|Water for Injection||Injection||2ml||1000.1350|
|Water for Injection||Injection||5ml||1000.1242|
|Water for Injection||Injection||10ml||1000.1243|
|Water for Injection||Injection||20ml||1000.1225|
|Water for Injection||Injection||250ml||1000.1648|
|Water for Injection||Injection||500ml||1000.1300|
|Water for Injection||Injection||1000ml||1000.1649|
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or
must be dissolved in an aqueous vehicle prior to injection.
Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which
contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in
single-dose containers to dilute or dissolve drugs for injection. For I.V. injection, add sufficient solute to
make an approximately isotonic solution.
Water for Injection, USP is chemically designated H2O.
The glass vial is a Type I borosilicate glass and meets the requirements of the powdered glass test
according to the USP standards.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene
and propylene. The safety of the plastic has been confirmed by tests in animals according to USP
biological standards for plastic containers. The container requires no vapor barrier to maintain the proper
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body
weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for
insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water for distribution depends
primarily on the concentration of electrolytes in the body compartments and sodium (Na+
) plays a major
role in maintaining physiologic equilibrium.
The small volume of fluid provided by Sterile Water for Injection, USP when used only as a
pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant
effect on fluid balance except possibly in neonates or very small infants.
INDICATIONS AND USAGE
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous,
intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be
Sterile Water for Injection, USP must be made approximately isotonic prior to use.
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Do not use for intravenous injection unless the osmolar concentration of additives results in an
approximate isotonic admixture.
Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for
dissolving the drugs to be injected, including the route and rate of injection.
Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected
precipitation or discoloration prior to administration.
Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for
Injection. It is also not known whether sterile water containing additives can cause fetal harm when