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Merck
CN

PHR1322

加巴喷丁相关物质A

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

3,3-环戊烷戊二酰亚胺

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关于此项目

经验公式(希尔记法):
C9H15NO
化学文摘社编号:
分子量:
153.22
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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InChI

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

SMILES string

O=C1CC2(CCCCC2)CN1

InChI key

JAWPQJDOQPSNIQ-UHFFFAOYSA-N

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

Quality Level

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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.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


分析证书(COA)

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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)
Charles E Argoff et al.
Expert opinion on drug delivery, 9(9), 1147-1160 (2012-07-20)
Gabapentin immediate-release formulations (G-IR) administered three times a day is an efficacious treatment for postherpetic neuralgia (PHN), but its potential benefits may not be fully realized due to tolerability issues as well as its pharmacokinetic (PK) properties such as its
Mustafa Zakkar et al.
Interactive cardiovascular and thoracic surgery, 17(4), 716-719 (2013-07-09)
A best evidence topic in cardiothoracic surgery was written according to a structured protocol. The question addressed was whether gabapentin, a commonly prescribed neuropathic analgesic and anticonvulsant, is safe and beneficial in patients with post-thoracotomy pain following thoracic surgery. Seventeen
Mattias Linde et al.
The Cochrane database of systematic reviews, 6(6), CD010609-CD010609 (2013-06-26)
Some antiepileptic drugs but not others are useful in clinical practice for the prophylaxis of migraine. This might be explained by the variety of actions of these drugs in the central nervous system. The present review is part of an
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

商品

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

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