Description

Fampridine Impurity 3 CAS NO 1864897-67-5 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fampridine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research scientists in the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of impurities in Fampridine (4-aminopyridine) API batches.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Fampridine drug products to track impurity formation over time.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the Fampridine manufacturing process.

Basic Information

Product Name	Fampridine Impurity 3
CAS No.	1864897-67-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-Aminopyridine Impurity 3; 4-AP Impurity 3; Fampridine Related Compound 3; Ampyra Impurity 3; 4-Pyridinamine Impurity 3; 1864897-67-5; Process Impurity of Fampridine
EINECS	Contact for details

Quality Control

Every batch of Fampridine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques, and a detailed Certificate of Analysis (COA) providing purity, identity, and impurity profile data is available for each lot upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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