Description

Benzhexol Impurity 6 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Benzhexol (Trihexyphenidyl) through precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality control. The product is supplied with comprehensive analytical data to support compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of specific impurities in Benzhexol (Trihexyphenidyl) API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to establish and validate chromatographic methods (HPLC, UPLC, GC) for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and regulatory compliance.
• Stability Studies: Utilized to track the formation of degradation products in Benzhexol formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research and Development: Supports synthetic chemistry research, metabolic studies, and the investigation of degradation pathways for Benzhexol and related compounds.

Basic Information

Product Name	Benzhexol Impurity 6 Hcl
CAS No.	344890-62-6
Molecular Formula	C20H31NO.HCl
Molecular Weight	337.93 g/mol (Free base)
Synonyms	Trihexyphenidyl Impurity 6 Hcl; 1-Cyclohexyl-1-phenyl-3-(1-piperidinyl)-1-propanol Hydrochloride; Benzhexol Related Compound 6; Benzhexol EP Impurity 6; Benzhexol USP Impurity 6; Trihexyphenidyl Related Compound 6; α-Cyclohexyl-α-phenyl-1-piperidinepropanol Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Benzhexol Impurity 6 Hcl is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing to ensure identity, purity, and strength, aligning with current pharmacopeial expectations (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (IR, HPLC), assay (HPLC), related substances (HPLC), residual solvents (GC), and specific tests. Our quality commitment supports your regulatory and compliance needs for pharmaceutical development and manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.