Benzyl Alcohol
Benzyl Alcohol is known as an antimicrobial preservative, disinfectant, solvent. Benzyl Alcohol  is one of the ingredients in Arvin Kala’s diverse product portfolio.
Description
A transparent, colorless, and oily liquid that has a mild aromatic scent and a sharp, pungent taste. The structural form of Benzyl Alcohol is as follows:
Applications in Pharmaceutical Formulation
Benzyl alcohol serves as an antimicrobial preservative in cosmetics, foods, and various pharmaceutical formulations, including both oral and parenteral preparations, at concentrations up to 2.0% v/v. Typically, it is used at a concentration of 1% v/v. Its application has been noted in protein, peptide, and small molecule products, although its usage has declined from 48 products in 1996 to 30 in 2001, and further down to 15 in 2006. In cosmetics, concentrations up to 3.0% v/v of benzyl alcohol can be used as a preservative. When used as a solubilizer, concentrations of 5% v/v or higher are employed. Additionally, a 10% v/v solution is utilized as a disinfectant.
Benzyl alcohol solutions at 10% v/v also possess local anesthetic properties, which are utilized in certain parenteral medications, cough products, ophthalmic solutions, ointments, and dermatological aerosol sprays.
Stability and Storage Conditions
Benzyl alcohol gradually oxidizes in air to form benzaldehyde and benzoic acid, but it does not react with water. Aqueous solutions can be sterilized by filtration or autoclaving, though some solutions may produce benzaldehyde during autoclaving.
Benzyl alcohol should be stored in metal or glass containers, as plastic containers are generally unsuitable. Exceptions include polypropylene containers or vessels coated with inert fluorinated polymers like Teflon.
Benzyl alcohol should be stored in an airtight container, shielded from light, and kept in a cool, dry place.
Method of Manufacture
Benzyl alcohol is commercially produced by distilling benzyl chloride with potassium or sodium carbonate. It can also be synthesized through the Cannizzaro reaction, which involves benzaldehyde and potassium hydroxide.
Safety
Benzyl alcohol is utilized in a wide range of pharmaceutical formulations. It is metabolized into benzoic acid, which is then further processed in the liver by conjugation with glycine to form hippuric acid, which is subsequently excreted in the urine.
Ingesting or inhaling benzyl alcohol can lead to headaches, vertigo, nausea, vomiting, and diarrhea. Overexposure may cause central nervous system depression and respiratory failure. However, the concentrations of benzyl alcohol typically used as a preservative do not usually cause these adverse effects.
Adverse reactions to benzyl alcohol used as an excipient have been reported, including toxicity following intravenous administration, neurotoxicity in patients receiving intrathecal preparations, and hypersensitivity, although this is relatively rare. Additionally, a fatal toxic syndrome has been observed in premature infants.
The fatal toxic syndrome in low-birth-weight neonates, characterized by symptoms of metabolic acidosis and respiratory depression, has been linked to the use of benzyl alcohol as a preservative in solutions for flushing umbilical catheters. Consequently, the FDA has recommended against using benzyl alcohol in such flushing solutions and has advised against the use of medicines containing preservatives in newborns.
The WHO has established that the estimated acceptable daily intake of the benzyl/benzoic moiety is up to 5 mg per kilogram of body weight per day.
Handling Precautions
Take standard precautions based on the circumstances and the amount of material being handled. Benzyl alcohol, in both liquid and vapor forms, can irritate the skin, eyes, and mucous membranes. It is advisable to use eye protection, gloves, and protective clothing. Ensure that benzyl alcohol is handled in a well-ventilated area; in poorly ventilated spaces, a self-contained breathing apparatus is recommended. Additionally, benzyl alcohol is flammable.
Chemical-physical values
| Test Item | Unit | Specification |
|---|---|---|
|
DESCRIPTION |
|
Clear Colourless Oily Liquid Boils at about 206°C withoutdecomposition and is neutral to litmus |
|
Benzyl Alcohol Impurity A (Benzaldehyde) |
% |
NMT. 0.05 |
|
Benzyl Alcohol impurity (Cyclohexyl methanol) |
% |
NMT. 0.10 |
|
Sum of allother secondary Peaks (RRT Less than) Benzyl Alcohol |
% |
NMT. 0.020 |
|
Sum of allother secondary Peaks (RRT more than) Benzyl Alcohol |
% |
NMT. 0.20 |
| Test Item | Unit | Specification |
|---|---|---|
|
Residue on Evaporation |
% |
NMT. 0.05 |
|
Bacterial Endotoxin Test |
IU/ML |
LESS THAN 2.5 |
|
Total Aerobic Microbial count |
cfu per ml |
NMT 100 |
|
Total Combined Yeast and Mold Count |
cfu per ml |
NMT 10 |
|
REFRACTIVE INDEX |
|
NLT 1.538 NMT 1.541 |
|
WEIGHT PER ML |
|
NLT 1.043 NMT 1.049 |
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