N-Methylol Rifampicin

● Under Development

Catalogue No.:	VE0026225
CAS No.:	N/A
Mol. Formula:	C44H60N4O13
Mol. Weight:	852.97 g/mol

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Additional information on

Parent drug

Rifampicin

IUPAC Name

N-Methylol Rifampicin

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

InChI=1S/C44H60N4O13/c1-22-12-11-13-23(2)43(57)48(21-49)34-29(20-45-47-17-15-46(9)16-18-47)38(54)31-32(39(34)55)37(53)27(6)41-33(31)42(56)44(8,61-41)59-19-14-30(58-10)24(3)40(60-28(7)50)26(5)36(52)25(4)35(22)51/h11-14,19-20,22,24-26,30,35-36,40,49,51-55H,15-18,21H2,1-10H3/b12-11+,19-14+,23-13-,45-20+/t22-,24+,25+,26+,30-,35-,36+,40+,44-/m0/s1

InChI

Description

N-Methylol Rifampicin is an identified process and degradation impurity arising from hydroxymethylation of the rifampicin core. It exhibits distinct chromatographic behavior with a slightly increased polarity versus the parent drug and is routinely monitored by stability-indicating HPLC coupled with mass spectrometry and 1H NMR for confirmation. Formation is promoted by exposure to formaldehyde donors, aqueous alkaline conditions, or elevated temperatures and can alter assay results and impurity profiles if uncontrolled. Accurate quantification and characterization are critical for specification setting, risk assessment and development of mitigation measures such as optimized synthesis, strict solvent control and appropriate packaging to ensure pharmaceutical quality and regulatory compliance.