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ICHTHAMMOL EP, BP and USP grades

Description:

ICHTHAMMOL the ammonium salt of dark sulfonated shale oil (DSSO) is used successfully as active
pharmaceutical ingredient of natural origin for more than 100 years in treatment of skin disorders.
Ichthammol is a product of natural origin obtained in the first step by dry distillation of sulfur-rich oil
shale. It is used in medicine as a remedy for treating some skin diseases, such as acne, eczema and
psoriasis.
Pharmacologically, DSSO have anti-inflammatory, bactericidal and fungicidal properties. It used in
such preparations like:

    - Suppositories with Ichthammol - anti-inflammatory agent topically-applied for pelvic organs;
    - Ichthammol ointment - commonly used in 10% or 20% concentrate ointment form as a

         remedy for treating some skin diseases, such as acne, eczema and psoriasis.
    - Ichthammol-nathtalan ointment – use as a remedy for inflammatory skin and muscle

         diseases, radiculitis and decubitus

                       Specifications                  Accepted limits

1 Formation of a resinous precipitate   EP, BP grades                   USP grade
2 Reaction of ammonium salts
3 Identification of Sulphur             Corresponds                     Corresponds
4 Acidity of Alkalinity
5 Sulphated Ash, max                    Corresponds                     Corresponds
6 Dry Matter
7 Total Sulphur, min                    Corresponds                     Corresponds
8 Sulphur in the form of Sulphate, max
9 Organically combined Sulphur, min     Corresponds                     Corresponds
10 Ammonium Sulphate, max
11 Total ammonia                        0.3%                            0.3%
12 Relative density
                                        50.0 – 56.0 %                   50.0 – 56.0 %
13 Consistency and Colour
                                        14.0%                           10.0%
14 Miscibility water and glycerol
                                        20.0%                       Not determinated

                                        10.5%                       Not determinated

                                        Not determinated                8%

                                        4.5 – 7.0%                      2.5% Min.

                                        1.040 – 1.085                   1.040 – 1.085

                                        Dense, blackish-brown       Dense, blackish-brown

                                        liquid with specific smell  liquid with specific smell

                                        Complete                        Complete

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