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Key Documents

PHR1322

Supelco

Gabapentin Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

4,4-Pentamethylene-2-pyrrolidinone, 4,4-PENTAMETHYLENE-2-PYRROLIDONE, Gabapentin Impurity A, 3-Azaspiro[4.5]decan-2-one

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About This Item

Formule empirique (notation de Hill):
C9H15NO
Numéro CAS:
Poids moléculaire :
153.22
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 Ph. Eur. Y0001281
traceable to USP 1287325

Famille d'API

gabapentin

CofA (certificat d'analyse)

current certificate can be downloaded

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Pf

84-89 °C (lit.)

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-8°C

Chaîne SMILES 

O=C1CC2(CCCCC2)CN1

InChI

1S/C9H15NO/c11-8-6-9(7-10-8)4-2-1-3-5-9/h1-7H2,(H,10,11)

Clé InChI

JAWPQJDOQPSNIQ-UHFFFAOYSA-N

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Description générale

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.

Application

Gabapentin Related Compound A may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high performance liquid chromatography (HPLC).
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 LRAC4059 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

Development and validation of a stability-indicating RP-HPLC-CAD method for gabapentin and its related impurities in presence of degradation products
Ragham PK and Chandrasekhar KB
Journal of Pharmaceutical and Biomedical Analysis, 125, 122-129 (2016)
Dennis F Thompson et al.
The Annals of pharmacotherapy, 47(6), 897-903 (2013-05-16)
To determine whether gabapentin is effective in the treatment of persistent or intractable hiccups. A search of MEDLINE (1966-March 2013) using the MeSH search terms gabapentin, hiccups, and hiccups/drug therapy was performed. Additional databases searched included Web of Science (1945-March
Benjamin Beal et al.
Clinical interventions in aging, 7, 249-255 (2012-08-07)
Post-herpetic neuralgia is a neuropathic pain syndrome resulting from an insult to the peripheral and central nervous systems caused by the varicella zoster virus. Spontaneous pain may result in the persistent sensation of burning, tingling, or aching and may be
Cuiping Chen et al.
Journal of pharmaceutical sciences, 102(4), 1155-1164 (2013-02-06)
Neurontin®, an immediate-release (IR) formulation of gabapentin, was the first drug approved by the United States Food and Drug Administration for the treatment of postherpetic neuralgia (PHN). The effective dosing regimen of gabapentin IR (G-IR) for PHN is 1800 mg/day in
Nada Alayed et al.
Obstetrics and gynecology, 123(6), 1221-1229 (2014-05-09)
To examine the evidence of preemptive use of gabapentin in abdominal hysterectomy. We conducted an electronic based search using the following databases: PubMed, EMBASE, Ovid MEDLINE, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials. The following medical subject heading terms

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