Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
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other: GLP-compliant study, available as unpublished report, no restrictions, fully adequate for assessment.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

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 6Beta-Cl-Acetoxyprogesterone
- Substance type: Organic
- Physical state: White or almost white, crystalline powder
- Analytical purity: 94.5%
- Impurities (identity and concentrations): 6Alpha-Cl-Acetoxyprogesterone < 2%; other unknown impurities < 5%
- Purity test date: 18/01/2011
- Lot/batch No.: IMP_STE RS30.5.10
- Expiration date of the lot/batch: 5 year
- Stability under test conditions: stable

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
crystalline
Colour:
White or almost white powder.
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.