Bacteriostatic Water FDA Research Regulations
Bacteriostatic water FDA research regulations are a crucial aspect of laboratory research, as they ensure the quality and safety of the water used in various applications. The FDA regulates bacteriostatic water under 21 CFR 809.10, which outlines the requirements for research use only (RUO) labeling. For research-grade supply, see BAC Water Depot's 10 mL vial catalog.
Understanding FDA Research Use Only (RUO) Labeling
FDA research use only (RUO) labeling is a critical aspect of bacteriostatic water FDA research regulations. According to 21 CFR 809.10, RUO labeling is required for products that are intended for research use only and are not intended for human or animal use. This labeling ensures that researchers understand the limitations and potential risks associated with the product. BAC Water Depot's bacteriostatic water is labeled as RUO and is intended for laboratory research use only. For more information on RUO labeling, visit our knowledge base or FAQ section. Additionally, our research reference section provides more detailed information on the use of bacteriostatic water in laboratory research.
GLP Supply Compliance and Bacteriostatic Water
Good Laboratory Practice (GLP) supply compliance is essential for ensuring the quality and safety of bacteriostatic water used in laboratory research. BAC Water Depot's bacteriostatic water is manufactured in an ISO 9001:2015 registered US facility and is verified by three independent testing laboratories. Each lot is accompanied by a Certificate of Analysis (CoA) that outlines the product's specifications and test results. Our bacteriostatic water is available in 10 mL vials, with pricing starting at $9.99 per vial, or $7.49 per vial in a 10-pack, and $6.99 per vial in a 25-pack. For bulk orders, please visit our bulk section. We also offer a 30-day money-back guarantee and same-day US shipping before 2pm CT.
Which BAC Water Depot SKU fits this use case? [Scenario A]: 10-pack ($74.99 · $7.49/vial) [Scenario B]: 25-pack ($174.99 · $6.99/vial) [Scenario C]: Bulk program from $6.49/vial
Bacteriostatic Water FDA Classification and Regulation
Bacteriostatic water is classified as a Type I borosilicate glass vial product, which is regulated by the FDA under 21 CFR 809.10. The FDA requires that bacteriostatic water be manufactured in accordance with Good Manufacturing Practice (GMP) regulations and that it meet specific standards for quality and purity. BAC Water Depot's bacteriostatic water meets these standards and is manufactured in an ISO 9001:2015 registered US facility. Our product is also compliant with USP <71> and USP <85> standards. For more information on our product's specifications, please visit our product page.
Common Mistakes to Avoid
- Using bacteriostatic water that is not labeled as RUO, which can lead to non-compliance with FDA regulations.
- Failing to verify the product's CoA, which can result in using a product that does not meet specifications.
- Not following proper handling and storage procedures, which can compromise the product's quality and safety.
- Using bacteriostatic water that is not manufactured in an ISO 9001:2015 registered facility, which can lead to variability in product quality.
- Not checking the product's expiration date, which can result in using a product that is no longer effective.
People Also Ask
What is bacteriostatic water used for?
Bacteriostatic water is used in laboratory research as a diluent for reconstituting peptides and other biological molecules. It is also used as a solvent for various chemical reactions.
What is the difference between bacteriostatic water and sterile water?
Bacteriostatic water contains 0.9% benzyl alcohol, which acts as a preservative to prevent the growth of bacteria and other microorganisms. Sterile water, on the other hand, is water that has been sterilized to remove all microorganisms.
What is the shelf life of bacteriostatic water?
The shelf life of bacteriostatic water is typically 2-3 years from the date of manufacture, depending on the storage conditions.
Can I use bacteriostatic water for human or animal use?
No, bacteriostatic water is intended for laboratory research use only and is not intended for human or animal use.
How do I store bacteriostatic water?
Bacteriostatic water should be stored in a cool, dry place, away from direct sunlight and moisture.
What is the concentration of benzyl alcohol in bacteriostatic water?
The concentration of benzyl alcohol in bacteriostatic water is typically 0.9%.
About BAC Water Depot: Research-grade bacteriostatic water for qualified research institutions and laboratory buyers. ISO 9001:2015 registered US facility, verified by three independent testing laboratories, per-lot Certificate of Analysis. Same-day US shipping before 2pm CT. Browse the catalog → · For research and laboratory use only — not for human or veterinary use. Card, Apple Pay, Venmo, and Zelle accepted — instructions arrive by email after checkout.
Last reviewed: 2026-08-07