Sterile Bacteriostatic Water (0.9% Benzyl Alcohol)

Product Overview

The Sterile Bacteriostatic Water (0.9% Benzyl Alcohol) is a high-purity, laboratory-grade reagent specifically engineered for applications demanding stringent aseptic conditions and repeated access. Formulated with 0.9% Benzyl Alcohol as a preservative, this product is the superior choice for high-throughput laboratory environments where the integrity of multi-use reagent stocks and calibration fluids is paramount.

Product Profile

Item: Sterile Bacteriostatic Water (0.9% Benzyl Alcohol)

Grade: Laboratory Reagent

Key Benefit: Allows for convenient, repeated needle withdrawals from the same container while preserving assay reliability and sample integrity.

Description: Designed for high-throughput laboratory environments, this bacteriostatic water ensures aseptic conditions are maintained across multi-use applications. The inclusion of 0.9% benzyl alcohol prevents bacterial growth, making it the superior choice for preparing reagent stocks and calibration fluids that require frequent access.

Technical Specifications

Parameter

Specification

Unit of Measure

Test Method

Formulation

Water for Injection (WFI)

N/A

USP/EP Monograph

Preservative

Benzyl Alcohol (BnOH)

0.9% (w/v)

HPLC

Sterility

Sterile

N/A

USP <71> Sterility Tests

Endotoxin Level

< 0.25

Endotoxin Units (EU)/mL

LAL Test (USP <85>)

pH Range

5.0 - 7.0

N/A

USP <791> pH

Osmolality

250 - 300

mOsm/kg

USP <785> Osmolality

Applications

This bacteriostatic water is essential for a variety of laboratory applications, including:

• Reagent Preparation: Used as a diluent for preparing stock solutions and working solutions of various reagents, including lyophilized peptides, proteins, and molecular components.
• Calibration Fluid Dilution: Ideal for diluting standards and controls in analytical instruments, such as HPLC, GC, and mass spectrometry, where microbial contamination can interfere with results.
• Cell Culture Media Preparation: While not a primary component, it can be used for non-direct cell contact applications, such as cleaning or equipment preparation, where a preserved, sterile water source is needed.
• General Laboratory Use: Suitable for rinsing, washing, and preparing equipment that requires a sterile, non-pyrogenic solvent.

Quality Assurance

Sterility and Aseptic Handling

This product is manufactured under strict cGMP guidelines and terminally sterilized to ensure the highest level of sterility. The 0.9% Benzyl Alcohol acts as a reliable preservative, inhibiting the growth of most common bacteria encountered during repeated access with a sterile needle.

Stability and Storage

The product maintains its stability and efficacy when stored under recommended conditions.

• Storage Temperature: Store at 2°C to 25°C (36°F to 77°F).
• Handling: After initial puncture, it is recommended that the product be used within 28 days to maintain efficacy, though the Benzyl Alcohol preservative extends the utility beyond that of non-preserved sterile water.
• Shelf Life: Refer to the expiration date printed on the product label.

Ordering Information

For pricing, current lead times, and bulk order options, please contact Person at Person@email.com or call Person.

Product Name

Volume

Item Code

Packaging

Sterile Bacteriostatic Water (0.9% BnOH)

10 mL

BSW-010

Single-use vial

Sterile Bacteriostatic Water (0.9% BnOH)

30 mL

BSW-030

Multi-dose vial

Sterile Bacteriostatic Water (0.9% BnOH)

50 mL

BSW-050

Multi-dose vial

Safety Data Sheet (SDS)

The Safety Data Sheet for Sterile Bacteriostatic Water (0.9% Benzyl Alcohol) can be accessed by clicking the following link: File

Compatibility and Usage Notes

• Compatibility: Generally compatible with most laboratory chemicals and biological materials. However, users should verify compatibility when used as a diluent for sensitive assays.
• Route of Administration: This product is strictly for Laboratory Reagent use only and is NOT for human or animal use (injection or consumption).
• Disposal: Dispose of unused contents and containers in accordance with local, state, and federal regulations.

Frequently Asked Questions (FAQ)

What is the function of 0.9% Benzyl Alcohol in the water?

The Benzyl Alcohol serves as a bacteriostatic agent, which means it inhibits the growth of bacteria. This is crucial for multi-dose applications where the vial is punctured multiple times over a period, allowing the contents to remain sterile and free from microbial contamination.

Is this product non-pyrogenic?

Yes, this product is manufactured to be non-pyrogenic, with endotoxin levels strictly controlled to be less than 0.25 EU/mL, making it suitable for applications that are sensitive to pyrogens.

How does the preservation affect the shelf life after initial puncture?

While standard sterile water without a preservative must be discarded shortly after first use (often within 24 hours), the inclusion of 0.9% Benzyl Alcohol typically extends the allowed use-period to up to 28 days following the first needle puncture, provided proper aseptic technique is maintained.

Where can I find the Certificate of Analysis (CoA)?

The Certificate of Analysis for a specific lot number can be requested via email to our Quality Control department or downloaded from our portal: File.

Research and Development

Our commitment to providing high-quality laboratory reagents includes continuous R&D to improve purity and usability. We welcome feedback from researchers and clinicians on their specific needs and applications.

For research inquiries or collaboration, please contact the R&D team at Person.

Usage Protocol Summary

The following table outlines a standard protocol for the use of Sterile Bacteriostatic Water in a typical laboratory setting:

Step

Action

Purpose

Aseptic Consideration

1

Visually inspect the vial

Ensure the seal is intact and the solution is clear

Verify product integrity before use

2

Wipe the septum

Clean the rubber stopper with an alcohol swab

Minimize contamination upon needle entry

3

Withdraw required volume

Use a new, sterile needle and syringe

Maintain sterility of remaining contents

4

Dilute/Reconstitute

Introduce the water into the target material

Prepare solution for assay/application

5

Label the vial

Mark with date of first use and initials

Track open date for 28-day compliance

Manufacturing and Certification

The Sterile Bacteriostatic Water (0.9% Benzyl Alcohol) is produced in a state-of-the-art facility located in Place, which adheres to ISO 13485 standards for medical device and reagent quality management.

We ensure that every batch undergoes rigorous testing, including:

• Bioburden Testing: To confirm low levels of microbial contamination before sterilization.
• Pyrogen Testing (LAL): To confirm non-pyrogenicity.
• Preservative Efficacy Testing (PET): To validate the effectiveness of the 0.9% Benzyl Alcohol over the multi-use period.

Documentation and Resources

Access the following documents for comprehensive information:

• Product Insert and Instructions for Use: File
• Batch-Specific Certificate of Analysis Portal: File
• Regulatory Compliance Statement: File

For technical support or detailed questions regarding product specifications, please schedule a consultation with our experts via this link: Calendar event.