Description

Betahistine Impurity 3 is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker in the quality control and regulatory analysis of Betahistine, an active pharmaceutical ingredient used to treat vertigo and Meniere's disease. It is essential for analytical laboratories and pharmaceutical manufacturers engaged in method development, stability studies, and ensuring compliance with stringent pharmacopeial standards. The availability of this well-characterized impurity supports the production of safer and more effective pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Betahistine API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Employed to identify and track degradation products in stability-indicating methods for Betahistine.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure API and drug product purity meets ICH, USP, and EP guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process.

Basic Information

Product Name	Betahistine Impurity 3
CAS No.	13585-92-7
Molecular Formula	C8H12N2
Molecular Weight	136.20 g/mol
Synonyms	2-[2-(Methylamino)ethyl]pyridine; N-Methyl-2-(2-pyridyl)ethylamine; Pyridine, 2-[2-(methylamino)ethyl]-; Betahistine Related Compound C; Betahistine EP Impurity C; Betahistine USP Impurity; Betahistine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Betahistine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials qualified against USP and EP reference standards.

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 optimal stability.

Specification

Item	Specification
Appearance	Colorless to pale yellow liquid / oil
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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