A&C PRODUCT FOCUS: 2-PHENOXYETHANOL

A&C produces GMP Phenoxyethanol (excipient and API grade) that meets the most stringent Quality, Safety, Purity, and Suitability requirements for Pharmaceutical use.

What is Phenoxyethanol?
Phenoxyethanol, found naturally in green tea, is used as a vaccine preservative and also as an antibacterial API for pharmaceutical preparations. It is produced commercially as a synthetically derived, colourless, and mostly odourless, aromatic alcohol. It is highly valued in pharmaceutical applications due to its low toxicity whilst having excellent bactericidal and bacteriostatic properties. It is effective against a broad spectrum of gram-negative, and gram-positive bacteria, and to a less extent, against yeast and mold. Often it is combined with a second preservative (such as phenol, formaldehyde or benzethonium) to broaden its effectiveness against potential contaminants.
One of phenoxyethanol’s strengths is the inability of microorganisms to adapt to its presence, it remains effective. Typical use level in vaccines is approximately 5 mg/ml (0.5%). Phenoxyethanol is stable, non-reactive, and soluble in oil and water. It is recognized world-wide as an effective preservative and has monographs in the European, British and United Sates Pharmacopoeias.
Is there a problem with commercial grade Phenoxyethanol?
The majority of commercial phenoxyethanol is destined for use in cosmetics, perfumes, dyes, inks and various other personal care or industrial applications. These uses far exceed the quantities destined for Pharmaceutical use. This fact belies an age-old problem for our industry. Phenoxyethanol is a great product with useful activity and an excellent toxicity profile, however, most commercial grades are not manufactured with adequate GMPs for the Pharmaceutical market.
What do the regulators require?
The EU and Canada require excipient and API sources to have sufficient quality controls for fitness of purpose of the ingredient source to demonstrate equivalence to strict GMP. They may accept non-GMP sourcing (1) but the onus is placed with the drug manufacturer to take responsibility for and prove through time-consuming process and supply chain risk assessment, correction, approval and change-management that adequate quality controls are in place. The US FDA, on the other hand, notes that ICH Q7 applies to all APIs regardless of origin (2). With this in mind A&C decided to manufacture our own truly GMP phenoxyethanol that will satisfy even the US FDA’s strictest requirement for GMP compliance.

A&C manufactures two high purity GMP grades of Phenoxyethanol

A&C produces two grades using the same proprietary fractional process that yields a high purity phenoxyethanol with a superior impurity profile with all manufacturing 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 Ph. Eur. 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 Ph. Eur. compendia for phenoxyethanol
A current ASMF in standard CTD format is maintained in support of regulatory filings
A&C prides itself on strict controls, carries ISO and EXCi-PACT quality certifications, has a Drug Establishment license from Health Canada for manufacturing APIs and is audited by Health Canada and the US FDA.

If you use phenoxyethanol for a pharmaceutical application, we believe you should strongly consider our product for assurance it is designed from ‘start-to-finish’ to meet your GMP needs.

References:
(1) EMA: For example, the EMA states that when your ingredient source is not made to the GMP standard that an alternative suitable source should be sought. In “exceptional circumstances” the manufacturing authorisation holder should assess and document to which extent GMP is complied with and provide risk based justification for acceptance of any derogation. “The declaration provided by the Qualified Person should set out in detail the basis for declaring the standards applied provide the same level of assurance as GMP.”

QP Declaration Guidance:
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/06/WC500167852.pdf

Health Canada: Similarly, in exceptional cases Health Canada will accept non-GMP sources. Health Canada has a list of atypical APIs. Both phenol and benzethonium appear on the list but phenoxyethanol does not. https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/compliance-enforcement/notice-stakeholders-implementation-establishment-licensing-requirements-atypical-active-pharmaceutical-ingredients.html#aapil

(2) US FDA: In the presentation “An FDA Perspective on Atypical Active Ingredients” to the USP Stakeholders forum the FDA states “AA (Atypical Actives) fall under the same law, regulations, guidance, inspection program and standards (e.g. USP/NF) applicable to all API in all marketed drugs.” http://www.usp.org/sites/default/files/usp/document/get-involved/stakeholder-forums/3b-usp-stakeholder-forum-atypical-actives-wolfgang-fda.pdf

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