Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern study peformed under GLP and using the recommended method, EU method A.6.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material received from F. Hoffmann-La Roche Ltd was a white solid powder from lot no. 25927 with a purity of 99.8%.

Results and discussion

Water solubility
Water solubility:
1.65 g/L
Temp.:
20 °C
Details on results:
The water solubility of PTH-decahydroamide (Ro 31-9373/000) was determined to be 1.65 g/L at 20 ⁰C using the flask method.

Any other information on results incl. tables

A tendency to increasing values of water solubility was noticed from the results of days 1, 2 and 3. Therefore vessel 3 was equilibrated for a further fourth day. The water solubility value for the fourth day was not significant different to the value obtained on day 2. An average was therefore generated for the last three experimental days. The results are reported in the table below;

Equilibration Time

pH at 30 ⁰C (hours)

pH

Initial PTH-Decahydroamide Weight (g)

Solubility (in g/L saturated solution)

Found PTH-Decahydroamide (g) in 200 mL water

24

10.25

0.4991

1.69

0.338

48

10.14

0.5037

1.58

0.316

72

10.18

0.4997

1.76

0.352

168

10.10

0.4997

1.61

0.322

Average (last 3 days)

1.65

 

Std. Dev.

0.10

 

Rel. Std. Dev.

6%

 

n

3

 

The water solubility of PTH-decahydroamide (Ro 31-9373/000) was determined to be 1.65 g/L at 20 ⁰C using the flask method. The standard deviation between the solubilities for the last three days was 6% which is below the maximum 15% accepted in the guidelines.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
The water solubility of PTH-decahydroamide (Ro 31-9373/000) was determined to be 1.65 g/L at 20 ⁰C using the flask method.
Executive summary:

The water solubility of PTH-decahydroamide was determined using the EU method, A.6 (1992). The water solubility of PTH-decahydroamide (Ro 31-9373/000) was determined to be 1.65 g/L at 20 ⁰C using the flask method. PTH-decahydroamide was concluded to be soluble in water.