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PHR1584

Supelco

Donepezil Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
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
Empirical Formula (Hill Notation):
C24H29NO3 · HCl
CAS Number:
120011-70-3
Molecular Weight:
415.95
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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.

related product

Product No.
Description
Pricing

1224992

Donepezil related compound A, United States Pharmacopeia (USP) Reference Standard

1224981

Donepezil hydrochloride, United States Pharmacopeia (USP) Reference Standard

1171819

Desbenzyl donepezil hydrochloride, United States Pharmacopeia (USP) Reference Standard

1224970

Donepezil-N-oxide, United States Pharmacopeia (USP) Reference Standard

PHR2023

(E)-2-[(1-Benzylpiperidin-4-yl)methylene]-5,6-dimethoxyindan-1-one(Donepezil Related Compound A), Pharmaceutical Secondary Standard; Certified Reference Material

PHR2024

Donepezil-N-Oxide, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2025

Desbenzyl donepezil hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

Y0002165

Donepezil for system suitability, CRS, European Pharmacopoeia (EP) Reference Standard

Y0002160

Donepezil hydrochloride, CRS, European Pharmacopoeia (EP) Reference Standard

Pictograms

Skull and crossbones
GHS06

Signal Word

Danger

Hazard Statements

H300,H319

Hazard Classifications

Acute Tox. 2 Oral - Eye Irrit. 2

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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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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