PHR1191

Nitrofurantoin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): N-(5-Nitro-2-furfurylidene)-1-aminohydantoin, Furadoxyl, Nitrofurantoine
• Empirical Formula (Hill Notation): C₈H₆N₄O₅
• CAS Number: 67-20-9
• Molecular Weight: 238.16
• Beilstein: 893207
• EC Number: 200-646-5
• MDL number: MFCD00003224
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823199
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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
• SMILES string: [O-][N+](=O)c1ccc(\C=N\N2CC(=O)NC2=O)o1
• 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+
• InChI key: NXFQHRVNIOXGAQ-YCRREMRBSA-N

Description

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.[1][2]

Application

Nitrofurantoin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by voltammetry[1] and chromatography[3][4] 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.

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 LRAA9007 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Statements: H302,H317,H334
• Precautionary Statements: P280 - P301 + P312 + P330 - P302 + P352
• Hazard Classifications: Acute Tox. 4 Oral - Resp. Sens. 1 - Skin Sens. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable