Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 21st to 31st 2010
Reliability:
1 (reliable without restriction)

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.6 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
flask method

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

Water solubility
Water solubility:
1 229 g/L
Temp.:
20 °C
pH:
3.73

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The solubility at 20°C is 1229 g/l