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Merck
CN

PHR1322

Supelco

Gabapentin Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(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

Empirical Formula (Hill Notation):
C9H15NO
CAS Number:
64744-50-9
Molecular Weight:
153.22
MDL number:
MFCD00177938
UNSPSC Code:
41116107
PubChem Substance ID:
329823307
NACRES:
NA.24

Key Documents

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001281
traceable to USP 1287325

API family

gabapentin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

84-89 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

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)

InChI key

JAWPQJDOQPSNIQ-UHFFFAOYSA-N

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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.

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.

Analysis Note

These secondary standards offer multi-traceability to the US 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 LRAC4059 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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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)
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
Ankesh Kukkar et al.
Archives of pharmacal research, 36(3), 237-251 (2013-02-26)
Gabapentin is an anti-epileptic agent but now it is also recommended as first line agent in neuropathic pain, particularly in diabetic neuropathy and post herpetic neuralgia. α2δ-1, an auxillary subunit of voltage gated calcium channels, has been documented as its
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
Kim Abbass
The Annals of pharmacotherapy, 46(12), 1707-1711 (2012-12-13)
To evaluate the effectiveness of gabapentin in adults with phantom limb pain. A PubMed search (1966-September 2012) was conducted using the key words phantom limb pain and gabapentin. Search limits were English language, humans, adult, clinical trials, and randomized controlled
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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.

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