Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
other: visual determination
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Materials and methods

Principles of method if other than guideline:
Visual determination
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2R,3R,4R,5R,8R,10R,11R,13S,14R)-11-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2S,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one
EC Number:
617-500-5
Cas Number:
83905-01-5
Molecular formula:
C38 H72 N2 O12
IUPAC Name:
2R,3R,4R,5R,8R,10R,11R,13S,14R)-11-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2S,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
crystalline
Colour:
white to off-white
Substance type:
organic

Applicant's summary and conclusion

Conclusions:
Azythromycin is a white to off-white crystalline powder.