Description

Trihexyphenidyl Impurity 9(Hcl) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and analytical profiling of Trihexyphenidyl Hydrochloride, an anticholinergic medication. It is essential for laboratories in the pharmaceutical and fine chemical sectors requiring precise impurity identification and quantification to ensure drug safety and regulatory compliance. The availability of this well-characterized impurity standard is fundamental for method validation and maintaining stringent quality assurance protocols.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of Trihexyphenidyl Impurity 9 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Critical for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Used to monitor impurity profiles and degradation pathways of Trihexyphenidyl HCl under various stress conditions.
• Regulatory Compliance and Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA, ICH) by providing necessary impurity data.
• Pharmacopoeial Testing: Aids in compliance testing against pharmacopoeial monographs (USP, EP, BP) that specify impurity limits.
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways and optimize purification processes to minimize this impurity.

Basic Information

Product Name	Trihexyphenidyl Impurity 9(Hcl)
CAS No.	65694-13-5
Molecular Formula	C20H31NO • HCl
Molecular Weight	337.93 g/mol (Free base: 301.47 g/mol)
Synonyms	1-Cyclohexyl-1-phenyl-3-pyrrolidin-1-ylpropan-1-ol Hydrochloride; Benzhexol Impurity 9; Trihexyphenidyl Related Compound 9; Trihexyphenidyl HCl Impurity 9; 3-(1-Pyrrolidinyl)-1-cyclohexyl-1-phenyl-1-propanol Hydrochloride; Artane Impurity 9; Pipanol Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Trihexyphenidyl Impurity 9(Hcl) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, GC) and spectroscopic (IR, NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting ICH Q3A/B guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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