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Documentation

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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.

N-Nitroso Desmethyl Tigecycline 2

● Under Development

Catalogue No.:	VE0017343
CAS No.:	N/A
Mol. Formula:	C28H36N6O9
Mol. Weight:	600.62 g/mol

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Additional information on N-Nitroso Desmethyl Tigecycline 2

FDA Potency Category 2 NDSRI

100 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-desmethyl-tigecycline-2 (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.

Parent drug

Tigecycline

IUPAC Name

(4S, 4aS, 5aR, 12aS)-9-(2-(tert-butylamino)acetamido)-7-(dimethylamino)-3, 10, 12, 12a-tetrahydroxy-4-(methyl(nitroso)amino)-1, 11-dioxo-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydrotetracene-2-carboxamide

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=C(C1=C(O)[C@@H](N(C)N=O)[C@@](C[C@@]2([H])C(C(C3=C(O)C(NC(CNC(C)(C)C)=O)=CC(N(C)C)=C3C2)=O)=C4O)([H])[C@@]4(O)C1=O)N

InChI

InChI=1S/C28H36N6O9/c1-27(2,3)30-10-16(35)31-14-9-15(33(4)5)12-7-11-8-13-20(34(6)32-43)23(38)19(26(29)41)25(40)28(13,42)24(39)17(11)22(37)18(12)21(14)36/h9,11,13,20,30,36,38-39,42H,7-8,10H2,1-6H3,(H2,29,41)(H,31,35)/t11-,13-,20-,28-/m0/s1

Description

N-Nitroso Desmethyl Tigecycline 2 is an N-nitroso derivative of the secondary amine present in Tigecycline | 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 Tigecycline 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.