Packaging and storage- Preserve in single-dose glass or plastic, printed containers, of not larger than I-liter size. Glass  containers are preferably of Type I or Type II glass. 
Labeling- Label it to indicate that no antimicrobial or other substance has been added, and that it is not suitable for intravascular injection without its first having been made approximately isotonic by the addition of a suitable solute.  
USP Reference standards- USP Endotoxin RS. 

Bacterial endotoxins: lt contains not more than 0.25 USP Endotoxin Unit per mL. 

Sterility: It meets the requirements under Sterility Tests. 

Particulate matter: It meets the requirements under Small volume injections. 

Ammonia:  For Sterile Water for Injection in containers having a fill volume of less than 50 mL, dilute 50 mL with 50 mL of High-purity Water (see Reagents under Containers) and use this dilution as the test solution; where the fill volume is 50 mL or more, use 100 mL of Sterile Water for Injection 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 mg of added NH₃ in High-purity Water (see Reagents under Containers (0.6 ppm for Sterile Water for Injection in containers having a fill volume of less than 50 mL; 0.3 ppm where the fill volume is 50 mL or more). 
  
Chloride: To 20 mL in a color-comparison tube add 5 drops of nitric acid and 1 mI, 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 under Reagents in Containers) containing 10 mg of Cl (0.5 ppm), viewed downward over a dark surface with light entering the tubes from the sides. 

Oxidizable substances: To 100 mL add 10 mL of 2 N sulfuric acid, and heat to boiling. For Sterile Water for Injection 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  form, cool in an ice bath to room temperature, and filter through a sintered-giass filter: the pink color does not completely disappear. 

Total solids: Proceed as directed in the test for Total solids under Purified Water. The following limits apply for Sterile water for Injection in containers having a fill volume of less than 30 mL, 0.004%; where the fill volume is 30 mL or more, but les than 100 mL, 0.003%; and for a fill volume of 100 mL or more 0.002%. 

Other requirements: It meets the requirements of the tests for pH, Sulfate, Calcium, Carbon dioxide, and Heavy metals under Purified Water. 

PURIFIED WATER  

H₂0 18.02 
Purified Water is water obtained by distillation, ion exchange treatment, reverse osmosis, or other suitable process. lt is prepared from water complying with the regulations of the Federal Environmental Protection Agency with respect to drinking water. lt contains no added substance. 
  
[NOTE]- Purified Water is intended for use as an ingredient in the preparation of compendial dosage forms. Where used for sterile dosage forms, other than for parenteral administration, process the article to meet the requirements under Sterility Tests, or first render the Purified Water sterile and thereafter protect it from microbial contamination. Do not use 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- Where packaged, preserve in tight containers. Where packaged, label it to indicate the method of preparation. 

pH :  between 5.0 and 7.0, determined potentiometrically in a solution prepared by the addition of 0.30 mL of saturated potassium chloride solution to 100 mL of test specimen. 

Chloride: To 100 mL add 5 drops of nitric acid and 1 mL of silver nítrate TS: no opalescence is produced. 

Sulfate: To 100 mL add 1 mL of barium chIoride TS: no turbitity is produced. 

Limit of ammonia:  To 100 mL, add 2 mL of alkaline mercuric potassium iodide TS: any yellow color produced immediately is not darker than that of a control containing 30 mg of added NH₃ in High Purity Water (see under Reagents in Containers) 0.003 ppm. 

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. 

Heavy metals:  Adjust 40 mL of purified Water with 1N acetic acid to a pH of 3.0 to 4.0 (using short-range pH indicator paper), add 10 mL of freshly prepared hydrogen sulfite TS and allow the liquid to stand for 10 minutes; the color of the liquid, when viewed downward over a white surface , is not darker than the color of a mixture of 50 mL of the same purified Water with the same amount of 1 N acetic acid as was added to the test specimen, matched color comparison tubes being used for the comparison. 

Oxidizable substances: To 100 ml, add 10 mL of 2 N sulfuric acid and heat to boiling. Add 0.1 mL of 0.1N potassium permanganate and boil for 10 minutes: the pink color does not completely disappear. 

Total solids: Evaporate 100 mL on a steam bath to dryness and dry the residue at 105ºC for 1 hour: not more than 1 mg of residue remains (0.001%)