Pharmaceutical WaterCompendialTypes1.Bulk formswhich are typically produced on site where they are used.A-Purified Water (PW)B-Water for Injection (WFI)2.Packaged Formswhich are produced, packaged, and sterilized to preserve microbialquality throughout their packaged shelf life.A-BacteriostaticWFIB-Sterile Water for InhalationC-Sterile Water for InjectionD-Sterile Water for IrrigationE-Sterile purified water
1-Bulk formsA-Purified water: (USP), is used in the preparation ofsome bulk pharmaceutical chemicals, do not usepurified water in preparations intended for parenteraladministration.Must be protected from microbial proliferation.
B-Water for injection,USP:conforms with the standards of purifiedwater,USP but is also pyrogen-free.Intended to be used in the manufacture ofinjectable products which are to besterilized after their preparation.Intended to be used for 24-hours after itscollection.It must be protected from microbialcontamination.
2.Packaged Forms A-Bacteriostatic Water (bacteriostatic water for injection) is sterile water containing 0.9% benzyl alcohol that is used to dilute or dissolve medications; the container can be reentered multiple times (usually by a sterile needle) and the benzyl alcohol suppresses or stops the growth of most potentially contaminating bacteria. The Bacteriostatic Water can be used in diluting drugs that can subsequently be administered by intravenous, intramuscular, or subcutaneous injection.
Bacteriostatic Water for Injection is supplied in a multiple-dose30 mL plastic containers and not pressurized. It is not used forneonatal medications because of possible blood pressurechanges and toxicity of benzyl alcohol. If Bacteriostatic Wateris injected intravenously without any diluted compound, itmay cause some red blood cell lysis because it is not isotonic.Bacteriostatic Water for Injection, USP must be madeapproximately isotonic prior to use.. Some side effects thatmay occur after drugs are added to Bacteriostatic Waterinclude fever, abscess formation, venous thrombosis orphlebitis, tissue necrosis, and infections.
B-Sterile Water for Injection, USP is asterile, nonpyrogenic preparation of water for injection whichcontains no bacteriostat, antimicrobial agent or added bufferand is supplied only insingle-dose containers to dilute or dissolve drugs for injection.For I.V. injection, add sufficient solute to make anapproximately isotonic solution.PH 5.0 to 7.0Precautions:Do not use unless water is clear, seal is intact and container isundamaged.
C-Sterile Water for IrrigationSterile Water for Irrigation is a sterile, distilled, nonpyrogenic waterfor injection intended only for sterile irrigation, washing, rinsing anddilution purposes. pH 5.5 (5.0 to 7.0).Sterile Water for Irrigation contains no bacteriostat, antimicrobialagent or added buffer and is intended for use only as a single-doseor short procedure irrigation. When smaller volumes are required theunused portion should be discarded.Sterile Water for Irrigation may be classified as a sterileirrigant, wash, rinse, diluent and pharmaceutical vehicle.NOT FOR INJECTION BY USUAL PARENTERAL ROUTESDo not heat container over 66 C (150 F).
D-Sterile Water for Inhalation is Water forInjection that is packaged and rendered sterile and is intendedfor use in inhalators and in the preparation of inhalationsolutions. It carries a less stringent specification for bacterialendotoxins than Sterile Water for Injection, and therefore, isnot suitable for parenteral applications.
E-Sterile purified water: Ispurified water that is packagedand rendered sterile, containsno antimicrobial agent.