Calcium (S)-2-hydroxypropionate

Dissociation constant

Link to relevant study record(s)

Reference

Endpoint:

dissociation constant

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-05-18 to 2013-08-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 112 (Dissociation Constants in Water)

Version / remarks:

adopted 12 May 1981

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Name of test material: PURACAL PP/USP (Calcium-L-Lactate 5-Hydrate Powder USP)
- Physical state: white crystalline powder
- Analytical purity: 99.9%
- Lot/batch No.: 1107003133
- Expiry date: 2016-07-29
- Storage condition of test material: 15-30 °C

Dissociating properties:

no

No.:

#1

Temp.:

20 °C

Remarks on result:

not determinable

Remarks:

Conclusion: The test item has no weakly dissociable groups

No sufficient difference between the titration curve of sample and the control samples was observed and therefore no pKa could be established. On this basis, it is concluded that the test item PURACAL PP/USP has no weakly dissociable group; therefore the dissociation constant is not applicable for this test substance.

Conclusions:

Calcium (S)-lactate does not dissociate within the pH range prescribed by OECD test guideline 112 (pH 2-12).

Executive summary:

In a GLP study conducted according to OECD 112, the dissociation constant of calcium (S)-lactate was determined by titration. No measurable dissociation constant has been determined using this method in the pH range of 2-12.

Description of key information

Calcium (S)-lactate does not dissociate within the pH range prescribed by OECD test guideline 112 (pH 2–12).