tert-butyl-dimethyl-piperazin-1-ylsilane

Stability in organic solvents and identity of relevant degradation products

Administrative data

Endpoint:

stability in organic solvents and identity of relevant degradation products

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-10-27 to 2016-01-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Principles of method if other than guideline:

The test substance was dissolved in corn oil at various test concentrations at room temperature, the stability of tert-butyldimethylsilanol (TBSOH) in the organic solvent was determined thereafter.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Tert-butyldimethylsilanol

Cas Number:

18173-64-3

Molecular formula:

C6H16OSi

IUPAC Name:

Tert-butyldimethylsilanol

Test material form:

liquid

Results and discussion

Test substance stable:

yes

Remarks:

The test substance was found to be stable in corn oil for 12 days at the 10.0 and 0.100 w/v% concentrations

Transformation products:

not measured

Any other information on results incl. tables

Stability analysis of test item:

The IR spectrum of the test item measured before the dosing period for the subject study was similar to that provided by the sponsor.

The IR spectrum of the test item measured after the dosing period has no difference from that measured before the dosing period

Stability and concentration analyses of test substance formulation:

The results of the stability analysis are shown in Table 1 and the results of concentration analysis are shown in Table 2

Table 1: Stability analysis of the test item formulation

Nominal concentration (w/v%)	Time point of measurement	Layer of measurement	Actual concentration (w/v%)	R.N (%)	R.P (%)
10.0	Immediately after preparation	Middle	9.94	99.4	-
	7 days after preparation	Middle	10.0	100	101
	13 days after preparation	Middle	10.1	101	102
0.100	Immediately after preparation	Middle	0.106	106	-
	7 days after preparation	Middle	0.107	107	101
	13 days after preparation	Middle	0.107	107	101

R.N = Rate to the nominal concentration

R.P = Rate to the concentration measured immediately after preparation

Table 2: Concentration analysis of the dose formulation

Date of analysis	Nominal concentration (w/v%)	Actual concentration (w/v%)	R.N (%)
November 19, 2015	10.0	9.80	98.0
	2.00	2.00	100
	0.400	0.421	105

 

Applicant's summary and conclusion

Conclusions:

TBSOH was found to be stable in corn oil after 12 days. The result is considered to be reliable.