Amantadine hydrochloride

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Principles of method if other than guideline:

Laser diffraction according to ISO 13320-1, with evaluation according to Fraunhofer

GLP compliance:

yes (incl. QA statement)

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Amantadine hydrochloride

EC Number:

211-560-2

EC Name:

Amantadine hydrochloride

Cas Number:

665-66-7

Molecular formula:

C10H17N.ClH

IUPAC Name:

adamantan-1-amine hydrochloride

Test material form:

other: solid

Details on test material:

Name of test material (as cited in study report): 1-Aminoadamantanhydrochlrid
Analytical purity: 99.7 g/100g by 1H-NMR spectroscopy using the internal standard method (determined during the GLP-study No.
11 L00389 from Competence Center Analytics, BASF SE)
Lot/batch No.: 20110315

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 2

Percentile:

other: d(0,1)

Mean:

179 µm

Particle size 3

Percentile:

other: d(0,5)

Mean:

478 µm

Particle size 4

Percentile:

other: d(0,9)

Mean:

1 074 µm

Particle size 5

Percentile:

other: D[3,2]

Mean:

261 µm

Particle size 6

Percentile:

other: D[4,3]

Mean:

561 µm

Particle size distribution at different passages

Particle size distribution at different passages 1

Size:

< 100 µm

Distribution:

4.8 %

Particle size distribution at different passages 2

Size:

< 10 µm

Distribution:

0.3 %

Particle size distribution at different passages 3

Size:

< 4 µm

Distribution:

0 %

Any other information on results incl. tables

Results in detail:

Measurement	d(0.1) [µm]	d(0.5) [µm]	d(0.9) [µm]	D[3,2] [µm]	D[4,3] [µm]
1	183.105	483.874	1083.714	270.836	567.448
2	175.448	472.009	1063.978	252.699	555.121
Mean*	179	478	1074	261	561

*Using all single measuring points from the distributions 1 and 2, a new distribution was calculated, giving the mean values for each parameter.

< 100 µm: 4,8%; < 10 µm: 0,3%; < 4 µm: 0,0%