Packaging and storage— Preserve in suitable,
Labeling— Label it to indicate the method of
preparation and that it is not for parenteral administration.
between 5.0 and 7.0 in a solution containing 0.3 mL of saturated
potassium chloride solution per 100 mL of test specimen.
For containers having a fill volume
of less than 50 mL, dilute 50 mL of it with 50 mL of High-Purity
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.
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
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.
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
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
Auxiliary Information— Staff
: Francis P. Barletta
Expert Committee : (PW) Pharmaceutical Waters
USP28–NF23 Page 2035
: Volume No. 30(4) Page 1317
Phone Number : 1-301-816-8328