Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
Storage stability and reactivity towards container material
Administrative data
Link to relevant study record(s)
- Endpoint:
- storage stability and reactivity towards container material
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- AV 90.1 according to TRV002 (laboratory method A-B-C)
- GLP compliance:
- no
- Type of method:
- testing for reactivity towards container material
- Endpoint:
- storage stability and reactivity towards container material
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Specific details on test material used for the study:
- TEST CONDITIONS
- Temperature: 25 +/- 2°C
- Humidity: 60 +/- 5%
Referenceopen allclose all
Compatible container materials are: Hostalen GM 6255, Lupolen 4261 AGUV
Results indicate a slow increase of the "related substances" at a relatively constant pH and a usual formation of p-chloroaniline.
Since the 2004 production, all stability test lots fulfilled complete EP specification requirements for at least 2 years. Based on the stability data, the established retest period of 24 months is still recommended.
Description of key information
Compatible container materials for Chlorhexidin-digluconat 20% solution are: Hostalen GM 6255, Lupolen 4261 AGUV
Additional information
Compatible container materials are: Hostalen GM 6255, Lupolen 4261 AGUV
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