Description

Terfenadine Related Compound A (1-[4-(1,1-Dimethylethyl)Phenyl]-4-[4-(Hydroxydiphenylmethyl)-1-Piperidinyl]-1-Butanone) is a high-purity reference standard critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and their manufacturing processes. It is primarily used by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical industry for method development, validation, and impurity profiling. The CAS number for this compound is 76815-60-6.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Terfenadine and its formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and Mass Spectrometry (MS) methods.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing to monitor impurity levels and ensure drug substance and product specifications are met according to ICH, USP, or EP guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of the active pharmaceutical ingredient (API).
• Regulatory Compliance & Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate control over the manufacturing process and product purity.
• Research & Development: Used in synthetic chemistry research and metabolic studies to understand the chemical behavior and properties of Terfenadine analogs.

Basic Information

Product Name	Terfenadine Related Compound A (100 Mg)
CAS No.	76815-60-6
Molecular Formula	C32H39NO2
Molecular Weight	469.66 g/mol
Synonyms	1-[4-(1,1-Dimethylethyl)Phenyl]-4-[4-(Hydroxydiphenylmethyl)-1-Piperidinyl]-1-Butanone; Terfenadine Impurity A; Terfenadine Related Substance A; 4'-(1-Hydroxy-1,1-diphenylmethyl)-1-[4-(tert-butyl)phenyl]-4-piperidinyl-1-butanone; α-(4-(1,1-Dimethylethyl)phenyl)-4-(hydroxydiphenylmethyl)-1-piperidinebutyrophenone; Terfenadine EP Impurity A; Terfenadine USP Related Compound A
EINECS	Contact for details

Quality Control

Our Terfenadine Related Compound A is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, and impurity profiles as determined by validated methods such as HPLC and NMR. We support compliance with ICH Q3A, Q3B, USP, and European Pharmacopoeia (EP) guidelines for impurities.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to humidity or light should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% 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.