Description

Alverine Citrate Impurity 5 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of Alverine Citrate, an antispasmodic pharmaceutical agent, by serving as a known benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality standards in drug substance and finished product manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Alverine Citrate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to accurately detect and measure specific impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure product specifications for impurity limits are met, as per ICH Q3A/B guidelines.
• Stability Studies: Used to monitor the formation of degradation products in Alverine Citrate formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Research & Development (R&D): Utilized in pharmaceutical R&D to study impurity formation pathways, synthesis by-products, and to establish purification processes.

Basic Information

Product Name	Alverine Citrate Impurity 5
CAS No.	93948-19-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alverine Related Compound; Alverine Citrate Related Substance; Alverine Impurity 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 Citrate EP Impurity; Alverine Citrate USP Impurity
EINECS	Contact for details

Quality Control

Our Alverine Citrate Impurity 5 is manufactured under strict quality systems to ensure it meets the exacting standards required for a reference material. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each lot, containing batch-specific data on purity, impurities, and analytical results. We support compliance with pharmacopeial standards (USP, EP) and ICH guidelines.

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. Ensure the container is sealed immediately after use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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