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PHR1049

Supelco

Gabapentin

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
1-(Aminomethyl)-cyclohexaneacetic acid, Neurontin
Empirical Formula (Hill Notation):
C9H17NO2
CAS Number:
Molecular Weight:
171.24
Beilstein:
2359739
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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This Item
Y0001280G1541287303
Gabapentin Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1049

Gabapentin

Gabapentin European Pharmacopoeia (EP) Reference Standard

Y0001280

Gabapentin

Gabapentin solid

Sigma-Aldrich

G154

Gabapentin

Gabapentin United States Pharmacopeia (USP) Reference Standard

USP

1287303

Gabapentin

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

pharmaceutical (small molecule)

format

neat

format

neat

format

-

format

neat

storage temp.

2-30°C

storage temp.

2-8°C

storage temp.

-

storage temp.

-

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

-

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, EP (PhEur) 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 LRAb7794 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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.

related product

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Validated HPLC method for the determination of gabapentin in human plasma using pre-column derivatization with 1-fluoro-2, 4-dinitrobenzene and its application to a pharmacokinetic study
Jalalizadeh H, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 854, 43-47 (2007)
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)
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)
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)

Articles

High-performance liquid chromatographic (HPLC) determination of gabapentin and related substances according to Ph. Eur monograph using Purospher® STAR RP-18 endcapped column, 250 x 4.6 mm, 5 μm.

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