Norfloxacin EP Impurity E
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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

75001-78-4Norfloxacin EP Impurity E

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Catalogue No.:VL3030002
CAS No.:75001-78-4
Mol. Formula:C16H18ClN3O3 . HCl
Mol. Weight:335.79 (base) ; 372.25 (HCl Salt)

Additional information on CAS 75001-78-4

Parent drug

Norfloxacin

IUPAC Name

7-Chloro-1-ethyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid HCl

Pharmacopoeial Synonyms

Norfloxacin Related Compound E

Other Synonyms

Norfloxacin Ethyl Ester;1-ethyl-6-fluoro-7-(1-piperazinyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid ethyl ester; Norfloxacin HCl 7-Chloro Analog

Smile

O=C(C1=CN(CC)C2=C(C=C(N3CCNCC3)C(Cl)=C2)C1=O)O.[H]Cl

Inchl

InChI=1S/C16H18ClN3O3.ClH/c1-2-19-9-11(16(22)23)15(21)10-7-14(12(17)8-13(10)19)20-5-3-18-4-6-20;/h7-9,18H,2-6H2,1H3,(H,22,23);1H

Description

Norfloxacin EP Impurity E, also described as Norfloxacin HCl 7-Chloro Analog and Norfloxacin Related Compound E, is the hydrochloride of a fluoroquinolone process impurity associated with halogen-pattern isomerism within the norfloxacin synthetic family. CAS 75001-78-4; formula C16H18ClN3O3 . HCl; molecular weight 372.25 for the salt, corresponding to 335.79 for the free base. Its presence is typically linked to route-dependent chlorinated precursor carryover or late-stage substitutional misincorporation rather than oxidative degradation. Characterization generally requires LC-MS/MS, HPLC with photodiode array detection, and, when structural confirmation is needed, NMR and HRMS. Such impurities are assessed under pharmacopeial and ICH impurity-control expectations.

References

Mielji, Branislava, et al. “Column High-Performance Liquid Chromatographic Determination of Norfloxacin and Its Main Impurities in Pharmaceuticals.” Journal of AOAC INTERNATIONAL, vol. 91, no. 2, Mar. 2008, pp. 332–38, https://doi.org/10.1093/jaoac/91.2.332 Kaplowitz, Lisa G., et al. “Norfloxacin in the Treatment of Uncomplicated Gonococcal Infections.” The American Journal of Medicine, vol. 82, no. 6, June 1987, pp. 35–39, https://doi.org/10.1016/0002-9343(87)90616-4.?

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