Ichthyolic acid, sodium salt

Density

Administrative data

Endpoint:

relative density

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

The registrant is pharmaceutical manufacturer and as such subject of regular inspections by health authorities. The registrant complies with EU guidelines for "Good Manufacturing Practice" (GMP) and works with analytical methods given in the European Pharmacopoeia (Ph.Eur.).

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: European Pharmacopoeia chapter 2.2.5 "relative density"

Version / remarks:

European Pharmacopoeia 9th edition

Deviations:

no

Principles of method if other than guideline:

European Pharmacopoeia 2.2.5 "Relative density"

The relative density of a substance is the ratio of the mass of a certain volume of a substance at temperature t1 to the mass of an equal volume of water at temperature t2.

Relative density or density are measured with the precision to the number of decimals prescribed in the monograph using a density bottle (solids or liquids), a hydrostatic balance (solids), a hydrometer (liquids) or a digital density meter with an oscillating transducer (liquids and gases). When the determination is made by weighing, the buoyancy of air is disregarded, which may introduce an error of 1 unit in the 3rd decimal place. When using a density meter, the buoyancy of air has no influence.

GLP compliance:

no

Remarks:

The laboratory measuring "relative density" works according to GMP requirements (certificate available).

Other quality assurance:

other: GMP

Type of method:

oscillating densitimeter

Test material

Test material information

Constituent 1

Reference substance name:

Ichthyolic acid, sodium salt

EC Number:

215-671-7

EC Name:

Ichthyolic acid, sodium salt

Cas Number:

1340-06-3

IUPAC Name:

Identification of the UVCB substance by "Chemcial Abstracts Index Name", among others: Ichthyolic Acid, Sodium Salt. No IUPAC name known.

Test material form:

liquid

Specific details on test material used for the study:

The test substance is analyzed batchwise for "relative density"

Dynamic viscosity of test material:

not applicable

Results and discussion

Density

Key result

Type:

relative density

Density:

>= 1.15 - <= 1.25

Temp.:

20 °C

Applicant's summary and conclusion

Conclusions:

Ichthyolic Acid, Sodium Salt (trademark substance ICHTHYOL PALE) is distinguished by a "relative density" in the range of 1.15 to 1.25 at a temperature of 20°C. Actually, the range given is the specification range for this substance. Relative density is measured batchwise. A non-compliant (oos) material is not released for sale.