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PHR2025

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Desbenzyl donepezil hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

5,6-Dimethoxy-2-(piperidin-4-ylmethyl)indan-1-one hydrochloride

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About This Item

Fórmula empírica (notación de Hill):
C17H23NO3 · HCl
Número de CAS:
Peso molecular:
325.83
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to USP 1171819

API family

donepezil

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

InChI

1S/C17H23NO3.ClH/c1-20-15-9-12-8-13(7-11-3-5-18-6-4-11)17(19)14(12)10-16(15)21-2;/h9-11,13,18H,3-8H2,1-2H3;1H

InChI key

WOZXDQQCMZIQEG-UHFFFAOYSA-N

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General description

Desbenzyl donepezil hydrochloride is a metabolite of drug, donepezil hydrochloride. Donepezil hydrochloride is a neurocognition-enhancing drug prescribed especially to manage dementia during Alzheimer′s disease.
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

Donepezil hydrochloride can be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high performance liquid chromatography.
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 USP, EP and BP primary standards, where they are available.

Other Notes

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB4752 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

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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Visite la Librería de documentos

Donepezil for dementia due to Alzheimer's disease
Birks JS and Harvey RJ
Cochrane database of systematic reviews (Online) (2018)
RP-HPLC method for the estimation of donepezil hydrochloride dosage form
Barot TG and Patel PK
Journal of Chemistry, 6(2), 594-600 (2009)
Determination of donepezil hydrochloride in human plasma and pharmaceutical formulations by HPLC with fluorescence detection
Abonassif M, et al
Acta pharmaceutica, 61(4), 403-413 (2011)
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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