Ichthammol

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

ongoing laboratory work for "inprocess controls" and batch release

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

Generally accepted standards in this case means reference to pharmacopoeias as e.g. the European Pharmacopoeia Ph.Eur.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: company internal operation procedure with reference to official European Pharmacopeia provisions (monograph Ichthammol 0917)

Version / remarks:

test instructions ICHTH-Rohstoffe PA-001 version 05 dated October 13th, 2014
(with reference to European Pharmacopoeia monograph Ichthammol)

Deviations:

not applicable

Principles of method if other than guideline:

company internal testing instructions based on European Pharmacopoeia requirements
monograph 0917 Ichthammol

Ichthammol
Characters
Appearance: dense, blackish-brown liquid.
Solubility: miscible with water and with glycerol, slightly soluble in ethanol (96 per cent), in fatty oils and in liquid paraffin. It forms homogeneous mixtures with wool fat and soft paraffin.

The term ‘miscible’ is used to describe a liquid that is miscible in all proportions with the stated solvent.

Other quality assurance:

other: laboratory in a GMP certified pharmaceutical company

Test material

Test material information

1

Reference substance name:

Ichthammol

EC Number:

232-439-0

EC Name:

Ichthammol

Cas Number:

8029-68-3

Molecular formula:

unspecified

IUPAC Name:

Ichthammol (UVCB substance)

Test material form:

liquid: viscous

Details on test material:

sample from a batch from regular production released for use as an active pharmaceutical ingredient in medicinal products.

Specific details on test material used for the study:

batch 0050218415Ö2/18

Results and discussion

Water solubility

Water solubility:

> 500 g/L

Conc. based on:

other: Water has to be regarded as an intrinsic part of the test substance. 500 g/L refers to the content of dry matter with reference to the total substance comprising water and dry matter (organic sulfonate salt).

Temp.:

20 °C

pH:

>= 6 - <= 7.5

Remarks on result:

completely miscible

Applicant's summary and conclusion

Conclusions:

In the literature Sulfonated Shale Oils or bituminosulfonates (as Ichthammol or Ichthyolic Acid, Sodium Salt) are described as viscous, brown-blackish, neutral liquids of characteristic odor. Their status as liquids results from the fact that water appearing as a by-product in course of the manufacturing process (sulfonation and neutralization of a distillate resulting from destructive distillation of organic matter rich limestones) is considered an intrinsic part of the substance. It can be concluded, therefore, that there is no repulsion when bringing the substance in contact with water. Actually, sulfonated shale oils or bituminosulfonates are described in the literature as strongly polar compounds, water soluble, surface active and solubilizing. Water solubility of ICHTHYOL as trademark substance of this group of substances was described in the open literature already more than 100 years ago. In this case evidence is given about the water solubility of Ichthammol by means of an exemplary batch related certificate of analysis which is based on specifications established in the European Pharmacopoeia (monograph 0917 Ichthammol).