Registration Dossier

Diss Factsheets

Physical & Chemical properties

Density

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct. 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
other: EUROPEAN PHARMACOPOEIA, 2.2.5. Relative density
Version / remarks:
5.0
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: DAB (Deutsches Arzneibuch) 2008; “Monographie Montanglycolwachs, Prüfung auf Identität A. Relative Dichte”
Version / remarks:
The therein cited method 2.2.N1 was used to prepare an ethanol/water mixture of the same density as the tested wax sample.
Deviations:
no
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Remarks:
2005; and GMP according to PIC/S: most recent evaluation Sept. 2016 performed by "Kantonale Heilmittelkontrolle, Regionale Fachstelle der Ost- und Zentralschweiz"
Type of method:
oscillating densitimeter
Remarks:
Density of an ethanol/water mixture of the same density as the tested wax sample was determined using the oscillating transducer density meter methodology according to EUROPEAN PHARMACOPOEIA v.5.0, method 2.2.5.
Specific details on test material used for the study:
Receipt of test item sample: 2017-03-15
Dynamic viscosity of test material:
not applicable: solid
Key result
Type:
relative density
Density:
0.992
Temp.:
20 °C

Details on replicate results - relative density of the test item D20/4:

Determination (1): 0.9931;

Determination (2): 0.9923;

Determination (3): 0.9917.

Conclusions:
Relative density D20/4 (oscillating transducer density meter): 0.9924
Executive summary:

The relative densitiy of the test item was determined in a reliable study according to DAB (Deutsches Arzneibuch, 2008) and to EUROPEAN PHARMACOPOEIA v.5.0, method 2.2.5. (oscillating transducer density meter methodology).

An ethanol/water mixture of the same density as the tested wax sample was prepared at 20°C. The relative density D20/4 thereof was determined using a digital density meter with an oscillating transducer. Three replicate determinations were performed and the following results determined for D20/4:

Determination (1): 0.9931;

Determination (2): 0.9923;

Determination (3): 0.9917;

Arithmetic mean value: 0.9924.

Description of key information

Relative density D20/4 (oscillating transducer density meter): 0.9924

Key value for chemical safety assessment

Relative density at 20C:
0.992

Additional information

The relative densitiy of the test item was determined in a reliable study according to DAB (Deutsches Arzneibuch, 2008) and to EUROPEAN PHARMACOPOEIA v.5.0, method 2.2.5. (oscillating transducer density meter methodology).

An ethanol/water mixture of the same density as the tested wax sample was prepared at 20°C. The relative density D20/4 thereof was determined using a digital density meter with an oscillating transducer. Three replicate determinations were performed and the following results determined for D20/4:

Determination (1): 0.9931;

Determination (2): 0.9923;

Determination (3): 0.9917;

Arithmetic mean value: 0.9924.

Categories Display