“USP” means the product complies with the monograph for bacteriostatic water published in the United States Pharmacopeia. The USP is a compendium of public quality standards; a monograph is the standard for one specific article, setting out its definition, the tests it must pass and the limits it must meet. When a manufacturer puts “USP” after the product name, it is stating that the lot meets that monograph.
What the monograph requires
- The product is sterile WFI-grade water containing one or more suitable antimicrobial agents, packaged in single-use or multi-use containers not larger than 30 mL.
- The label states the name and proportion of the antimicrobial agent, which is why every vial reads “0.9% benzyl alcohol”.
- Tests and limits: sterility (USP <71>), bacterial endotoxins (USP <85>, not more than 0.5 EU/mL), pH between 4.5 and 7.0, particulate matter (USP <788>), and the general requirements for packaging and labeling.
See USP water grades explained for how this monograph relates to Purified Water, WFI-grade water and Sterile Water.
Who writes it
The United States Pharmacopeial Convention is an independent, non-governmental standards organization. Its standards are recognized in United States law, and manufacturers are inspected against them by the regulator. The monograph is revised from time to time; the current edition is the one that applies.
What the letters do not tell you
- They do not identify the manufacturer or the site of manufacture; the label and the certificate of analysis do that.
- They do not say anything about how the vial was stored or handled after it left the manufacturer, which is the buyer’s responsibility. See how bacteriostatic water is shipped.
- They are a statement of compliance, not a test result. The results for the specific lot are on the certificate of analysis. See how to read a COA.
Related
What is bacteriostatic water? · Real vs. substandard bacteriostatic water
All BAC Water Supply products are supplied for laboratory research use only and are not for human or veterinary use.