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Key Documents

PHR1033

Supelco

Niacinamide

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Nicotinamide, Niacinamide, Nicotinic acid amide, Pyridine-3-carboxylic acid amide, Vitamin B3, Vitamin PP

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About This Item

Empirical Formula (Hill Notation):
C6H6N2O
CAS Number:
Molecular Weight:
122.12
Beilstein/REAXYS Number:
383619
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to BP 460
traceable to Ph. Eur. N0600000
traceable to USP 1462006

API family

nicotinamide

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

128-131 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

NC(=O)c1cccnc1

InChI

1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)

InChI key

DFPAKSUCGFBDDF-UHFFFAOYSA-N

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Niacinamide may be used as a pharmaceutical reference standard for the determination of the analyte in plasma, pharmaceutical formulations and infant/Adult nutritional formula powder by various chromatography methods.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Nicotinamide is an amide derivative of vitamin B3 and a PARP inhibitor
Niacinamide/Nicotinamide is an amide derivative of vitamin B3 and a PARP inhibitor

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC1697 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Eye Irrit. 2

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

flash_point_f

302.0 °F - closed cup

flash_point_c

150 °C - closed cup


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Certificates of Analysis (COA)

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Rapid determination of thiamine, riboflavin, niacinamide, pantothenic acid, pyridoxine, folic acid and ascorbic acid in Vitamins with Minerals Tablets by high-performance liquid chromatography with diode array detector
Jin P, et al.
Journal of Pharmaceutical and Biomedical Analysis, 70(5), 151-157 (2012)
Simultaneous determination of water-soluble vitamins in SRM 1849 Infant/Adult Nutritional Formula powder by liquid chromatography--isotope dilution mass spectrometry
Goldschmidt RJ and Wolf WR
Analytical and Bioanalytical Chemistry, 397(2), 471-481 (2010)
P Pfuhl et al.
Journal of pharmaceutical and biomedical analysis, 36(5), 1045-1052 (2004-12-29)
A sensitive, specific, accurate, and reproducible HPLC/MS-method for the simultaneous quantitative determination of niacin (NA) and its main metabolites niacinamide (NAM) and nicotinuric acid (NUR) in human plasma using chinolin-3-carboxylic acid as an internal standard was developed and validated according
Mitchell E Horwitz et al.
The Journal of clinical investigation, 124(7), 3121-3128 (2014-06-10)
Delayed hematopoietic recovery is a major drawback of umbilical cord blood (UCB) transplantation. Transplantation of ex vivo-expanded UCB shortens time to hematopoietic recovery, but long-term, robust engraftment by the expanded unit has yet to be demonstrated. We tested the hypothesis
Ann-Lii Cheng et al.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 31(32), 4067-4075 (2013-10-02)
Open-label, phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer. Patients were stratified and randomly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day. Primary end point

Articles

Pyridoxine hydrochloride, ≥98% (HPLC); Nicotinamide, ≥98.5% (HPLC); Thiamine hydrochloride, reagent grade, ≥99% (HPLC); Biotin, ≥99.0% (T); Folic acid, analytical standard; Cyanocobalamin (B12), analytical standard; Riboflavin (B2), analytical standard

Protocols

Separation of Pyridoxine; Nicotinamide; Nicotinic acid; Folic acid; (−)-Riboflavin, meets USP testing specifications; L-Ascorbic acid

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