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PHR1044

Supelco

Ciprofloxacin HCl

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Ciprofloxacin hydrochloride monohydrate
Empirical Formula (Hill Notation):
C17H18FN3O3 · HCl · H2O
CAS Number:
Molecular Weight:
385.82
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 929
traceable to PhEur C2190000
traceable to USP 1134335

storage temp.

2-30°C

SMILES string

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

InChI

1S/C17H18FN3O3.ClH.H2O/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);1H;1H2

InChI key

ARPUHYJMCVWYCZ-UHFFFAOYSA-N

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General description

Ciprofloxacin HCl is a fluoroquinolone antibiotic agent, which shows a broad spectrum of antibacterial activity against gram positive and gram negative bacteria.
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.
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.

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 HCl has been used as a test compound in combination with the high-throughput nanowell antibiotic susceptibility testing device to validate its effectiveness as an antibacterial agent, thereby preventing the growth of bacteria. It may also be used as a standard in the determination of ciprofloxacin HCl in pharmaceutical preparations and serum samples using reversed-phase high performance liquid chromatography (RP-HPLC).
Ciprofloxacin HCl may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and biological fluids by chromatography and chemiluminescence detection.

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 LRAB3671 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Simultaneous determination of ciprofloxacin hydrochloride and dexamethasone sodium phosphate in eye drops by HPLC
Katakam P and Sireesha KR
Journal of Chemistry, 9(3), 1077-1084 (2012)
Chemiluminescence determination of some fluoroquinolone derivatives in pharmaceutical formulations and biological fluids using [Ru (bipy)32+]-Ce (IV) system
Aly FA, et al.
Talanta, 53(4), 885-893 (2001)
Sensitive LC determination of ciprofloxacin in pharmaceutical preparations and biological fluids with fluorescence detection
Zotou A and Miltiadou N
Journal of Pharmaceutical and Biomedical Analysis, 28, 559-568 (2002)
Quantitation of Ciprofloxacin Hydrochloride and Norfloxacin in Tablets Using High-Performance Liquid Chromatography
Parasrampuria J and Gupta VD
Drug Development and Industrial Pharmacy, 16(9), 1597-1604 (1990)
Bacterial nanoscale cultures for phenotypic multiplexed antibiotic susceptibility testing
Weibull E, et al.
Journal of Clinical Microbiology, 52(9), 3310- 3317 (2014)

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