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Biotin or D-Biotin or Bios II

CAS No.: 58-85-5
Molecular Weight: 244.32 g/mol
Chemical Formula C10H16N2O3S

Nicotinamide or Niacinamide or Nicotinic Amide or Pyridinecarboxamide or Vitamin B3 is used as a dietary supplement and medication. It has also been used in many topical agents including sunscreens and cosmetic agents.

General Properties and Specifications of Nicotinamide or Niacinamide or Nicotinic Amide or Pyridinecarboxamide or Vitamin B3:
Appearance: White crystalline powder.
Assay: 99.5% minimum.
Loss on drying: 0.2% maximum.
Heavy Metals (Pb): 0.003% maximum.
Nicotinic Acid: 0.2% maximum.
Suitability for Cell Culture: Passes test.
Bacterial Endotoxin Test (BET) (EU/mg = IU/mg): <0.05 EU/mg.
Relative density: about 1.40 @ 25C.
Auto-ignition temperature: 480C.
Melting Point: 128C - 131C.
Solubility: Soluble in water.
Storage: Room Temperature.


Niacinamide USP Grade Specifications:
C6H6N2O -- 122.12
3-Pyridinecarboxamide;
Nicotinamide CAS 98-92-0
UNII: 25X51I8RD4

DEFINITION
Niacinamide contains NLT 98.5% and NMT 101.5% of niacinamide (C6H6N2O), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption.
B. Ultraviolet Absorption.

Residue on Ignition: NMT 0.1%
Readily Carbonizable Substances:
Sample solution: Dissolve 200 mg of Niacinamide in 5 mL of sulfuric acid.
Acceptance criteria: The Sample solution has no more color than Matching Fluid A.
Melting Range or Temperature: 128C to 131C
Loss on Drying: Dry a sample over silica gel for 4 h: it loses NMT 0.5% of its weight.

Nicotinamide BP Ph Eur Grade Specifications:
C6H6N2O --- 122.1 CAS 98-92-0

DEFINITION
Pyridine-3-carboxamide.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals.
Solubility: Freely soluble in water and in anhydrous ethanol, slightly soluble in methylene chloride.

IDENTIFICATION
First identification: B.
Second identification: A, C
A. Melting point: 128C to 131C.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.

TESTS
Solution S: Dissolve 2.5 g in carbon dioxide-free water and dilute to 50 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than.
pH: 6.0 to 7.5 for solution S.
Related substances: To pass the test.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo for 18 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.


Niacinamide FCC Food Grade Specifications:
Nicotinamide
C6H6N2O Formula weight 122.13
CAS 98-92-0

DESCRIPTION
Niacinamide occurs as a white, crystalline powder. One gram dissolves in about 1 mL of water, in about 1.5 mL of alcohol, and in about 10 mL of glycerin. Its solutions are neutral to litmus.
Function: Nutrient.

REQUIREMENTS
Identification:
A. Transfer about 20 mg of sample into a 1000-mL volumetric flask, dissolve in and dilute to volume with water, mix, and determine the absorbance of the solution in a 1-cm cell at 245 nm and at 262 nm with a suitable pectrophotometer, using water as the blank. The ratio A245/A262 is 0.65 _ 0.02.
B. The infrared absorption spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at the same wavelengths as those of a similar preparation of USP Niacinamide Reference Standard.

Assay: Not less than 98.5% and not more than 101.0% of C6H6N2O after drying.
Lead: Not more than 2 mg/kg.
Loss on Drying: Not more than 0.5%.
Melting Range: Between 128C and 131C.
Readily Carbonizable Substances: Passes test.
Residue on Ignition: Not more than 0.1%.