ProductIntroductionAzithromycin dihydrate is a macrolide antibiotic, azalide subclass. It binds to the 50S subunit of the 70S bacterial ribosomes and inhibits RNA-dependent protein synthesis in bacterial cells. Azithromycin also has anti-immunomodulatory/anti-inflammatory properties, which make it useful in treating cystic fibrosis.
Azithromycin Dihydrate
CAS No.:117772-70-0
Molecular Structure:
Synonyms:Azithromycindihydrate
Molecular Formula:C38H72N2O12.2H2O
Molecular Weight:785.01
Density:1.18g/cm3
Boiling Point:822.1°Cat760mmHg
Melting Point:113-115
ProductAnalysis
Items
Specifications
Results
Appearance
White or almost white crystalline powder
Conforms
Identification
IR
According to standard
Conforms
HPLC
According to standard
Conforms
Specific rotation
Between -45° and -49°
-47°
Crystallinity
Meets the requirements.
Conforms
pH
Btween 9.0 and 11.0
10.2
Related substances
Procedure 2
Impurity L
≤0.5%
ND
Impurity M
≤0.5%
ND
Impurity C
≤0.5%
0.04%
Impurity N
≤0.5%
0.06%
Impurity A
≤0.5%
ND
Impurity P
≤0.2%
ND
Impurity O
≤0.5%
0.24%
Impurity G
≤0.5%
0.15%
Impurity B
≤1.0%
0.3%
Any other Impurity
≤0.2%
0.18%
Total Impurity
≤3.0%
2.0%
Water
Dihydrate: Between4.0% and 5.0%
4.4%
Residue on ignition
≤0.3%
0.09%
Heavy metal
≤0.0025%
<0.0025%
Residual solvent
Acetone: ≤0.5%;
Dichloromethane: ≤0.06%
0.4%
ND
Assay(HPLC)
Between 945ug/mg and 1030ug/mg(on dry basis)
970ug/mg
Conclusion: This product conforms to requirements of USP36
Function & Application
1. Azithromycin Dihydrate is used for acute pharyngitis, acute tonsillitis caused by Streptococcus pyogenes.
2. Azithromycin is used for acute throat and tonsillitis which are caused by streptococcus pyogenes, otitis.
3. Azithromycin can treatment of media sinusitis acute bronchitis skin soft tissue infection which are caused bysensitive bacteria.
4. Azithromycin is also used for pneumonia urethritis cervicitis and so on.
Azithromycin DihydratePharmaceutical raw material
Package & Storage WhychooseUS?
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