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Physical & Chemical properties

Storage stability and reactivity towards container material

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Administrative data

Endpoint:
storage stability and reactivity towards container material
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study Experimental Work 2013-03-26 to 2013-05-31. Study report complete 2013-10-10.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
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:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
EC Number:
700-787-7
Cas Number:
769953-18-6
Molecular formula:
C11H9N2O3S2Li
IUPAC Name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
Test material form:
solid: particulate/powder
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 equilibrate at room temperature before the appearance and weight of the vials were recorded.

The strength and impurity profile of the test item after storage was also determined by HPLC. In the absence of any appropriate reference material, the stability test material was compared with the test item stored at ambient temperature.

Results and discussion

Results:
PRODUCT APPEARANCE
No change in the appearance of the test item was noted.

MASS CHANGES
The weight loss of the test item was consistent with the weight loss of the blank vial and therefore not considered significant.

Test
Blank vial: Weight (g) 28.42544, % w/w loss 0.14
Test 1: Weight (g) 31.17665, % w/w loss 0.14
Test 2: Weight (g) 30.88487, % w/w loss 0.15

The accelerated storage strength of the test item, after 14 days at 54°C ± 2°C is 101.1% w/w of unstressed test item. See table below for individual results of the duplicate injections of Test 1 and Test 2 and also for mean value.

Test % w/w Mean % w/w
Test 1 (1) 98.7 98.9
98.2
Test 1 (2) 99.5
99.1

The impurity profile of the test item after 14 days at 54°C ± 2°C is the same as the unstressed sample.


Applicant's summary and conclusion

Conclusions:
Over the test time period the sample has been shown to be stable. Therefore, there has 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.

Results & Conclusions

The weight loss of the test item was consistent with the weight loss of the blank vial and therefore not considered significant. The accelerated storage strength of the test item, after 14 days at 54°C ± 2°C is 101.1% w/w of unstressed test item. Over the test time period the sample has been shown to be stable. Therefore, there has not been any significant active ingredient degradation and according to CIPAC MT 46 this indicates an ambient shelf life of at least 2 years.

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