Description

Alverine Citrate Impurity C is a specified impurity associated with the active pharmaceutical ingredient Alverine Citrate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Alverine Citrate drug substances and finished products. This high-purity material is primarily targeted at pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in API production and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Alverine Citrate API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopoeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of degradation products in stability testing of Alverine Citrate formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Alverine Citrate Impurity C
CAS No.	13125-63-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alverine Related Compound C; Alverine Citrate Related Substance C; N-Ethyl-3-phenyl-N-(3-phenylpropyl)propan-1-amine Citrate Impurity; 1-Propanamine, N-ethyl-N-(3-phenylpropyl)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1); Alverine EP Impurity C; Alverine Citrate Impurity Standard; Alverine Citrate Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Alverine Citrate Impurity C is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a comprehensive Certificate of Analysis (COA) that includes data from advanced techniques such as HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We support compliance with ICH guidelines and can provide materials suitable for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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