PHENOXYETHANOL

One of the products manufactured by A&C is GMP Phenoxyethanol. We produce 2-Phenoxyethanol in the form of excipient and API grade that always meets the most stringent quality, purity, suitability and safety requirements essential for the use of this product in the pharmaceutical industry

What is Phenoxyethanol ?

Phenoxyethanol can be used as a vaccine preservative, as well as an antibacterial active pharmaceutical ingredient (API) for pharmaceutical preparations. Its low toxicity and its excellent bactericidal and bacteriostatic properties make 2-Phenoxyethanol highly valued in pharmaceutical applications. It is effective against a broad spectrum of gram-negative, and gram-positive bacteria, and to a lesser extent, against yeast and mould. To broaden its effectiveness against potential contaminants, Phenoxyethanol is often combined with a second preservative (such as phenol, formaldehyde or benzethonium). Typical use level in vaccines is approximately 5 mg/ml (0.5%). Phenoxyethanol is non-reactive, stable, and soluble in water and oil. It is recognized worldwide as an effective preservative and has monographs in the European (EP), British (BP) and United States Pharmacopoeias (USP).
2-Phenoxyethanol is a valuable product with useful activity and an extraordinary low toxicity profile. However, most commercial grades are not manufactured with adequate GMPs for the Pharmaceutical market.

What do the regulators require?

When it comes to fitness of purpose of the ingredient source, both the European Union and Canada require excipients and API sources to have sufficient quality controls to demonstrate equivalence to strict GMP. Non-GMP sourcing may also be accepted, but it is the drug manufacturer’s responsibility to prove through time-consuming processes including supply chain risk assessment, correction, approval and change management that adequate quality controls are in place. The United States FDA, on the other hand, notes that ICH Q7 applies to all APIs regardless of origin. With this in mind, A&C decided to manufacture our own truly GMP Phenoxyethanol that satisfies even the US FDA’s strictest requirement for GMP compliance.

A&C’s Phenoxyethanol

A&C manufactures two high purity GMP grades of 2-Phenoxyethanol (excipient and API) using the same proprietary fractional process that yields a high purity Phenoxyethanol with a superior impurity profile while all manufacturing aspects are falling within suitable GMPs for pharmaceutical application.

– 2-Phenoxyethanol Multi-Compendial Excipient Grade

  • An excipient grade GMP-manufactured ingredient complying to IPEC GMP standard
  • Meets USP-NF and EP compendia for Phenoxyethanol
  • Truly GMP and GDP compliant start to finish, full supply chain transparency

– 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 prides itself on quality focus, strict controls and transparency in the supply chain. We hold ISO 9001:2015 and EXCiPACT quality certifications. We have a Drug Establishment License for manufacturing, labelling, testing and distribution of APIs issued by Health Canada. We are also audited by Health Canada and the US FDA. If your company utilizes 2-Phenoxyethanol for a pharmaceutical application, we strongly advise you to consider A&C’s Phenoxyethanol which is designed from ‘start-to-finish’ to meet your GMP need