PHR1584

Donepezil Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• 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

Properties

• 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

Description

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.

Safety Information

• Pictograms: GHS06
• Signal Word: Danger
• Hazard Statements: H300,H319
• Precautionary Statements: P264 - P270 - P280 - P301 + P310 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Acute Tox. 2 Oral - Eye Irrit. 2
• Storage Class Code: 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable