Pharmaceutical water

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Pharmaceutical water

  1. 1. Pharmaceutical Water CompendialTypes 1.Bulk forms which are typically produced on site where they are used. A-Purified Water (PW) B-Water for Injection (WFI) 2.Packaged Forms which are produced, packaged, and sterilized to preserve microbial quality throughout their packaged shelf life. A-BacteriostaticWFI B-Sterile Water for Inhalation C-Sterile Water for Injection D-Sterile Water for Irrigation E-Sterile purified water
  2. 2. 1-Bulk forms A-Purified water: (USP), is used in the preparation of some bulk pharmaceutical chemicals, do not use purified water in preparations intended for parenteral administration. Must be protected from microbial proliferation.
  3. 3. B-Water for injection,USP: conforms with the standards of purified water,USP but is also pyrogen-free. Intended to be used in the manufacture of injectable products which are to be sterilized after their preparation. Intended to be used for 24-hours after its collection. It must be protected from microbial contamination.
  4. 4. 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.
  5. 5. Bacteriostatic Water for Injection is supplied in a multiple-dose 30 mL plastic containers and not pressurized. It is not used for neonatal medications because of possible blood pressure changes and toxicity of benzyl alcohol. If Bacteriostatic Water is injected intravenously without any diluted compound, it may cause some red blood cell lysis because it is not isotonic. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use.. Some side effects that may occur after drugs are added to Bacteriostatic Water include fever, abscess formation, venous thrombosis or phlebitis, tissue necrosis, and infections.
  6. 6. B-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.PH 5.0 to 7.0 Precautions: Do not use unless water is clear, seal is intact and container is undamaged.
  7. 7. C-Sterile Water for Irrigation Sterile Water for Irrigation is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Sterile Water for Irrigation may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES Do not heat container over 66 C (150 F).
  8. 8. D-Sterile Water for Inhalation is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solutions. It carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection, and therefore, is not suitable for parenteral applications.
  9. 9. E-Sterile purified water: Is purified water that is packaged and rendered sterile, contains no antimicrobial agent.

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