tert-butyl {(1S)-2-[(1S,3S,5S)-3-cyano-2-azabicyclo[3.1.0]hex-2-yl]-1-[3-hydroxyadamantan-1-yl]-2-oxoethyl}carbamate

Vapour pressure

Administrative data

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 03 February and 14 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

using the vapor pressure balance method, designed to be compatible with Method A4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: vapour pressure balance

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Identification: BMS-528235-01
Description: Off white powder
Batch: 1L63487N
Purity: 98.6%
Expiry / Retest Date: 27 November 2014
Storage Conditions: Room temperature in the dark

Results and discussion

Vapour pressure

Temp.:

25 °C

Vapour pressure:

Pa

Remarks on result:

other: The vapor pressure of the test item has been determined to be 1.4 x 10-13 Pa at 25 ºC.

Transition / decomposition

Transition / decomposition:

no

Any other information on results incl. tables

Please find details of the results in table and graph format within Attachment 3.

Applicant's summary and conclusion

Conclusions:

The vapor pressure of the test item has been determined to be 1.4 x 10-13 Pa at 25 ºC..

Executive summary:

Principle of the Test

The vapor pressure was determined using a vapor pressure balance with measurements being made at several temperatures and linear regression analysis used to calculate the vapor pressure at 25 °C.

The determination was carried out using a procedure designed to be compatible with Method A4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Summary of Results

 

Run	Log10 [Vp(25 ºC)]
4	-13.3
5	-12.8
6	-13.1
7	-13.0
8	-12.6
9	-12.9
10	-12.4
Mean	-12.9
Vapor Pressure	1.4 x 10^-13Pa

 

The test item did not change in appearance under the conditions used in the determination.

Conclusion

The vapor pressure of the test item has been determined to be 1.4 x 10^-13Pa at 25 ºC.