Description

Terfenadine Related Compound B is a high-purity chemical reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. Its primary value lies in its use as a critical marker for the identification, quantification, and monitoring of related substances in Terfenadine and its derivative products. This compound is essential for research laboratories, analytical service providers, and pharmaceutical manufacturers engaged in method validation, stability studies, and ensuring regulatory compliance for antihistamine drug substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in pharmacopeial testing (USP, EP).
• Process Impurity Profiling: Used to monitor and control the formation of specific related substances during the synthesis of Terfenadine.
• Method Development & Validation: A critical component in developing and validating analytical methods for purity and stability-indicating assays.
• Stability Studies: Employed to identify and quantify degradation products in Terfenadine drug substance and finished product stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding and control of product-related impurities.
• Chemical Synthesis: Acts as a key intermediate or starting material for the research-scale synthesis of Terfenadine analogs and metabolites.
• Quality Control Laboratories: Used for system suitability testing and as a qualitative/quantitative control in routine QC release testing.

Basic Information

Item	Detail
Product Name	Terfenadine Related Compound B
CAS No.	634901-83-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terfenadine Impurity B; Terfenadine Related Substance B; α-[4-(1,1-Dimethylethyl)phenyl]-4-(hydroxydiphenylmethyl)-1-piperidinebutanol (specify isomer); Terfenadine Process Impurity; Terfenadine Degradant; (RS)-[4-(4-Hydroxy-α,α-diphenylbenzyl)piperidino]butyl]-α-(tert-butyl)benzenemethanol; Terfenadine Analog
EINECS	Contact for details

Quality Control

Our Terfenadine Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality commitment aligns with the expectations of cGMP and ISO 9001 standards for research and diagnostic chemicals.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.