Niacinamide, also known as Nicotinamide, is a water-soluble form of Vitamin B3 and an established pharmaceutical and nutritional active ingredient. It is a naturally occurring amide form of vitamin B3 and differs chemically and pharmacologically from nicotinic acid (niacin).
Niacinamide is widely used in pharmaceutical formulations, nutritional products, dietary supplements, topical preparations and research applications. It is an important precursor of the coenzymes NAD and NADP, which participate in numerous cellular oxidation-reduction and metabolic processes.
The USP-NF recognizes Niacinamide as an official substance with the chemical formula C6H6N2O and a molecular weight of 122.12 g/mol.
Niacinamide is a well-established Vitamin B3 pharmaceutical ingredient used in the development and manufacture of pharmaceutical, nutritional and healthcare formulations.
Its established compendial status makes control of identity, assay, loss on drying, residue on ignition and other applicable quality characteristics important for pharmaceutical-grade material.
Important quality attributes include:
Product Name: Niacinamide
Synonyms: Nicotinamide; 3-Pyridinecarboxamide; Vitamin B3; Vitamin PP
CAS Number: 98-92-0
Molecular Formula: C6H6N2O
Molecular Weight: 122.12 g/mol
IUPAC Name: Pyridine-3-carboxamide
Drug / Ingredient Class: Vitamin B3 / Nicotinamide
Therapeutic Class: Vitamin Supplement / Nutritional Agent
Therapeutic Area: Nutritional and Metabolic Health
Molecule Type: Synthetic Small Molecule
NIST and FDA/NIH GSRS records confirm the CAS number, molecular formula and molecular weight.
Niacinamide is a precursor of nicotinamide adenine dinucleotide (NAD) and related coenzymes that are essential for cellular energy metabolism and numerous enzymatic reactions.
Its biological relevance includes:
Niacinamide API is relevant to:
Niacinamide is an established source of vitamin B3 and can be incorporated into nutritional and dietary formulations.
It is used in products designed to provide or supplement niacin equivalents. Unlike nicotinic acid, niacinamide generally does not produce the characteristic flushing associated with pharmacological doses of nicotinic acid.
Niacinamide is also widely studied and used in topical preparations for skin-care and dermatological applications.
It is relevant to research involving:
Topical applications should be described according to the applicable cosmetic or pharmaceutical regulatory framework for the intended market.
Niacinamide occurs as a white crystalline powder. The Food Chemicals Codex describes it as a white crystalline powder and reports that it is readily soluble in water and soluble in alcohol and glycerin.
The USP monograph specifies a melting range of 128–131°C and a loss on drying of not more than 0.5%.
Niacinamide is highly water-soluble compared with many pharmaceutical active ingredients.
The Food Chemicals Codex describes approximately:
These values are useful descriptive reference data, while actual solubility can vary with temperature, solvent grade and test conditions.
A controlled Niacinamide manufacturing process may involve:
The exact commercial synthesis route should be based on the manufacturer's validated manufacturing process and applicable regulatory documentation.
Typical pharmaceutical-grade Niacinamide testing may include:
The USP monograph provides specific identification, assay, residue-on-ignition, readily-carbonizable-substances and melting-range requirements.
The USP-NF monograph specifies that Niacinamide contains not less than 98.5% and not more than 101.5% of C6H6N2O, calculated on the dried basis.
This is a verified compendial numerical value and is therefore appropriate for the CMS specification when the product is being represented against the applicable USP-NF standard.
The USP monograph specifies loss on drying NMT 0.5%. The prescribed USP test involves drying over silica gel for four hours.
The USP monograph specifies residue on ignition NMT 0.1%.
Historical USP editions specify a heavy-metals limit, while modern pharmaceutical quality systems generally address elemental impurities through applicable compendial requirements and ICH Q3D principles.
For a current commercial API specification, the manufacturer's approved elemental-impurity specification should therefore be followed rather than automatically transferring an obsolete heavy-metals test.
The USP monograph specifies a melting range of 128–131°C.
Niacinamide should be preserved in tight containers and protected from unsuitable environmental conditions.
For commercial API storage, the final temperature, humidity and packaging requirements should be established according to validated stability data and the applicable manufacturer's specification. The USP monograph specifies preservation in tight containers.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5% – 101.5% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |
| Melting Point | 128–131°C |