Benzyl Alcohol 0.9% (Bacteriostatic Reagent)

Chemical Profile Overview

The Benzyl Alcohol 0.9% Solution serves as a crucial bacteriostatic diluent, ensuring the stability and shelf-life of reconstituted reagents and sensitive biochemical products. Its primary function is to inhibit the growth of most bacteria in multi-dose vials, making it an essential vehicle in laboratory settings.

Property

Value

Product Name

Benzyl Alcohol 0.9% Solution

Formula

C₆H₅CH₂OH (0.9% v/v) in H₂O

Function

Bacteriostatic Diluent / Vehicle

Sterility

Sterile Filtered / Non-Pyrogenic

Section 2: Detailed Chemical Analysis

This section details the analytical data verifying the composition and purity of the Benzyl Alcohol 0.9% solution. All analyses were conducted using validated, calibrated instrumentation.

Analytical Verification (Batch 2025007)

The following data confirms the specifications of the current production batch, Batch 2025007.

Parameter

Instrument/Method

Result

Instrument

LCMS-7800 Series

Calibrated

Primary Retention Time

HPLC

3.48 min

Purity

HPLC confirmation

99.42%

Mass Spectrometry

LCMS

711.9 Da (Observed)

Impurity Profile

Trace secondary peak

Restricted to 0.58%

Mechanism of Action

Benzyl Alcohol functions by disrupting the structure of bacterial cell membranes, which interferes with nutrient uptake and metabolic processes, thus preventing bacterial proliferation in the solution. This bacteriostatic effect is achieved effectively at the 0.9% concentration, providing preservation without compromising the integrity of most active pharmaceutical ingredients (APIs).

Section 3: Reagent Handling and Storage Protocols

Proper handling and storage are critical to maintaining the sterility and efficacy of the Benzyl Alcohol 0.9% Solution.

Handling Instructions

• Storage (Unopened): Store at ambient laboratory temperature, protected from direct sunlight.
• Usage: This solution is primarily used for preparing reusable reagent vials, extending the usable life of the contents.
• Aseptic Technique: Always use sterile syringes and needles when withdrawing or adding solution to maintain the non-pyrogenic status of the product.

Post-Reconstitution Guidelines

When the Benzyl Alcohol 0.9% solution is used as a vehicle for sensitive compounds, such as peptides, specific storage conditions apply:

Compound Type

Post-Reconstitution Storage

Shelf Life Indication

Peptides

2-8°C (Refrigerated)

Refer to specific peptide stability data

Small Molecules

Ambient or Refrigerated

Compound-dependent

Antibodies

2-8°C (Refrigerated)

Maximize stability

Section 4: Safety, Regulatory Compliance, and Quality Assurance

Safety and Precautionary Measures

While Benzyl Alcohol is generally safe as a bacteriostatic agent at this concentration, standard laboratory precautions must be followed:

• Eye Contact: Flush immediately with plenty of water for at least 15 minutes. Seek medical attention if irritation persists.
• Skin Contact: Wash exposed area thoroughly with soap and water.
• Ingestion: Do not induce vomiting. Seek immediate medical attention.

Regulatory Compliance

The Benzyl Alcohol 0.9% solution is manufactured under strict adherence to Good Manufacturing Practices (GMP) and is certified as Non-Pyrogenic. The sterility is achieved via a 0.2-micron sterile filtration process. Detailed compliance records and the Certificate of Analysis (CoA) for Batch 2025007 are available in the associated quality file: File.

Section 5: Applications and Benefits

The use of Benzyl Alcohol 0.9% offers significant advantages in biological and chemical laboratories.

Primary Applications

• Reconstitution of Lyophilized Peptides and Proteins: Provides a preservative for multi-dose applications, reducing contamination risk.
• Sterile Dilution: Serves as a sterile, non-reactive solvent for many water-soluble compounds.
• General Bacteriostatic Vehicle: Ideal for maintaining the sterility of reagents stored for moderate periods.

Benefits

1. Extended Shelf Life: Significantly prolongs the usability of reconstituted solutions.
2. Safety Profile: Used at a safe, non-toxic concentration for general laboratory work.
3. Low Volatility: Stable composition ensures consistent concentration during storage.

For inquiries regarding batch-specific data or technical specifications, please contact Person via email.

Section 6: Standard Operating Procedure (SOP) for Reconstitution

This SOP provides a step-by-step guide for using the Benzyl Alcohol 0.9% Solution to reconstitute lyophilized powders.

Materials Required

• Lyophilized compound vial
• Benzyl Alcohol 0.9% Solution
• Sterile syringe and needle
• Alcohol swabs

Procedure Steps

Step

Action

Key Consideration

1

Prepare the Vials

Clean the rubber stopper of both the compound vial and the Benzyl Alcohol vial with an alcohol swab.

2

Determine Volume

Calculate the exact volume of Benzyl Alcohol needed to achieve the desired concentration.

3

Withdraw Solvent

Slowly draw the required volume of Benzyl Alcohol 0.9% into the sterile syringe.

4

Inject Solvent

Inject the Benzyl Alcohol into the lyophilized compound vial, aiming the needle tip against the side of the glass to prevent foaming.

5

Mix the Solution

Gently swirl the vial to dissolve the powder. DO NOT SHAKE vigorously.

6

Storage

Store the reconstituted solution according to the Post-Reconstitution Guidelines (Section 3).

The next review of this SOP is scheduled for Date.Section 7: Waste Disposal and Environmental Impact

Proper disposal of the Benzyl Alcohol 0.9% Solution and any associated contaminated materials is essential for laboratory safety and environmental protection.

Waste Disposal Procedures

Category

Procedure

Key Consideration

Unused Solution

Collect in a designated solvent waste container.

Ensure compatibility with other waste streams; label clearly as Hazardous Waste - Flammable Liquid (though low flash point at 0.9%).

Contaminated Vials/Syringes

Place in a sharps container or designated biohazard waste container after autoclaving, if necessary.

Follow institution-specific protocols for biohazard or medical waste disposal.

Spills

Absorb small spills with inert material (e.g., vermiculite, sand). For large spills, consult the emergency response team.

Ventilate the area; dispose of absorbent material as hazardous waste.

Environmental Impact Notes

Benzyl Alcohol is generally biodegradable. However, due to its preservative nature, it should not be disposed of directly down the drain. Always adhere to local, state, and federal regulations regarding the disposal of laboratory chemicals. The low concentration (0.9%) minimizes environmental risk compared to concentrated forms, but responsible disposal practices must be maintained.