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Nicotinamide mononucleotide

Compositional guideline for Nicotinamide mononucleotide permitted for use in listed medicines.

Description

Nicotinamide mononucleotide (NMN) is a metabolite of nicotinamide, a component of vitamin B3 (i.e. niacin). The ingredient is produced by enzymatic synthetic process from D-ribose, nicotinamide, and sodium hexametaphosphate in the presence of enzymes produced by genetically modified Escherichia coli BL21. The reaction product is then purified by column chromatography to completely remove residual enzymes. The ingredient is stereospecific to the β-anomer.

Molecular Formula: C11H15N2O8P

CAS number: 1094-61-7

Molecular weight: 334.22

Chemical structure:

Nicotinamide mononucleotide

Test

Method reference

Acceptance criteria

CHARACTERISATION
General properties
AppearanceVisualWhite to off-white powder
Water contentUSP <921>≤1%
pHUSP <791>2.0-4.0
Identity
FT-IRUSP <854>Observation of characteristic peaks at 3439, 3321, 1672, 1576, 1124 cm-¹.
HPLC-UVHPLC-UV[1]HPLC retention time of main peak should correspond to that of the reference standard
NMRUSP<761>Recorded NMR spectra must be in full agreement with the structure of NMN[2].
MSUSP<736>Observation of molecular ion peak at m/z 335 [M+H]+.
UV-VisUSP <857>Observation of peaks at 210 and 264 nm.
Assay
HPLC-UVHPLC-UV[1]98.0-102.0%
Impurities and incidental constituents
Residual Solvents
EthanolUSP<467>≤1000 ppm
Elemental impurities
ArsenicUSP <730><0.5 ppm
LeadUSP<730><0.5 ppm
MercuryUSP<730><0.3 ppm
CadmiumUSP<730><0.5 ppm
Other organic impurities
Nicotinamide ribosideHPLC-UV[1]≤0.2%
NiacinHPLC-UV[1]≤0.1%
NicotinamideHPLC-UV[1]≤0.2%
Other largest single impurityHPLC-UV[1]≤0.1%
Total impuritiesHPLC-UV[1]≤1.0%
Microbiology 

Total Aerobic Microbial

Count

USP<61><750 CFU/g
Yeast and MoldUSP<61><25 CFU/g
Escherichia coliUSP<62>Absent 
SalmonellaUSP<62>Absent
Staphylococcus aureusUSP<62>Absent

Footnotes

1. HPLC-UV: Column: Athena CNW C18-WP, 250 × 4.6 mm × 5 um; Flow rate: 0.7 mL/min; Column temperature: 28 °C; Mobile phase A: Sodium dihydrogen phosphate solution (0.35% w/v, pH adjusted to 3.0-3.1 with phosphoric acid);Mobile phase B: Methanol; Chromatographic mode: Gradient; Detector wavelength: 254 nm; Retention time: Nicotinamide mononucleotide (4.9 min), Nicotinamide riboside (5.5 min), Niacin (7.8 min), and Nicotinamide (11.4 min).

2. 1H NMR (D2O): δH 9.32 (1H, s), 9.14 (1H, d, J = 6.4 Hz), 8.84 (1H, d, J = 8.4 Hz), 8.15 (1H, t, J = 7.2 Hz), 6.07 (1H, d, J = 5.2 Hz), 4.50 (1H, br s), 4.42 (1H, t, J = 5.2 Hz), 4.30 (1H, q, J = 2.5 Hz), 4.16 (1H, m), 4.00 (1H, m).

Abbreviations

  • br = Broad
  • CAS = Chemical Abstract Services
  • CFU = Colony Forming Unit
  • FT-IR = Fourier Transform - Infrared Spectroscopy
  • HPLC = High Performance Liquid Chromatography
  • MS = Mass Spectrometry
  • NMR = Nuclear Magnetic Resonance
  • USP = United States Pharmacopeia
  • UV = Ultraviolet
  • Vis = Visible
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