Description

Benzhexol Impurity 9 CAS NO 136779-82-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Benzhexol (Trihexyphenidyl). It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Benzhexol (Trihexyphenidyl) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods like HPLC and UPLC to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against strict pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Utilized in academic and industrial R&D settings to study the degradation pathways and chemical behavior of Benzhexol.

Basic Information

Product Name	Benzhexol Impurity 9
CAS No.	136779-82-3
Molecular Formula	C20H31NO
Molecular Weight	301.47 g/mol
Synonyms	Trihexyphenidyl Impurity 9; 1-Cyclohexyl-1-phenyl-3-(1-piperidinyl)-1-propanol; α-Cyclohexyl-α-phenyl-1-piperidinepropanol; Benzhexol Related Compound 9; Benzhexol EP Impurity C; Trihexyphenidyl Related Compound A; α-Phenyl-α-cyclohexyl-1-piperidinepropanol
EINECS	Contact for details

Quality Control

Every batch of Benzhexol Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, purity, and specific impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material should be handled under inert conditions to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.