Description

Alverine Citrate Impurity E is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in Alverine Citrate drug substance and finished pharmaceutical products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory compliance teams to ensure product safety, efficacy, and adherence to stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Impurity E in Alverine Citrate active pharmaceutical ingredient (API) and formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to establish system suitability and ensure batch-to-batch consistency of Alverine Citrate.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH requirements.
• Stability Studies: Used to monitor the formation of degradation products in Alverine Citrate under various stress conditions.
• Research and Development: Supports synthetic chemistry research for impurity synthesis, characterization, and route scouting for impurity control.

Basic Information

Product Name	Alverine Citrate Impurity E
CAS No.	878784-75-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Ethyl-N-(3-phenylpropyl)propan-1-amine Citrate Impurity E; Alverine Related Compound E; 1-(Dipropylamino)-3-phenylpropane Citrate Impurity; Alverine Citrate EP Impurity E; Alverine Citrate USP Impurity E; Spacolin Impurity E; Proverine Impurity E
EINECS	Contact for details

Quality Control

Every batch of Alverine Citrate Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with ICH Q3A, Q3B, USP, and EP guidelines. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced chromatographic and spectroscopic techniques. We are committed to supplying reference standards that meet the exacting requirements of global pharmaceutical quality assurance.

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. Handle and store under an inert atmosphere if prolonged storage is required.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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