Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 12th to 27th 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Tests perfomed according to guideline.
Cross-reference
Reason / purpose:
reference to other study

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.3 (Relative Density)
GLP compliance:
no
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
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

Density
Type:
relative density
Density:
1.216
Temp.:
20 °C

Applicant's summary and conclusion

Conclusions:
The relative density of the substance at 20°C is 1.2161. The error is 0,1%.