PHR1614

Norfloxacin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Norfloxacin, 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-piperazino-3-quinolinecarboxylic acid
• Empirical Formula (Hill Notation): C₁₆H₁₈FN₃O₃
• CAS Number: 70458-96-7
• Molecular Weight: 319.33
• EC Number: 274-614-4
• MDL number: MFCD00079532
• PubChem Substance ID: 329823510
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 670; traceable to Ph. Eur. N1230000; traceable to USP 1471506
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: CCN1C=C(C(O)=O)C(=O)c2cc(F)c(cc12)N3CCNCC3
• InChI: 1S/C16H18FN3O3/c1-2-19-9-11(16(22)23)15(21)10-7-12(17)14(8-13(10)19)20-5-3-18-4-6-20/h7-9,18H,2-6H2,1H3,(H,22,23)
• InChI key: OGJPXUAPXNRGGI-UHFFFAOYSA-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.
Norfloxacin is a synthetic broad-spectrum antibacterial drug that is effective against various gram positive and gram negative bacteria. Its major application is in the treatment of urinary tract infections.

Application

Norfloxacin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and serum samples by high performance liquid chromatography (HPLC) and spectrophotometric 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.

Packaging

1 g

Biochem/physiol Actions

Norfloxacin blocks DNA replication by interfering with an ATP-induced structural transition of DNA complexed with DNA gyrase (topoisomerase).
Mode of action: inhibits bacterial DNA replication
Antimicrobial spectrum: Gram-negative bacteria; less effective against Gram-positive bacteria

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAC2802 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2