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PHR1447

Levetiracetam

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Levetiracetam, (αS)-α-Ethyl-2-oxo-1-pyrrolidineacetamide, 2(S)-(2-Oxopyrrolidin-1-yl)butyramide

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About This Item

Empirical Formula (Hill Notation):
C8H14N2O2
CAS Number:
102767-28-2
Molecular Weight:
170.21
MDL number:
MFCD03265610
UNSPSC Code:
41116107
PubChem Substance ID:
329822607
NACRES:
NA.24

Key Documents

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001253
traceable to USP 1359404

API family

levetiracetam

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.

2-8°C

SMILES string

CC[C@H](N1CCCC1=O)C(N)=O

InChI

1S/C8H14N2O2/c1-2-6(8(9)12)10-5-3-4-7(10)11/h6H,2-5H2,1H3,(H2,9,12)/t6-/m0/s1

InChI key

HPHUVLMMVZITSG-LURJTMIESA-N

Gene Information

human ... CACNA1B(774), SV2A(9900)

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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.
Levitiracetam, an analog of piracetam, is an antiepileptic drug widely used for the remedy of epileptic seizures, partial as well as generalized epilepsy.

Application

Levitiracetam may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques and spectrofluorimetric technique.
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.

Biochem/physiol Actions

Levetiracetam is a pyrrolidine with antiepileptic activity.
Levetiracetam is a pyrrolidine with antiepileptic activity. Stereoselective binding of levetiracetam was confined to synaptic plasma membranes in the central nervous system with no binding occurring in peripheral tissue. Levetiracetam inhibits burst firing without affecting normal neuronal excitability, which suggests that it may selectively prevent hyper-synchronization of epileptiform burst firing and propagation of seizure activity.

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 LRAA2824 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

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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Reversed-phase HPLC analysis of levetiracetam in tablets using monolithic and conventional C18 silica columns.
Can NO and Arli G
Journal of AOAC (Association of Official Analytical Chemists) International, 93(4), 1077-1085 (2010)
Development and validation of stability-indicating HPTLC method for determination of levetiracetam in pharmaceutical dosage form.
Gandhi SV, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 6(5), 121-125 (2014)
Determination of levetiracetam in human plasma by liquid chromatography/electrospray tandem mass spectrometry and its application to bioequivalence studies.
Jain DS, et al.
Rapid Communications in Mass Spectrometry, 20(17), 2539-2547 (2006)
Spectrofluorimetric determination of topiramate and levetiracetam as single components in tablet formulations and in human plasma and simultaneous fourth derivative synchronous fluorescence determination of their co-adminstered mixture in human plasma.
El-Yazbi AF, et al.
Journal of Fluorescence, 26(4), 1225-1238 (2016)
Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulations
Hadad G, et al.
Acta pharmaceutica, 61(4), 377-389 (2011)
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