2-(4-fluorophenyl)-5-(5-iodo-2-methylbenzyl)thiophene

Stability in organic solvents and identity of relevant degradation products

Link to relevant study record(s)

Reference

Endpoint:

stability in organic solvents and identity of relevant degradation products

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 October 2015 - 21 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

no guideline followed

Principles of method if other than guideline:

To determine the stability of formulations of the test item in propylene glycol over a large concentration range, trial formulations were prepared in vehicle at 1 mg/mL (low) and 200 mg/mL (high) and analysed according to a validated analytical method.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch: M14KB4863
Stable under storage conditions until 10 November 2017 (retest date)
Storage conditions: at room temperature

Test substance stable:

yes

Transformation products:

no

Remarks:

not specified since analysed concentrations were in agreement with nominal concentrations

The concentrations analysed in the formulations at 1 mg/mL (low) and 200 mg/mL (high) were in agreement with target concentrations. Mean accuracies should be between 85 and 115% and were 85% in the low dose group and 107% in the high dose group.

Analysis of the formulations at 1 mg/mL (low) and 200 mg/mL (high) after storage yielded a relative difference of <= 10% (-3.9% in the low dose group and -1.8% in the high dose group). Based on this, the formulations were found to be stable during storage at room temperature under normal laboratory light conditions for at least 6 h.

Conclusions:

Formulations of T003063 in propylene glycol at 1 mg/mL (low) and 200 mg/mL (high) were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours.

Description of key information

Formulations of T003063 in propylene glycol at 1 mg/mL (low) and 200 mg/mL (high) were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours, as determined by Brekelmans (2016) in a GLP study (Klimisch 1).