A&C produces GMP Phenyl Ethyl Alcohol Multi-Compendial that meets the most stringent Quality, Safety, Purity, and Suitability requirements for Pharmaceutical use.
What is Phenyl Ethyl Alcohol?
Phenyl Ethyl Alcohol (also known as phenethyl alcohol or 2-phenylethanol) is a colorless, aromatic, and somewhat viscous liquid fragrance found naturally in many essential oils in nature such as rose, carnation, hyacinth and many others. It is used widely in cosmetics, perfumes and pharmaceuticals due to its low toxicity, beautiful fragrance and its antibacterial properties. It is produced commercially as a synthetically derived, colorless compound via a Friedel Crafts reaction from benzene and ethylene oxide. It is known as the rose fragrance.
Is there a problem with commercial grade Phenyl Ethyl Alcohol?
The majority of commercial Phenyl Ethyl Alcohol is destined for use in cosmetics, perfumes, or as a flavor. These uses far exceed the quantities destined for pharmaceutical use, where Phenyl Ethyl Alcohol is utilized because of its useful activity and its excellent toxicity profile. However, most commercial grades are not manufactured with adequate GMPs for the pharmaceutical market. Indeed, it has been our experience (from auditing our supply network) that even GMP sources may involve down-packing or other steps in the supply chain that do not meet our expectations for excipient GMPs required by the pharmaceutical industry.
A&C manufactures two high purity GMP grades of Phenyl Ethyl Alcohol
A&C produces two grades of this product using the same proprietary fractional process that yields a high purity Phenyl Ethyl Alcohol, with a superior impurity profile (very low aldehydes and chlorinated compounds) and with all manufacturing falling within suitable GMPs for pharmaceutical application.
• Phenyl Ethyl Alcohol USP
o An excipient grade GMP manufactured ingredient complying to IPEC GMP standard
o Meets USP-NF monograph (has ultra-low residue on ignition)
o Truly GMP and GDP compliant start to finish, full supply chain transparency
• Phenyl Ethyl Alcohol Multi-Compendial
o An excipient grade ingredient
o Meets USP-NF and JP compendia
o EXCiPACT GMP and GDP certified manufacturing
A&C prides itself on strict controls, holds ISO 9001:2015 and EXCiPACT quality certifications, has a Drug Establishment license from Health Canada for manufacturing of APIs and is audited by Health Canada and the US FDA.
If your company utilizes Phenyl Ethyl Alcohol for a pharmaceutical application, we believe you should strongly consider A&C’s product for assurance it is designed from ‘start-to-finish’ to meet your GMP requirements.