Registration Dossier

Administrative data

Endpoint:
vapour pressure
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:
OECD Guideline 104 (Vapour Pressure Curve)
Deviations:
no
GLP compliance:
yes
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
gas saturation method

Test material

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

Results and discussion

Vapour pressure
Key result
Temp.:
30 °C
Vapour pressure:
0.042 Pa

Applicant's summary and conclusion

Conclusions:
Vapour pressure for Thioctamidoethyl Dimethylamine Maleate is 0.0422 Pascal at 30°C is performed as per Gas saturation method using flow meter as per Indian Pharmaopeia 2014