"As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities"...
BACTERIOSTATIC WATER (bacteriostatic water (bacteriostatic water for injection) for injection)
for Injection, USP
Multiple-dose Plastic Vial
The following 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.
Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. The pH is 5.7 (4.5 to 7.0).
Water for Injection, USP is chemically designated H2O.
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 labeled volume.
Last reviewed on RxList: 1/26/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Bacteriostatic Water Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Weight Loss Wisdom
Get tips, recipes and inspiration.