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
- Specific to 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/BPF requirements (Directive 2001/83/EC)
- When diluted to 30% with the appropriate demineralized water quality, 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 accordance with the conditions stated in the SDS

REGULATORY

This product is subject to regulation. 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 intended use. No delivery will be made without a response to this requirement.

As of February 1, 2021, the new regulation (EU) 2019/1148 concerning possible explosive precursors and restricting the sale of hydrogen peroxide to the general public will enter into force and will be applied throughout the European territory. Any suspicious transaction, as well as significant disappearances and thefts, must be reported to the relevant 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 choice of the various raw materials, products and components, including any medical-quality grade of ARCANE INDUSTRIES products, in order to ensure that the final product intended for the user is safe, functions 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, to evaluate the medical device on the basis of the requirements governing its end use and to adequately inform and warn the relevant purchasers, users and/or intermediaries (such as physicians) of the relevant risks and to fulfill post-marketing surveillance obligations. Any decision regarding the suitability of an ARCANE INDUSTRIES material in a particular medical device must be based on the judgment of the manufacturer, the seller, the competent authority and the treating physician.

Other names:

French names:

Dihydrogen dioxide
Eau oxygénée
Hydroperoxide
Peroxyde d'hydrogène

English names:

Hydrogen Dioxide
Hydrogen peroxide

INCI Name: HYDROGEN PEROXIDE