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Merck
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Key Documents

PHR1584

Supelco

Donepezil Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Donepezil hydrochloride, (±)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone hydrochloride, 2,3-Dihydro-5,6-dimethoxy-2-{[1-(phenylmethyl)-4-piperidinyl]methyl}-1H-inden-1-one

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About This Item

Fórmula empírica (notación de Hill):
C24H29NO3 · HCl
Número de CAS:
Peso molecular:
415.95
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to USP 1224981

API family

donepezil

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

InChI

1S/C24H29NO3.ClH/c1-27-22-14-19-13-20(24(26)21(19)15-23(22)28-2)12-17-8-10-25(11-9-17)16-18-6-4-3-5-7-18;/h3-7,14-15,17,20H,8-13,16H2,1-2H3;1H

InChI key

XWAIAVWHZJNZQQ-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.
Donepezil Hydrochloride is known as a selective, reversible inhibitor of acetylcholinesterase enzyme. It exhibits therapeutic effect by raising the acetylcholine concentrations and improving the cholinergic function. It can be used in the treatment of mild to moderate dementia of the Alzheimer′s type.

Application

Donepezil Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by various chromatography techniques.
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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB3756 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Skull and crossbones

signalword

Danger

hcodes

Hazard Classifications

Acute Tox. 2 Oral - Eye Irrit. 2

Storage Class

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificados de análisis (COA)

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Quantitative determination of donepezil in human plasma by liquid chromatography/tandem mass spectrometry employing an automated liquid?liquid extraction based on 96-well format plates: Application to a bioequivalence study.
Apostolou C, et al.
Journal of Chromatography. B, Biomedical Sciences and Applications, 848(2), 239-244 (2007)
Stereoselective HPLC assay of donepezil enantiomers with UV detection and its application to pharmacokinetics in rats.
Radwan MA, et al.
Journal of Chromatography. B, Biomedical Sciences and Applications, 830(1), 114-119 (2006)
A new HPLC method to determine Donepezil hydrochloride in tablets.
Pappa H, et al.
Journal of Pharmaceutical and Biomedical Analysis, 27(1-2), 177-182 (2002)

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