Description

Betahistine Impurity 2 Trihcl is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Betahistine, a medication used to treat vertigo and Meniere's disease. It is essential for analytical laboratories, quality assurance departments, and manufacturers involved in the synthesis and purification of active pharmaceutical ingredients (APIs). Ensuring the integrity of your final drug product requires reliable and well-characterized impurity standards like this one.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Betahistine API and finished dosage forms.
• Method Development & Validation: Critical for developing and validating analytical methods (e.g., HPLC, UPLC, GC) to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC testing of Betahistine batches to ensure they meet stringent pharmacopoeial specifications (e.g., USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Betahistine.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control.
• Research & Development: Supports synthetic chemistry research aimed at optimizing manufacturing processes to minimize this specific impurity.

Basic Information

Product Name	Betahistine Impurity 2 Trihcl
CAS No.	128225-22-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Betahistine Related Compound B; Betahistine Impurity B; 2-[2-(Methylamino)ethyl]pyridine trihydrochloride; Betahistine EP Impurity B; Betahistine USP Impurity; N-Methyl-2-pyridineethanamine trihydrochloride; Betahistine Process Impurity
EINECS	Contact for details

Quality Control

Our Betahistine Impurity 2 Trihcl is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, providing batch-specific data on identity, purity, and impurities. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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