Reaction mass of iron chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid and sodium chloride

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:

June, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

GLP compliance:

yes (incl. QA statement)

Type of method:

capillary method

Key result

Melting / freezing pt.:

>= 201.1 - <= 203.8 °C

During the measurements the test item samples were not transparent to light and it was not possible to present the results as transmission diagrams. Then the visual observations were used. In the temperature range of 90 ⁰C to 210 ⁰C some changes in test item appearance were observed in test capillaries. However no visible melting process was detected. Probably the decomposition of less thermostable components underwent. It was only in the range of 201⁰C to 204⁰C when one observed distinct melting process and a liquid phase became visible.

Above the temperature of about 204 ⁰C the content of capillaries occupied the volume of 2 times greater than the test item initially used to do.

The determined chelate Fe(III)IDHA melting temperature,⁰C

Appearance			Melting temperature
Temperature range of observed changes in appearance,^0C		Average of range ± std. dev.,^0C	Visually determined range of melting ,^0C	Average of range ± std. dev,^0C
1	90,0 – 201,8	89,8 ± 0,4 to 201,1 ± 0,4	201,8 – 204,6	201,1 ± 0,4 to 203,8 ± 0,5
2	90,0 – 201,2		201,2 – 203,9
3	90,0 – 201,5		201,5 – 203,9
4	89,0 – 200,9		200,9 – 203,1
5	89,5 – 201,3		201,3 – 204,1
6	89,8 – 201,1		201,1 – 204,0
7	90,0 – 200,6		200,6 – 203,5
8	90,0 – 200,6		200,6 – 203,5
9	90,0 – 200,6		200,6 – 203,5

Conclusions:

The determined melting temperature of chelate Fe(III)IDHA is in the range of 201,1 ± 0,40C to 203,8 ± 0,5 0C.

Executive summary:

The study of determination of chelate Fe(III)IDHA melting temperature using device with metal block methodwas carried out in accordance with method EEC A 1:1.4.1.2.and according to principles of Good Laboratory Practice (Directive 2004/10/EC).

The determined melting temperature of chelate Fe(III)IDHA is in the range of 201,1 ± 0,40C to 203,8 ± 0,5 0C.

Description of key information

The study of determination of  chelate Fe(III)IDHA melting temperature using device with metal block method was carried out in accordance with method EEC A 1:1.4.1.2. and  according to principles of Good Laboratory Practice (Directive 2004/10/EC).
The determined melting  temperature  of test item is in the range of 201,1 ± 0,40C to 203,8 ± 0,5 0C.

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:

201.1 °C