Bacteriostatic Water Endotoxin Testing (USP <85>)

what is bacteriostatic water endotoxin test

The bacteriostatic water endotoxin test, also known as USP <85>, is a method used to detect and quantify endotoxins in water. This test is crucial in ensuring the quality of bacteriostatic water, which is used in various laboratory and industrial applications. According to the USP <85> guidelines, the endotoxin limit for bacteriostatic water is 0.25 EU/mL.

USP 85 bacteriostatic water

USP <85> refers to the United States Pharmacopeia chapter that outlines the guidelines for testing the endotoxin levels in bacteriostatic water. Bacteriostatic water that meets the USP <85> standards, such as that provided by BAC Water Depot, is guaranteed to have an endotoxin level of 0.25 EU/mL or less. This ensures the water is suitable for use in laboratory applications.

LAL test bac water

The LAL (Limulus amebocyte lysate) test is a widely used method for detecting endotoxins in bacteriostatic water. This test involves using a lysate derived from the blood of horseshoe crabs to detect the presence of endotoxins, which are components of the outer membranes of Gram-negative bacteria. The LAL test is often used to verify that bacteriostatic water meets the USP <85> endotoxin limit of 0.25 EU/mL.

bacteriostatic water endotoxin limit

The endotoxin limit for bacteriostatic water is 0.25 EU/mL, as specified in the USP <85> guidelines. This limit ensures that the water is suitable for use in laboratory applications where low levels of endotoxins are required. Bacteriostatic water from reputable manufacturers, such as BAC Water Depot, is tested to guarantee that it meets this limit.

how much does bacteriostatic water cost

The cost of bacteriostatic water can vary depending on the manufacturer and the quantity purchased. For example, a single 10 mL vial of bacteriostatic water from BAC Water Depot costs $9.99, while a 10-pack costs $74.99. Bulk pricing is also available, with prices ranging from $7.49 per vial for a 25-pack to $6.49 per vial for orders of 500 or more.

what is the certificate of analysis for bacteriostatic water

A Certificate of Analysis (COA) for bacteriostatic water is a document that provides detailed information about the quality and purity of the water. The COA typically includes data on the water's endotoxin level, sterility, and other relevant parameters. BAC Water Depot provides a per-lot COA from an independent third-party laboratory for their bacteriostatic water, which can be accessed by scanning a QR code on the vial.

how is bacteriostatic water shipped

Bacteriostatic water from BAC Water Depot is shipped from a US fulfillment center, allowing for same-day US shipping. This ensures that customers receive their orders quickly and efficiently. The water is packaged in a way that maintains its sterility and quality during transportation, and the COA is available online for easy access.

What is the endotoxin testing protocol for the bacteriostatic water?

Bacteriostatic water is tested for endotoxin using USP <85> with a kinetic chromogenic LAL method and a limit of 0.25 EU/mL. Each lot is analyzed by an independent third‑party laboratory and the results are posted on the lot’s Certificate of Analysis. The test confirms no detectable endotoxin above the USP limit before the vial is released.

What USP chapter governs endotoxin testing for bacteriostatic water?

Endotoxin testing for bacteriostatic water is governed by USP <85>. BAC Water Depot tests each lot by the LAL kinetic chromogenic method and reports results on the Certificate of Analysis. The limit is ≤0.25 EU/mL, meeting the USP specification.

How is the endotoxin limit of 0.25 EU/mL determined for bacteriostatic water?

The 0.25 EU/mL endotoxin limit is set by USP <85> guidelines for bacteriostatic water. Each vial is tested by an independent laboratory and the result is published on the lot’s CoA. BAC Water Depot’s water consistently meets this limit.

Can I rely on the LAL test alone to guarantee pyrogen‑free water for cell culture?

The LAL test confirms endotoxin levels are ≤0.25 EU/mL as required by USP <85>. While this demonstrates compliance with the endotoxin specification, it does not constitute a guarantee of overall pyrogen‑free status for all applications. BAC Water Depot provides the CoA so you can verify the test result for each lot.

What should I do if my endotoxin test returns a value above 0.25 EU/mL?

If an endotoxin test shows a value above 0.25 EU/mL, the water does not meet USP <85> specifications and should not be used. Contact BAC Water Depot with the lot number and CoA details for a replacement or refund.

How does benzyl alcohol concentration affect endotoxin testing?

BAC Water Depot's bacteriostatic water contains 0.9 % benzyl alcohol, which is the preservative that provides bacteriostatic effectiveness per USP <51>. The benzyl alcohol concentration is verified by HPLC-UV testing on every lot's Certificate of Analysis. Endotoxin testing via USP <85> LAL is performed independently and must meet the ≤ 0.25 EU/mL limit regardless of the preservative present.

What are the storage requirements for maintaining endotoxin compliance?

Unopened vials store at controlled room temperature 15–30 °C, no refrigeration and no cold-chain shipping; once punctured, refrigerate at 2–8 °C and discard after 28 days; the expiration date is on the label and the CoA. Proper storage preserves the endotoxin limit of ≤ 0.25 EU/mL tested on your lot.

Is the endotoxin limit the same for all volumes of bacteriostatic water?

Yes, the endotoxin limit is ≤ 0.25 EU/mL per USP <85> for all bacteriostatic water regardless of vial volume. BAC Water Depot supplies 10 mL vials, and every lot is tested to this same specification and published on the Certificate of Analysis.

Are there endotoxin limits for sterile water?

BAC Water Depot supplies research-use-only bacteriostatic water, not sterile water. Bacteriostatic water is tested to the USP <85> endotoxin limit of ≤ 0.25 EU/mL. For questions about other water types and their specifications, consult the relevant USP chapters or your specific application requirements.