ICHTHAMMOL® the ammonium salt of dark sulfonated shale oil is used successfully as active pharmaceutical ingredient of natural origin for more than 100 years in treatment of skin disorders. Convince yourself on the following pages about the well documented quality and proven efficacy spectrum of this well tolerated substance.
Guarantee for good quality
In human and veterinary medicine ICHTHAMMOL® belongs to the few exceptions of well documented active ingredients of natural origin. The dark sulfonated shale oil is manufactured by Österreichische Ichthyol-Gesellschaft in Seefeld / Austria according to the requirements of different pharmacopoeias (Ph. Eur.). These requirements involve manufacture of ICHTHAMMOL® in constantly good quality in compliance with guidelines of good manufacturing practice (GMP) under consideration of general criteria (e.g. residual solvents) as well as the individual specifications of the monograph.
For pharmacopoeia compliant ICHTHAMMOL® compliance with the basic definition of this active ingredient is indispensable. For ICHTHAMMOL® manufacture from certain bituminous schists (oil shales) as starting material is mandatory. Materials deviating from this definition cannot be referred to as ICHTHAMMOL® and have to be treated as counterfeit drugs.
On account of conformity of ICHTHAMMOL® from Seefeld with pharmacopoeias provisions, for Ph. Eur. quality the existing certificate of suitability (CEP) by the EDQM was renewed under registration number R1-CEP-2001-274-REV 01.
Österreichische Ichthyol-Gesellschaft is in the position to guarantee for our ICHTHAMMOL high purity with regard to toxicologically critical substances (e.g. Benzo[a]pyrene < 0.05 ppm). For this reason and because of the comprehensive up to date documentation available this ICHTHAMMOL® could be evaluated as uncritical and safe in course of the MRL (maximum residue limits) procedure (directive (EEC) 2377/90). ICHTHAMMOL®, therefore, can be applied locally in veterinary medicine unrestricted in all food-producing mammalian animals (including milk-producing ones).
The anti-inflammatory, antibacterial and antimycotic actions of ICHTHAMMOL® offer a broad spectrum of efficacy and constitute the basis for a successful application of this active ingredient in treatment of different painful skin disorders with and without microbial background.
|manufacture:||Seefeld / Austria|
|quality:||Ph.Eur. (BP), USP among others|
|Synonyme:||dark sulfonated shale oil, ammonium salt|