Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 21st to August 26th 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test made according to guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Deviations:
no
GLP compliance:
no
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Product Name: L-Carnitine-L-Tartrate
Producer: Chengda Pharmaceuticals Co., Ltd., China
Batch No.: 1001003
Manufacturing Date: 2010.01.03
Expiry Date: 2012.01.02

Results and discussion

Partition coefficient
Type:
log Pow
Partition coefficient:
-2.9
Temp.:
50 °C
pH:
5.54

Applicant's summary and conclusion

Conclusions:
The partition coefficient n-octanol-water (Pow) at 50°C and pH 5.54 is 0.0012. The standard deviation is 0.0002.