Phenoxyethanol: Uses, Safety, and Benefits

PHENOXYETHANOL

The product GMP Phenoxyethanol is one that A&C produces. We manufacture 2-phenoxyethanol in excipient and API grade forms, and we consistently meet the strictest quality, purity, appropriateness, and safety standards necessary for this product to be used in the pharmaceutical business.

What is Phenoxyethanol ?

Phenoxyethanol is an antibacterial active pharmaceutical ingredient (API) for pharmaceutical formulations and can also be used as a preservative for vaccines. 2-Phenoxyethanol is widely appreciated in pharmaceutical applications because of its outstanding bactericidal and bacteriostatic characteristics, as well as its low toxicity. It works well against a wide range of bacteria, both gram-positive and gram-negative, and to a lesser degree, against mold and yeast. In order to enhance its efficacy against possible impurities, phenoloxyethanol is frequently mixed with another preservative (such phenol, formaldehyde, or benzethonium). Vaccines typically have a use level of 5 mg/ml (0.5%). Phenoxyethanol is stable, soluble in both water and oil, and non-reactive. It is a widely accepted effective preservative with monographs in the United States, British, and European Pharmacopoeias (USP), as well as an EP and BP.
2. Phenoxyethanol is an important product with useful activity and an extraordinary low toxicity profile. However, most commercial grades are not manufactured with adequate GMPs for the Pharmaceutical market.

Why do the regulators require?

Both the European Union and Canada require excipients and API suppliers to have adequate quality controls to establish equivalency to rigorous GMP when it comes to the ingredient source’s fitness for purpose. Non-GMP sourcing may also be permitted, but it is the duty of the pharmaceutical producer to demonstrate that sufficient quality controls are in place through laborious procedures including supply chain risk assessment, correction, approval, and change management. On the other side, the US FDA states that ICH Q7 is applicable to all APIs, regardless of place of origin. In light of this, A&C made the decision to produce our own fully GMP phenoloxyethanol, which meets even the most stringent GMP compliance requirements set by the US FDA.

A&C’s Phenoxyethanol

Using the same patented fractional method, A&C produces two high purity GMP grades of 2-Phenoxyethanol (excipient and API) with superior impurity profiles and all manufacturing processes that meet appropriate GMPs for use in pharmaceutical applications.

2-Phenoxyethanol Multi-Compendial Excipient Grade

2-Phenoxyethanol Multi-Compendial API Grade

An API grade ingredient that meets the ICH Q7 GMP standard
This grade has an EDQM CEP certificate of suitability available to interested drug manufacturers. The CEP is officially recognized throughout Europe, the USA, Canada and many other international markets
Meets USP-NF and EP compendia for Phenoxyethanol
A current ASMF in standard CTD format is maintained in support of regulatory filings

A&C takes great pride in its attention to quality, stringent regulations, and supply chain transparency. We are certified to both EXCiPACT and ISO 9001:2015* quality standards. Health Canada has granted us a Drug Establishment License so that we can manufacture, label, test, and distribute APIs. The US FDA and Health Canada both audit us as well. We strongly suggest that, if your organization uses 2-Phenoxyethanol for a pharmaceutical application, you take into account A&C’s Phenoxyethanol, which is made to meet your GMP requirements from the ground up.