Nicotinamide, also known as Niacinamide, is the amide form of vitamin B3 and a water-soluble vitamin compound used in pharmaceutical, nutraceutical and nutritional formulations. It is an important precursor of the coenzymes NAD and NADP, which participate in numerous cellular oxidation-reduction and metabolic processes.
Nicotinamide is a well-established pharmaceutical ingredient with a defined chemical structure and established pharmacopoeial quality standards.
Nicotinamide is used as an active pharmaceutical ingredient and nutritional ingredient in the development and manufacture of vitamin B3-containing pharmaceutical and nutraceutical products.
Important quality attributes include identity, assay, related substances, loss on drying, sulfated ash, melting range and heavy-metal/elemental impurity control.
CAS Number: 98-92-0
Molecular Formula: C6H6N2O
Molecular Weight: 122.12 g/mol
IUPAC Name: Pyridine-3-carboxamide
Synonyms: Niacinamide, Nicotinamide
Drug / Ingredient Class: Vitamin B3
Therapeutic Area: Nutritional / Metabolic
Molecule Type: Small-Molecule Organic Compound
Nicotinamide is listed with CAS 98-92-0, formula C6H6N2O and molecular weight approximately 122.12 g/mol.
Nicotinamide serves as a precursor for the biosynthesis of nicotinamide adenine dinucleotide (NAD+) and related coenzymes. NAD-dependent enzymes participate in energy metabolism, cellular oxidation-reduction reactions and numerous enzymatic processes.
Unlike nicotinic acid, nicotinamide does not produce the characteristic flushing response associated with pharmacological doses of niacin.
Nicotinamide API is used in:
Nicotinamide is a white crystalline powder or crystals. It is readily soluble in water and has a characteristic melting range of approximately 128–131°C according to pharmacopoeial references.
A controlled Nicotinamide manufacturing process may involve:
Typical Nicotinamide quality-control testing includes:
The BP 2025 monograph specifies loss on drying NMT 0.5% and sulfated ash NMT 0.1%. It also establishes limits for unspecified impurities and total impurities.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0% – 101.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 30 ppm |
| pH (1% Solution) | 6.0 – 8.0 |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.20% |
| Melting Point | 128 – 131°C |