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PHR1049

Gabapentin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

1-(Aminomethyl)-cyclohexaneacetic acid, Neurontin

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About This Item

Empirical Formula (Hill Notation):
C9H17NO2
CAS Number:
60142-96-3
Molecular Weight:
171.24
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823079
EC Number:
262-076-3
Beilstein/REAXYS Number:
2359739
MDL number:
MFCD00865286
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1287303

API family

gabapentin

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

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)

InChI key

UGJMXCAKCUNAIE-UHFFFAOYSA-N

Gene Information

human ... CACNA1A(773), CACNA1B(774), CACNA1C(775), CACNA1D(776), CACNA1E(777), CACNA1F(778), CACNA1G(8913), CACNA1H(8912), CACNA1I(8911), CACNA1S(779), CACNA2D1(781), CACNA2D2(9254), CACNA2D3(55799), CACNA2D4(93589), CACNB1(782), CACNB2(783), CACNB3(784), CACNB4(785), CACNG1(786), CACNG2(10369), CACNG3(10368), CACNG4(27092), CACNG5(27091), CACNG6(59285), CACNG7(59284), CACNG8(59283)

General description

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.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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 LRAb7794 in the slot below. This is an example certificate only and may not be the lot that you receive.

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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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Articles

Gabapentin Assay: Ph. Eur. Monograph

LC-MS/MS quantitative method analyzes highly polar 11 nucleotide activated sugars using Supel™ Carbon LC column.

Colorimetric determination of gabapentin in pharmaceutical formulation
Abdellatef HE and Khalil HM
Journal of Pharmaceutical and Biomedical Analysis, 31(1), 209-214 (2003)
Veterinary Pharmacology and Therapeutics (2009)
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)
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1049-1G04061834413387