Registration Dossier

Administrative data

Endpoint:
stability: thermal, sunlight, metals, other
Remarks:
Migrated from section 'Stability: thermal, sunlight, metals'
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Omeprazole chloromethylpyridine
- Substance type: organic
- Physical state: solid
- Analytical purity: 100 % (HPLC area percent)
- Purity test date: 02. 2008
- Lot/batch No.: 30000859
- Expiration date of the lot/batch: 01. 2009

Results and discussion

Applicant's summary and conclusion

Conclusions:
According to DSC result no exothermal process is detected below 300°C. The temperature during the substance use is below 60 °C.