[2S-[2α,5α,6β(S*)]]-6-[[[[(4-ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid

Melting point / freezing point

Link to relevant study record(s)

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19/04/2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

capillary method

Key result

Atm. press.:

1 017.2 hPa

Decomposition:

yes

Decomp. temp.:

151 °C

Sublimation:

no

Preliminary study: At about 155.0°C, the beginning of the decomposition of the substance was observed, shown by a colour change from white to yellow. At 160ºC, the delamination of the substance took place, and at 165ºC, browning of the sample was observed.
Main test: All samples started to change colour at 151.0ºC, showing the onset of the decomposition process and, at 153.0ºC, delamination of the samples was observed.

Table 1. Observed values for the decomposition temperature of the test item.

Sample	Atmospheric pressure, hPa	Initial decomposition temperature, °C
1	1017.2	151.0
2		151.0
3		151.0
Average ± standard deviation		151.0

Conclusions:

The test item decomposes at 151.0 °C (1017.2 hPa).

Executive summary:

A study to determine the melting point of the test item was performed according to EU method A.1 (capillary method) / OECD 102, under GLP conditions. A preliminary test was carried out in order to determine the melting temperature range for test item. Based on the results of the preliminary test, a main test consisting of three series of measurements in the range of 150.0 °C – 400.0 °C was performed. All samples started to change colour at 151.0ºC, showing the onset of the decomposition process and, at 153.0ºC, delamination of the samples was observed. Therefore, the test item decomposes below the melting point under atmospheric pressure (1017.2 hPa). Under test conditions, the test item decomposes at 151.0 °C.

Description of key information

Key study. Method according to OECD 102, GLP study. The test item decomposes at 151.0 °C (at 1017.2 hPa).

Additional information

The determination of the boiling point of the test item was carried out according to EU method A.1 (capillary method) / OECD 102, under GLP conditions. All samples started to change colour at 151.0ºC, showing the onset of the decomposition process and, at 153.0ºC, delamination of the samples was observed. Therefore, the test item decomposes at 151.0 °C (at 1017.2 hPa).