Description

Benzhexol Impurity 11 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in the active pharmaceutical ingredient (API) Trihexyphenidyl Hydrochloride (Benzhexol Hydrochloride). It is primarily used by analytical chemists and quality control professionals in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance during method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development and validation in API manufacturing.
• Quality Control & Assurance: Used for the identification and quantification of Benzhexol Impurity 11 in Trihexyphenidyl Hydrochloride drug substance and finished dosage forms.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) for Trihexyphenidyl Hydrochloride.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize impurity formation.

Basic Information

Product Name	Benzhexol Impurity 11
CAS No.	90548-89-3
Molecular Formula	C20H31NO
Molecular Weight	301.47 g/mol
Synonyms	Trihexyphenidyl Impurity 11; 1-Cyclohexyl-1-phenyl-3-(1-piperidinyl)-1-propanol; α-Cyclohexyl-α-phenyl-1-piperidinepropanol; Benzhexol Related Compound 11; Trihexyphenidyl Related Substance 11; Artane Impurity 11; 1-Piperidinepropanol, α-cyclohexyl-α-phenyl-
EINECS	Contact for details

Quality Control

Every batch of Benzhexol Impurity 11 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC, and NMR, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against stringent in-house specifications. We support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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