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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-Minocycline-2

● Under Development

Catalogue No.:	VE0014241
CAS No.:	N/A
Mol. Formula:	C22H24N4O8
Mol. Weight:	472.4 g/mol

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Additional information on N-Nitroso-Desmethyl-Minocycline-2

Parent drug

Minocycline

IUPAC Name

(4S,4aS,5aR,12aS)-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

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=CC(N(C)C)=C3C2)=O)=C4O)([H])[C@@]4(O)C1=O)N

Pharmacopeial Synonyms

N/A

InChI

InChI=1S/C22H24N4O8/c1-25(2)11-4-5-12(27)14-9(11)6-8-7-10-16(26(3)24-34)18(29)15(21(23)32)20(31)22(10,33)19(30)13(8)17(14)28/h4-5,8,10,16,27,29-30,33H,6-7H2,1-3H3,(H2,23,32)/t8-,10-,16-,22-/m0/s1

FDA Potency Category 3 NDSRI

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

Pharmacopoeial Synonyms

N/A

Inchl

InChI=1S/C22H24N4O8/c1-25(2)11-4-5-12(27)14-9(11)6-8-7-10-16(26(3)24-34)18(29)15(21(23)32)20(31)22(10,33)19(30)13(8)17(14)28/h4-5,8,10,16,27,29-30,33H,6-7H2,1-3H3,(H2,23,32)/t8-,10-,16-,22-/m0/s1

Description

N-Nitroso-Desmethyl-Minocycline-2 is a nitrosamine impurity associated with the tetracycline antibiotic minocycline, arising plausibly through nitrosative conversion of a demethylated precursor during synthesis, storage, or exposure to nitrite-containing media. With molecular formula C22H24N4O8 and molecular weight 472.4 g/mol, it combines the minocycline scaffold with an N-nitroso functionality, a structural alert for potential genotoxicity under ICH M7 risk principles. Its characterization commonly requires LC-MS/MS with accurate-mass confirmation, and orthogonal LC-UV or HRMS methods, because low-level occurrence and matrix effects can complicate trace determination.