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Stability in organic solvents and identity of relevant degradation products

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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. certificate)
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).

Additional information