N-Nitroso of ZTA-III Impurity (Azithromycin)

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Catalogue No.:	VE007866
CAS No.:	N/A
Mol. Formula:	C37H69N3O13
Mol. Weight:	763.96 g/mol

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Additional information on N-Nitroso of ZTA-III Impurity (Azithromycin)

Parent drug

Azithromycin

IUPAC Name

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

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=C1[C@H](C)[C@@H](OC2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@H]3[C@@H](O)[C@@H](N(C)C)C[C@H](C)O3)[C@](C)(O)C[C@@H](C)CN(N=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)O1

InChI

InChI=1S/C37H69N3O13/c1-14-26-37(10,46)30(42)23(6)40(38-47)18-19(2)16-35(8,45)32(53-34-28(41)25(39(11)12)15-20(3)49-34)21(4)29(22(5)33(44)51-26)52-27-17-36(9,48-13)31(43)24(7)50-27/h19-32,34,41-43,45-46H,14-18H2,1-13H3/t19-,20+,21+,22-,23-,24+,25+,26-,27?,28+,29+,30-,31+,32-,34+,35-,36-,37-/m1/s1

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Description

N-Nitroso of ZTA-III Impurity (Azithromycin) is an N-nitroso derivative of the secondary amine present in Azithromycin | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Azithromycin production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.