Azithromycin Dihydrate CAS No 117772-70-0

• Function: Antibiotic and Antimicrobial Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Powder
• Volatile: Not Volatile
• Model NO.: SAMREAL-0151
• Standard: USP
• Transport Package: Drum
• Specification: 25kg/drum
• Trademark: samreal
• Origin: China

Product Description

117772-70-0 Azithromycin Dihydrate

Items	Standard	Results
Characters	White or almost white powder	White powder
Solubility	Practically insoluble in water,freely soluble in anhydrous ethanol and in methylene chloride	Corresponds
Identification	A)IR:Conforms to azithromycin RS B)Rt HPLC:Conforms to azithromycin RS	Corresponds Corresponds
Crystallinity	Exhibit birefringence and extinction positions	Meets the requirements
PH	9.0~11.0	10.01
Optical Rotation	-45°~-49°	-48°
Water	4.0%~5.0%	4.37%
Residue on ignition	≤0.3%	0.02%
Limit of related substances
Azithromycin-N-oxide	≤0.5%	0.03%
3'-(N,N-didemethyl)-3-N-formylazithromycin	≤0.5%	0.01%
Erythromycin A iminoether	≤0.5%	ND
3'-(N,N-didemethyl)azithromycin (arminoazithromycin)	≤0.5%	ND
Azithromycin related compound F	≤0.5%	0.03%
Desosaminylazithromycin	≤0.3%	0.02%
3'-N-{[4-(Acetylamino)phenyl]sulfonyl}-3',3'-didemethylazithromycin	≤0.15%	0.02%
N-Demethylazithromycin	≤0.7%	ND
Erythromycin A oxime	≤0.5%	ND
Azithromycin C(3"-o-demethylazithromycin)	≤0.5%	0.06%
3'-De(dimethylamino)-3'-oxoazithromycin	≤0.5%	ND
3'-N-{[4-(Acetylamino)phenyl]sulfonyl}-3'-demethylazithromycin	≤0.5%	ND
Azaerythromycin A	≤0.5%	0.03%
Azithromycin impurity P	≤0.2%	0.05%
2-Desethyl-2-propylazithromycin	≤0.5%	0.12%
3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycin	≤0.5%	ND
3-Deoxyazithromycin(azithromycin B)	≤1.0%	0.40%
Any individual,unidentified impurity	≤0.2%	ND
Total impurities	≤3.0%	0.77%
Assay	945~1030μg/mg	985μg/mg
Residue solvents
Acetone	≤3000ppm	810PPM
Ethanol	≤2000ppm	32PPM
Chloroform	≤60ppm	<3PPM
Bulk density		0.59g/ml
Tapped density		0.72g/ml
Malvern Test	d(0.1) d(0.5) d(0.7) d(0.9) D[4,3]	29um 125um 175um 262um 137um