L-Lysine, N2,N6-bis[N-(1-oxododecyl)glutamyl]-, sodium salt (1:?)

Melting point / freezing point

Administrative data

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11th August 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which did not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of Inspection: 13th - 22nd of October 2008, valid for 2 years.

Type of method:

capillary method

Test material

Test material information

Constituent 1

Reference substance name:

Pellicier

IUPAC Name:

Pellicier

Details on test material:

Name: Pellicer
Lot No.: 01-09-17
Chemical name: L-Lysine, N2,N6-bis[N-(1-oxododecyl)-L-α(or γ)-glutamyl]-, sodium salt (1;?)
Appearance: White powder
Storage condition: Room temperature (15-25 °C), in the dark and protected from humidity (with desiccant)
Manufacture date: 17 January 2009
Expiry Date: 17 January 2011
Safety precautions: Routine safety and hygienic procedures sufficient to ensure personnel health and safety

Results and discussion

Melting / freezing point

Decomposition:

yes

Decomp. temp.:

517 K

Any other information on results incl. tables

During the tests the following transformation temperatures were recorded:

1. Start of decomposition: The colour of the test item changed brownish.

2. 2nd step of transition: The test item blackened.

3. Final stage of transition: The larger volume of test item moved to the upper part of the capillary. There is no liquid phase

Applicant's summary and conclusion

Conclusions:

The test material decomposes at 517K

Executive summary:

For the determination of the melting point or melting range, the capillary method was used. A small amount of the test item was heated in the electronic controlled sample block and the temperature around the sample was displayed. The sample was observed visually while raising the temperature. The initial and final melting temperatures were determined. Using a linear heating rate of 0.5 °C/min, Pellicer started to decompose, before the process of melting could be observed. In this study Pellicer started to decompose at a temperature of about 244 °C, i.e. 517 K.