Hydrogen Peroxide 35% - PHARMACEUTICAL GRADE

Pharmaceutical-grade Hydrogen Peroxide is a highly stabilized hydrogen peroxide solution manufactured in accordance with GMP requirements.

STABILITY AND PURITY

- Allows subsequent dilutions down to 10 volumes without additional stabilization
- Reduces the risk of packaging swelling
- Specifically for pharmaceutical applications
- High purity (manufactured from distilled-quality H₂O₂)

APPLICATIONS

- Use in pharmacy
- Use for the treatment of medical devices*
- Cosmetics

QUALITY ASSURANCE AND APPROVALS

- ISO 9001 v.2015 manufacturer, compliant with GMP requirements (Directive 2001/83/EC)
- When diluted to 30% with the appropriate quality of demineralized water, this grade complies with the specifications of the European Pharmacopoeia (Ph. Eur. 10th edition, monograph 0396)
- Shelf life: 12 months if the product is stored in its original packaging and in compliance with the conditions stated in the SDS

REGULATORY

This product is subject to regulations. The acquisition, possession, or use of these products by the general public is restricted. It cannot be sold without proof of identity and a declaration of use. No delivery will be made without compliance with this requirement.

As of February 1, 2021, the new Regulation (EU) 2019/1148 concerning explosives precursors and restricting the sale of hydrogen peroxide to the general public will enter into force and be applied throughout the European territory. Any suspicious transaction, as well as significant disappearances and thefts, must be reported to the competent national contact point.

Use as a biocide is regulated and requires a grade with marketing authorization.

*It is the sole responsibility of the medical device manufacturer to determine the suitability (including biocompatibility) of the selection of the various raw materials, products, and components, including any medical-grade quality of ARCANE INDUSTRIES products, in order to ensure that the final product intended for the user is safe, performs as intended, and complies with all applicable legal and regulatory requirements (by the FDA or other national drug safety agencies). It is the sole responsibility of the medical device manufacturer to carry out all necessary tests and inspections, evaluate the medical device based on the requirements governing its intended end use, and adequately inform and warn purchasers, users, and/or competent intermediaries (such as physicians) of relevant risks and fulfill post-market surveillance obligations. Any decision regarding the suitability of selecting an ARCANE INDUSTRIES material in a particular medical device must be based on the judgment of the manufacturer, seller, competent authority, and attending physician

Other names:

French names:

Dihydrogen dioxide
Hydrogen peroxide
Hydroperoxide
Hydrogen peroxide

English names:

Hydrogen Dioxide
Hydrogen peroxide

INCI name: HYDROGEN PEROXIDE