxiliary Information— Staff Liaison : Francis P. Barletta
Expert Committee : (PW) Pharmaceutical Waters
USP28–NF23 Page 2035
Pharmacopeial Forum : Volume No. 30(4) Page 1317
Phone Number : 1-301-816-8328