Specification:
|
Item
|
Index
|
|
CHARACTERISTICS
|
WHITE CRYSTALLINE POWDER
|
|
SPECIFIC ROTATION
|
-45~-49°
|
|
CRYSTALLINITY
|
CONFORMS
|
|
PH
|
9.0~11.0
|
|
WATER
|
4.0~5.0%
|
|
RESIDUE ON IGNITION
|
≤0.3%
|
|
HEAVY METALS
|
≤25PPM
|
|
ASSAY (HPLC DRIED SUBSTANCE)
|
945μg/mg~1030μg/mg
|
|
RELATIVE SUBSTANCE
|
≤1.0%
|
|
1.DESOSAMINYLAZITHROMYCIN
|
≤0.3%
|
|
N-DEMETHYLAZITHROMYCIN
|
≤0.7%
|
|
2. ANY OTHER IMPURITY
|
|
|
3. TOTAL IMPURITY
|
≤3.0%
|
|
1. METHYLENE CHLORIDE
|
≤0.06%
|
|
2. ACETONE
|
≤0.5%
|