Human Use & API

Hydrogen Peroxide as an Active Pharmaceutical Ingredient (API)

Hydrogen peroxide is used in medicine and oral hygiene as a disinfectant to combat pathogens on the skin and in wounds, helping to prevent infectious diseases. It also supports the prevention of inflammation in the oral and pharyngeal regions.

Hydrogen peroxide is found in the human body and serves the immune defense. After an injury, the body releases hydrogen peroxide for the body's own wound healing to fight pathogens itself. Our H₂O₂ products in low concentrations are virtually predestined for use on humans, i.e. the cleaning and disinfection of wounds, but also of medical instruments and devices that come into direct contact with the body.

Regulatory Compliance for API-Grade Hydrogen Peroxide

According to EU Directive 62/2011/EU on the community code relating to medicinal products for human use, it is mandatory for all producers of active substances used for medicinal products to be registered at the appropriate authorities of the country of origin to prevent the entry of falsified medicinal products into the legal supply chain. Precondition for this registration is the approval of the production of the active ingredient according to Good Manufacturing Practice (GMP) guidelines.

We offer a special hydrogen peroxide grade with the brand name PERSYNT® GMP which is manufactured under GMP conditions to meet the requirements of this regulation when using hydrogen peroxide as an active pharmaceutical ingredient. The product is also listed in EudraGMDP, a database for GMP certified manufacturers.

Furthermore, Evonik is also holder of a Certificate of suitability to monographs of the European Pharmacopoeia, CEP, for its product PERSYNT 300 GMP. The CEP significantly eases the management of new applications and maintenance of existing Marketing Authorizations (MA) for medicinal products. Clicke here to view the Evonik certificate (RO-CEP-2018-079) in EDQM´s database.

Applications of Hydrogen Peroxide in Human Use

Oral Hygiene

Hydrogen peroxide is not only used for teeth whitening, but also for disinfecting the oral cavity and throat due to its antiseptic properties, which help prevent inflammation. Additionally, dental professionals employ H₂O₂ to control bleeding during treatment procedures.

Hydrogen peroxide is used as an excipient in other medicinal products

Excipient Use

Hydrogen peroxide is used as an excipient in pharmaceutical formulations, for example as a preservative or in the synthesis of active ingredients. Our GMP-grade H₂O₂ supports compliance with strict quality standards in these applications.

Doctor putting bandage on injured hand of patient

Wound Cleaning and Disinfection

Low-concentration hydrogen peroxide solutions are used for wound care, where the release of oxygen helps eliminate bacteria, cleanse the area, and disinfect the wound—thereby reducing the risk of infection.

Our Product Brand

PERSYNT®

Evonik's versatile hydrogen peroxide PERSYNT® is specialized for use in cosmetics, personal care, and other high-purity applications such as human use, cleaning in place, food processing and chemical synthesis.

Key Benefits of PERSYNT®

Broadest GMP scope, covering the entire hydrogen peroxide production process, not just filling and labelling
CEP available for easy market authorization applications
Any supporting documentation provided on request (e.g., Nitrosamine statement)

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