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PHR1697

Levofloxacin Hemihydrate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Levofloxacin hemihydrate

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About This Item

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

300

grade

certified reference material, pharmaceutical secondary standard

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

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 and EP primary standards, where they are available.

Other Notes

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.
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.
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.

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pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Oral - Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

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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Q-Absorbance ratio spectrophotometric method for the simultaneous estimation of Cefpodoxime Proxetil and Levofloxacin Hemihydrate in their combined dosage form.
Kavar RC, et al.
International bulletin of drug research, 2(3), 22-30 (2012)
A novel isocratic RP-HPLC method development and validation for estimation of 5HMF in Levofloxacin Hemihydrate intravenous infusion.
Lakka NS and Goswami N
International Journal of Research in Pharmaceutical Sciences, 2(1), 45-51 (2011)
Quantitative determination of levofloxacin and ambroxol hydrochloride in pharmaceutical dosage form by reversed-phase high performance liquid chromatography.
Kothekar M K, et al.
Eurasian Journal of Analytical Chemistry, 2(1), 21-31 (2007)

Global Trade Item Number

SKUGTIN
PHR1697-1G04061834801788