Registration Dossier
Registration Dossier
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EC number: 941-489-9 | CAS number: -
Appearance / physical state / colour
Administrative data
- Endpoint:
- appearance / physical state / colour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant study, available as unpublished report, no restrictions, fully adequate for assessment. Standard Operating Procedure are applied from the Lead Registrant to analyze the substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6alfa-fluoro epossido prednisolone 21-acetato
- IUPAC Name:
- 6alfa-fluoro epossido prednisolone 21-acetato
- Details on test material:
- - Name of test material (as cited in study report): 6alfa-fluoro epossido prednisolone 21-acetato
- Substance type: Organic
- Physical state: White or light brown, crystalline powder
- Analytical purity: 92.43%
- Impurities (identity and concentrations): see section 1.2
- Lot/batch No.: 31103F0 0091400
- Expiration date of the lot/batch: 2 year
- Stability under test conditions: stable
Constituent 1
Results and discussion
- Physical state at 20°C and 1013 hPa:
- solid
Form / colour / odour
- Form:
- crystalline
- Colour:
- White or light brown.
- Substance type:
- organic
Applicant's summary and conclusion
- Conclusions:
- Characteristics of the product are obtained directly from the Standard Operating Procedure applied from the Lead Registrant to analyze the substance.
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