Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Remarks:
SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH, 14-15, Sadarmangala Industrial Area, Whitefield Road, Bengaluru-560048
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
GLP compliance:
yes
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
Laser scattering/diffraction

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk

Results and discussion

Mass median aerodynamic diameter:
<= 0.95 nm
Particle size
Key result
Percentile:
D50
Mean:
<= 0.95 nm
Remarks on result:
other: Partile size of the sample is lower than instrumet detection limit 0.950nm

Applicant's summary and conclusion

Conclusions:
Particle size of Thioctamidoethyl Dimethylamine Maleate is lower than instrument detection limit 0.950nm performed as per laser diffraction method using partile size analyser over the size range of 0.2-1400 microns.