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Physical & Chemical properties

Storage stability and reactivity towards container material

Administrative data

Endpoint:
storage stability and reactivity towards container material
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 13th November 2012 to 6th March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as reliable without restriction accordin to Klimisch et al.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
CIPAC MT 46.3 (Storage Stability)
Deviations:
no
GLP compliance:
yes
Type of method:
accelerated testing

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 3-((2,3-dicyanophenyl)sulfonyl)propane-1-sulfonate
EC Number:
696-126-4
Cas Number:
886592-17-2
Molecular formula:
C11H9N2O5S2Na
IUPAC Name:
sodium 3-((2,3-dicyanophenyl)sulfonyl)propane-1-sulfonate
Specific details on test material used for the study:
Reactivials with inert tops were filled, in duplicate, to give minimum headspace with the Test material. The vials were then sealed with tape and labelled before weighing. A blank vial was also prepared. The vials were placed in an oven for 14 days at 54 ± 2ºC.

After 14 days the vials were removed from storage and left to reach room temperature before the appearance and weight of the vials were recorded.
The strength of the Test Item after storing was also determined by HPLC. In the absence of a reference material of the Test material the stability
test material was compared with the Test material stored at ambient temperature.

Results and discussion

Results:
- No change in the appearance of the test material was noted.
- The weight loss of the Test Item was consistent with the weight loss of the blank vial and therefore not considered significant.
- The HPLC purity of the sample after 14 days at 54°C ± 2°C is 99.4% peak area at 254nm. The impurity profile of the Test Item after 14 days at 54°C ± 2°C is the same as the unstressed sample.
- The HPLC results show that there has not been a significant change in the test material on storage at 54°C ± 2°C after 14 days.
Transformation products:
no

Applicant's summary and conclusion

Conclusions:
Over the test time period the test material was shown to be stable. Therefore, there had not been any significant active ingredient degradation and according to CIPAC MT 46 this indicates an ambient shelf life of at least 2 years.
Executive summary:

Introduction

This study was undertaken to determine the storage stability of the test material. The method used was in accordance with CIPAC MT 46.

Results & Conclusions

After heating at 54ºC for 14 days no change in the appearance of the test material was noted. -The weight loss of the Test material was consistent with the weight loss of the blank vial and therefore not considered significant. The HPLC purity of the sample after 14 days at 54°C ± 2°C is 99.4% peak area at 254nm. The impurity profile of the Test material after 14 days at 54°C ± 2°C is the same as the unstressed sample. The HPLC results show that there has not been a significant change in the test material on storage at 54°C ± 2°C after 14 days.