Description

Trihexyphenidyl Impurity 5 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Trihexyphenidyl. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a known benchmark for impurity identification and quantification. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Trihexyphenidyl HCl API and related drug products.
• Analytical Method Development & Validation (HPLC/GC): Used to establish and validate chromatographic methods for impurity profiling and stability studies.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability testing of pharmaceutical formulations.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Trihexyphenidyl.

Basic Information

Product Name	Trihexyphenidyl Impurity 5
CAS No.	4352-39-0
Molecular Formula	C20H31NO
Molecular Weight	301.47 g/mol
Synonyms	1-Cyclohexyl-1-phenyl-3-(1-piperidinyl)-1-propanol; Benzhexol Impurity 5; Trihexyphenidyl Related Compound 5; 3-Piperidino-1-cyclohexyl-1-phenyl-1-propanol; α-Cyclohexyl-α-phenyl-1-piperidinepropanol; Trihexyphenidyl EP Impurity B; Trihexyphenidyl USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Trihexyphenidyl Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming suitability for use as a reference material.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential 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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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