Ichthammol

Density

Administrative data

Endpoint:

relative density

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

test results from ongoing batchwise testing of the substance

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.). In the European Pharmacopoeia "relative density" is specified for Ichthammol in monograph 0917. Release procedures for Ichthammol require regular (batchwise) measurements of specification parameter "relative density" which the registrant conducts in its own laboratory.

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 monograph 0917 with reference to chapter 2.2.5 "relative density"

Version / remarks:

Relative density (2.2.5): 1.040 to 1.085, determined on a mixture of equal volumes of the substance to be examined and water.

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

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:

The test substance is analyzed batchwise for "relative density"

Results and discussion

Density

Key result

Type:

relative density

Density:

>= 1.04 - 1.085

Temp.:

20 °C

Remarks on result:

other: determined on a mixture of equal volumes of the substance to be examined and water

Applicant's summary and conclusion

Conclusions:

Ichthammol is distinguished by a "relative density" in the range of 1.040 to 1.085 at a temperature of 20°C (determined on equal volumes of Ichthammol and water). Actually, the range given is the specification range for this substance according to European Pharmacopoeia requirements. Relative density is measured batchwise. A non-compliant (oos) material is not released for sale.