Description

Trihexyphenidyl Impurity 9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Trihexyphenidyl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in Trihexyphenidyl API and its drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions as per ICH stability testing protocols.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Trihexyphenidyl.

Basic Information

Item	Details
Product Name	Trihexyphenidyl Impurity 9
CAS No.	6853-22-1
Molecular Formula	C20H31NO
Molecular Weight	301.47 g/mol
Synonyms	1-Cyclohexyl-1-phenyl-3-(1-piperidinyl)-1-propanol; Benzhexol Impurity 9; Trihexyphenidyl Related Compound 9; 3-(1-Piperidinyl)-1-cyclohexyl-1-phenyl-1-propanol; α-Cyclohexyl-α-phenyl-1-piperidinepropanol; Artane Impurity 9; Pipanol Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Trihexyphenidyl Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and stability, aligning with current pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, and impurity profile is provided with each shipment.

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 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)	Individual unknown 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.