PHR1044

Ciprofloxacin HCl

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Ciprofloxacin hydrochloride monohydrate
• Empirical Formula (Hill Notation): C₁₇H₁₈FN₃O₃ · HCl · H₂O
• CAS Number: 86393-32-0
• Molecular Weight: 385.82
• MDL number: MFCD00242856
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823074
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 929; traceable to Ph. Eur. C2190000; traceable to USP 1134335
• API family: ciprofloxacin
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• 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

Description

General description

Ciprofloxacin HCl is a fluoroquinolone antibiotic agent, which shows a broad spectrum of antibacterial activity against gram positive and gram negative bacteria.[1]

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.[2]

Application

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.[3] 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).[1]

Ciprofloxacin HCl may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and biological fluids[4] by chromatography[5][6] and chemiluminescence detection.[4]

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable