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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 Plazomicin 2

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Catalogue No.:	VE0014200
CAS No.:	N/A
Mol. Formula:	C25H46N8O12
Mol. Weight:	650.7 g/mol

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Additional information on N-Nitroso Plazomicin 2

FDA Potency Category 2 NDSRI

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

Parent drug

Plazomicin

IUPAC Name

(S)-4-amino-N-((1R, 2S, 3S, 4R, 5S)-5-amino-4-(((2S, 3R)-3-amino-6-(((2-hydroxyethyl)(nitroso)amino)methyl)-3, 4-dihydro-2H-pyran-2-yl)oxy)-2-(((2R, 3R, 4R, 5R)-3, 5-dihydroxy-5-methyl-4-(methyl(nitroso)amino)tetrahydro-2H-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=C(N[C@H]1[C@H](O[C@@H]2[C@H](O)[C@@H](N(C)N=O)[C@@](C)(O)CO2)[C@@H](O)[C@H](O[C@@H]3[C@H](N)CC=C(CN(CCO)N=O)O3)[C@@H](N)C1)[C@@H](O)CCN

InChI

InChI=1S/C25H46N8O12/c1-25(39)11-42-24(18(37)21(25)32(2)30-40)45-20-15(29-22(38)16(35)5-6-26)9-14(28)19(17(20)36)44-23-13(27)4-3-12(43-23)10-33(31-41)7-8-34/h3,13-21,23-24,34-37,39H,4-11,26-28H2,1-2H3,(H,29,38)/t13-,14+,15-,16+,17+,18-,19-,20+,21-,23-,24-,25+/m1/s1

Description

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