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Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrapotassium 5,5'-{ethane-1,2-diylbis[thio-1,3,4-thiadiazole-5,2-diyldiazene-2,1-diyl(5-amino-3-tert-butyl-1H-pyrazole-4,1-diyl)]}diisophthalate
EC Number:
700-616-6
Cas Number:
849608-59-9
Molecular formula:
C36H32K4N14O8S4
IUPAC Name:
Tetrapotassium 5,5'-{ethane-1,2-diylbis[thio-1,3,4-thiadiazole-5,2-diyldiazene-2,1-diyl(5-amino-3-tert-butyl-1H-pyrazole-4,1-diyl)]}diisophthalate

Study design

Analytical monitoring:
yes
Buffers:
Preparation of Buffer Solutions
pH 4.0 Buffer Solution
164ml of 0.2M acetic acid solution was added to 36ml of 0.2M sodium acetate and diluted to
1 litre with distilled / deionised water. The solution was degassed with helium.

pH 7.0 Buffer Solution
296ml of 0.1M sodium hydroxide solution was added to 500ml of 0.1M monopotassium
phosphate solution and diluted to 1 litre with distilled / deionised water. The solution was
degassed with helium.

pH 9.0 Buffer Solution
213ml of 0.1M sodium hydroxide solution was added to 500ml of 0.1M boric acid in 0.1M
potassium chloride and diluted to 1 litre with distilled / deionised water. The solution was
degassed with helium.
The pH of each buffer solution was measured prior to use.
Details on test conditions:
Preparation of Test Solutions
The tests were prepared in duplicate and the pH of each stable solution was measured prior
to storage at 50 ±1ºC. Analysis of the tests (by HPLC), was carried out initially and at
intervals over 5 days. Samples were weighed into 50ml volumetric flasks and buffer was
added
Duration of test
Duration:
5 d

Results and discussion

Any other information on results incl. tables

 Test  Concentration g/L  Initial result g/L  Result after 5 days g/L  Recovery after 5 days %  % loss
 pH7 (1)  6.342  6.440  6.457  100.3  -0.3
 pH7 (2)  5.854  5.936  5.953  100.3  -0.3
 pH9 (1)  6.008  6.089  6.141  100.9  -0.9
 pH9 (2)  6.476  6.540  6.742  103.1  -3.1

Applicant's summary and conclusion

Conclusions:
In conclusion - at pH 7 and 9 there has been less than 10% hydrolysis after 5 days at 50ºC.
The substance was not soluble at pH 4.