Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Remarks:
Sample sent to 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:
other: As per Indian Pharmacopoeia 2014
Deviations:
no
GLP compliance:
yes
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
capillary method

Test material

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

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
>= 122 - <= 122 °C
Remarks on result:
other: Determined as per Indian Pharmaopeia 2014

Applicant's summary and conclusion

Conclusions:
Melting Point for Thioctamidoethyl Dimethylamine Maleate is 122°C, performed as per Indian Pharmacopoeia 2014 Guidelines.