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PHR1322

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
NACRES:
NA.24
PubChem Substance ID:
329823307
UNSPSC Code:
41116107
MDL number:
MFCD00177938
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

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

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.

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Storage Class

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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Articles

Gabapentin Assay: Ph. Eur. Monograph

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

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)
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
Cuiping Chen et al.
Current clinical pharmacology, 8(1), 67-72 (2012-09-06)
Gabapentin is approved for the treatment of postherpetic neuralgia (PHN) and epilepsy. The pharmacokinetic (PK) properties of gabapentin, including absorption, distribution, metabolism, and excretion (ADME), were investigated during the development of Neurontin®, an immediate-release (IR) formulation of gabapentin that is
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1322-100MG04061834415930