PHR1697

Levofloxacin Hemihydrate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Levofloxacin hemihydrate
• Empirical Formula (Hill Notation): C₁₈H₂₀FN₃O₄ · 0.5H₂O
• CAS Number: 138199-71-0
• Molecular Weight: 370.38
• MDL number: MFCD07772024
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823561
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1362103
• API family: levofloxacin
• 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.: 2-30°C
• SMILES string: O.C[C@H]1COc2c(N3CCN(C)CC3)c(F)cc4C(=O)C(=CN1c24)C(O)=O.C[C@H]5COc6c(N7CCN(C)CC7)c(F)cc8C(=O)C(=CN5c68)C(O)=O
• InChI: 1S/2C18H20FN3O4.H2O/c2*1-10-9-26-17-14-11(16(23)12(18(24)25)8-22(10)14)7-13(19)15(17)21-5-3-20(2)4-6-21;/h2*7-8,10H,3-6,9H2,1-2H3,(H,24,25);1H2/t2*10-;/m00./s1
• InChI key: SUIQUYDRLGGZOL-RCWTXCDDSA-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.
Levofloxacin Hemihydrate is a third generation fluoroquinolone antibiotic that is known to inhibit the replication of bacterial DNA by interfering in the activity of DNA gyrase (topoisomerase II) and also during bacterial growth and reproduction.

Application

Levofloxacin Hemihydrate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography and spectrophotometric techniques.

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 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 LRAC2693 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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Safety Information

• Pictograms: GHS07,GHS08
• Signal Word: Danger
• Hazard Statements: H302 - H317 - H334
• Precautionary Statements: P261 - P264 - P272 - P280 - P301 + P312 - P302 + P352
• Hazard Classifications: Acute Tox. 4 Oral - Resp. Sens. 1 - Skin Sens. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable