Description

Biperiden Hydrochloride is a high-purity pharmaceutical active ingredient (API) and research chemical. This compound is a critical intermediate and reference standard in the development and quality control of anticholinergic medications. It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories for use in formulation development, clinical studies, and analytical method validation.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of anticholinergic medications for the treatment of Parkinson's disease and drug-induced extrapyramidal symptoms.
• Reference Standard: Serves as a certified reference material (CRM) for quality control, HPLC/LC-MS calibration, and assay validation in pharmaceutical analysis.
• Biochemical Research: Used in neurological and pharmacological studies to investigate muscarinic acetylcholine receptor (mAChR) antagonism and related pathways.
• Process Development: Employed as a key intermediate in the synthetic route development and scale-up of related pharmaceutical compounds.
• Impurity Standard: Utilized for the identification and quantification of related substances in compliance with ICH guidelines for drug substance specifications.

Basic Information

Product Name	Biperiden Hydrochloride
CAS No.	475563-22-5
Molecular Formula	C21H29NO • HCl
Molecular Weight	347.92 g/mol (as hydrochloride salt)
Synonyms	Biperiden HCl; 1-(Bicyclo[2.2.1]hept-5-en-2-yl)-1-phenyl-3-(piperidin-1-yl)propan-1-ol hydrochloride; Akineton Hydrochloride; α-Bicyclo[2.2.1]hept-5-ene-2-yl-α-phenyl-1-piperidinepropanol hydrochloride; 1-Piperidinepropanol, α-bicyclo[2.2.1]hept-5-en-2-yl-α-phenyl-, hydrochloride; Biperiden Hydrochloride (USP); Biperidene Hydrochloride
EINECS	Contact for details

Quality Control

Our Biperiden Hydrochloride is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and impurity profiles, aligning with pharmacopeial standards such as USP and ICH Q3A/B. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.