PHR1167

Supelco

Ciprofloxacin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Ciprobay, 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid
Empirical Formula (Hill Notation):
C17H18FN3O3
CAS Number:
Molecular Weight:
331.34
Beilstein/REAXYS Number:
3568352
MDL number:
PubChem Substance ID:

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur Y0000198
traceable to USP 1134313

SMILES string

OC(=O)C1=CN(C2CC2)c3cc(N4CCNCC4)c(F)cc3C1=O

InChI

1S/C17H18FN3O3/c18-13-7-11-14(8-15(13)20-5-3-19-4-6-20)21(10-1-2-10)9-12(16(11)22)17(23)24/h7-10,19H,1-6H2,(H,23,24)

InChI key

MYSWGUAQZAJSOK-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.
Ciprofloxacin is grouped under the class of second generation of quinolone analogs of nalidixic acid that exhibits high potency, minimal toxicity and a broad-spectrum antibacterial activity. It can be administered both parenterally and orally. It finds applications in the treatment of broad range of infections of the urinary tract, respiratory tract and gastrointestinal tract, as well as skin and soft tissue infections.

Application

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.
Ciprofloxacin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and serum samples by various chromatography techniques.

Analysis Note

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

Other Notes

Values of analytes vary lot to lot.
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 LRAA6508 in the slot below. This is an example certificate only and may not be the lot that you receive.

RIDADR

NONH for all modes of transport

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

The simultaneous separation and determination of five quinolone antibotics using isocratic reversed-phase HPLC: Application to stability studies on an ofloxacin tablet formulation
Shervington LA, et al.
Journal of Pharmaceutical and Biomedical Analysis, 39(3-4), 769-775 (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)
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)
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)
Florentia Kaguelidou et al.
The Pediatric infectious disease journal, 30(2), e29-e37 (2010-11-05)
ciprofloxacin has no marketing authorization for use in neonates worldwide but it is prescribed for the treatment of neonatal life-threatening infections, mainly in developing countries and in Europe. Given the concerns about its toxicity in this population and the necessity...

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