Category
Azithromycin
CAS Number
STD- 83905-01-5: IMP-A- 76801-85-9 : IMP-B- 307974-61-4: IMP-C- 620169-47-3: IMP-E- 612069-27-9: IMP-F (RC-F) 612069-28-0: IMP-G- 612069-31-5: IMP-I- 172617-84-4 : IMP-J(RC-J)- 117693-41-1: IMP-L- 90503-06-3: IMP-M- 765927-71-7: IMP-N- 612069-25-7
Molecular Formula
STD- C38H72N2O12: IMP-A- C37H70N2O12 : IMP-B- C38H72N2O11: IMP-C- C37H70N2O12: IMP-E- C36H68N2O12: IMP-F (RC-F)- C38H70N2O13: IMP-G- C44H76N2O14S : IMP-I- C37H70N2O12 : IMP-J(RC-J)- C30H58N2O9 : IMP-L- C38H72N2O13 : IMP-M- C37H68N2O13
Molecular Weight
STD- 748.98: IMP-A- 735 : IMP-B- 733: IMP-C- 735: IMP-E- 720.9: IMP-F (RC-F)- 763.0: IMP-G- 889.1: IMP-I- 735 : IMP-J(RC-J)- 590.8: IMP-L- 765: IMP-M- 748.9: IMP-N- 719.9: IMP-O- 763 : IMP-P- 763
Synonym

Azithromycin ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-(((2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity A ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,8,10,12,14-hexamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity B ((2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-4,10-dihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity C ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2R,4R,5S,6S)-4,5-dihydroxy-4,6-dimethyloxan-2-yl]oxy-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity E((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-amino-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity F (3′-N-demethyl-3′-N-formylazithromycin, Azithromycin USP Related Compound F)

Azithromycin EP Impurity G (N-[(2S,3R,4S,6R)-2-[[(2R,3S,4R,5R,8R,10R,11R,12S,13S, 14R) -2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadec-11-yl]oxy]-3-hydroxy-6-methyloxan-4-yl]-N,4-dimethylbenzenesulfonamide)

Azithromycin EP Impurity I ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-11-[(2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity J ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3,4,10,13-tetrahydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino-Beta-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity L((2S,3R,4S,6R)-2-[[(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadec-11-yl]oxy]-3-hydroxy-N,N,6-trimethyloxan-4-amine oxide)

Azithromycin EP Impurity M (N-[(2S,3R,4S,6R)-2-[[(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadec-11-yl]oxy]-3-hydroxy-6-methyloxan-4-yl]formamide)

Azithromycin EP Impurity N ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-11-[(2S,3S,6R)-3-hydroxy-6-methyl-4-oxooxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity O ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-2-propyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin EP Impurity P (11-[4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2,6-diethyl-3,4,10-trihydroxy-13-(5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl)oxy-3,5,8,10,12,14-hexamethyl-1-oxa-6-azacyclopentadecan-15-one)

Azithromycin for Peak Identification CRS is a certified reference standard (CRS) designed for accurate identification and quantification of Azithromycin during chromatographic analysis. It is used to establish system suitability, confirm retention time, and verify method performance during analytical method validation, quality control, and regulatory submissions. This standard complies with pharmacopeial requirements (USP, EP, BP) and is widely used for ANDA, DMF, and GMP submissions.