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PHR1614

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Norfloxacin

Pharmaceutical Secondary Standard; Certified Reference Material

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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:
Molecular Weight:
319.33
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 670
traceable to Ph. Eur. N1230000
traceable to USP 1471506

API family

norfloxacin

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

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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.
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.

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.

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.

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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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Kinetic spectrophotometric method for the determination of norfloxacin in pharmaceutical formulations.
Rahman N, et al.
European Journal of Pharmaceutics and Biopharmaceutics, 57(2), 359-367 (2004)
Quantitative determination of ciprofloxacin and norfloxacin in pharmaceutical preparations by high performance liquid chromatography.
Kassab N, et al.
Brazilian Journal of Pharmaceutical Sciences , 41(4), 507-513 (2005)
Flow injection spectrophotometric and chromatographic determination of ciprofloxacin and norfloxacin in pharmaceutical formulations.
Al-Momani I, et al.
Journal of Flow Injection Analysis, 25(2), 151-151 (2008)
Direct determination of four fluoroquinolones, enoxacin, norfloxacin, ofloxacin, and ciprofloxacin, in pharmaceuticals and blood serum by HPLC.
Samanidou VF, et al.
Analytical and Bioanalytical Chemistry, 375(5), 623-629 (2003)

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