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Key Documents

PHR1049

Supelco

Gabapentin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

1-(Aminomethyl)-cyclohexaneacetic acid, Neurontin

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About This Item

Formule empirique (notation de Hill):
C9H17NO2
Numéro CAS:
Poids moléculaire :
171.24
Numéro Beilstein :
2359739
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to USP 1287303

Famille d'API

gabapentin

CofA (certificat d'analyse)

current certificate can be downloaded

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

NCC1(CC(O)=O)CCCCC1

InChI

1S/C9H17NO2/c10-7-9(6-8(11)12)4-2-1-3-5-9/h1-7,10H2,(H,11,12)

Clé InChI

UGJMXCAKCUNAIE-UHFFFAOYSA-N

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Description générale

Gabapentin is an antiepileptic drug, which is a structural analog of γ-aminobu-tyric acid (GABA). It is used in the treatment of partial seizures in adults and children.
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. Gabapentin is an anti-convulsant drug, which leads to the irreversible inhibition of the enzyme GABA-transaminase, thereby also prevents the physiological degradation of GABA in the brain.

Application

Gabapentin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography, colorimetry and spectrophotometry.
Gabapentin may be used as a reference standard to validate the amount gabapentin present in the following:
  • In human plasma samples using high performance liquid chromatography (HPLC).
  • In pharmaceutical formulations using isocratic reversed-phase high performance liquid chromatography (RP-HPLC).
Gabapentin may be used pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric 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.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAb7794 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

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.

Produit(s) apparenté(s)

Réf. du produit
Description
Tarif

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

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Consulter la Bibliothèque de documents

Colorimetric determination of gabapentin in pharmaceutical formulation
Abdellatef HE and Khalil HM
Journal of Pharmaceutical and Biomedical Analysis, 31(1), 209-214 (2003)
Comparison of two aerosol-based detectors for the analysis of gabapentin in pharmaceutical formulations by hydrophilic interaction chromatography
Jia S, et al.
Talanta, 85(5), 2301-2306 (2011)
Veterinary Pharmacology and Therapeutics (2009)
Development and application of a validated HPLC method for the analysis of dissolution samples of gabapentin drug products
Gupta A, et al.
Journal of Pharmaceutical and Biomedical Analysis, 46, 181-186 (2008)
Spectrophotometric determination of gabapentin in pharmaceutical formulations using ninhydrin and p-acceptors
Siddiqui AF, et al.
European Journal of Medicinal Chemistry, 45(7), 2761-2767 (2010)

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