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Merck

PHR1191

Nitrofurantoin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

N-(5-Nitro-2-furfurylidene)-1-aminohydantoin, Furadoxyl, Nitrofurantoine

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About This Item

Empirical Formula (Hill Notation):
C8H6N4O5
CAS Number:
67-20-9
Molecular Weight:
238.16
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823199
EC Number:
200-646-5
Beilstein/REAXYS Number:
893207
MDL number:
MFCD00003224

Key Documents

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Product Name

Nitrofurantoin, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

NXFQHRVNIOXGAQ-YCRREMRBSA-N

InChI

1S/C8H6N4O5/c13-6-4-11(8(14)10-6)9-3-5-1-2-7(17-5)12(15)16/h1-3H,4H2,(H,10,13,14)/b9-3+

SMILES string

[O-][N+](=O)c1ccc(\C=N\N2CC(=O)NC2=O)o1

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1464001

API family

nitrofurantoin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

cleaning products
cosmetics
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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Analysis Note

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

Application

Nitrofurantoin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by voltammetry and chromatography techniques.
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.

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.
Nitrofurantoin, a synthetic, nitrofuran-derivative, is a widely used urinary antimicrobial compound that is effective against pulmonary fibrosis, neuropathy, hepatitis and hemolytic anemia.

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.
To see an example of a Certificate of Analysis for this material enter LRAA9007 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Oral - Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Detection of ampicillin contamination in nitrofurantoin preparations by high pressure liquid chromatography
Bracey A
Journal of Pharmaceutical Sciences, 62(10), 1695-1696 (1973)
Determination of nitrofurantoin drug in pharmaceutical formulation and biological fluids by square-wave cathodic adsorptive stripping voltammetry
Hammam E
Journal of Pharmaceutical and Biomedical Analysis, 30(3), 651-659 (2002)
Liquid chromatographic and spectrophotometric determination of phenazopyridine hydrochloride, ampicilline trihydrate, and nitrofurantoine in pharmaceutical preparations
Palabiyik IM and Onur F
Analytical Letters, 37(10), 2125-2150 (2004)
Stripping voltammetric behaviour of toxic drug nitrofurantoin
Jain R, et al.
Journal of Hazardous Materials, 169(1-3), 667-672 (2009)
Robin L P Jump et al.
Infection control and hospital epidemiology, 33(12), 1185-1192 (2012-11-13)
We introduced a long-term care facility (LTCF) infectious disease (ID) consultation service (LID service) that provides on-site consultations to residents of a Veterans Affairs (VA) LTCF. We determined the impact of the LID service on antimicrobial use and Clostridium difficile
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