Description

Alverine Citrate Impurity 3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Alverine Citrate by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Alverine Citrate API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency and compliance.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control strategy.
• Research and Development: Facilitates studies on the synthesis pathway, degradation routes, and toxicological assessment of Alverine Citrate and its related compounds.

Basic Information

Product Name	Alverine Citrate Impurity 3
CAS No.	142047-93-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Ethyl-3-phenyl-N-(3-phenylpropyl)propan-1-amine citrate; Alverine related compound; Alverine Citrate Related Substance 3; Alverine impurity C; 1,3-Diphenylpropyl-diethyl-ammonium citrate; N,N-Diethyl-3,3-diphenylpropylamine citrate; Spacmon Impurity
EINECS	Contact for details

Quality Control

Our Alverine Citrate Impurity 3 is manufactured and handled in a GMP-compliant environment to ensure the highest standards of identity, purity, and stability. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to meet stringent pharmacopeial and ICH Q3 guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and all specified impurities.

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 reference spectrum
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)	≤ 1.0%

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