Description

Meclizine Impurity 2 CAS NO 5321-65-3 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Meclizine, an antihistamine used to treat nausea, vomiting, and dizziness. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining strict compliance with global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Meclizine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control strategies.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions.
• Research & Development: Facilitates studies on the degradation pathways, pharmacokinetics, and toxicological profile of Meclizine.

Basic Information

Product Name	Meclizine Impurity 2
CAS No.	5321-65-3
Molecular Formula	C25H27ClN2
Molecular Weight	390.95 g/mol
Synonyms	1-[(4-Chlorophenyl)(phenyl)methyl]-4-[(3-methylphenyl)methyl]piperazine; Meclizine Related Compound B; Meclizine EP Impurity B; Meclizine USP Impurity; 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl)piperazine; CAS 5321-65-3; Meclizine Impurity
EINECS	Contact for details

Quality Control

Every batch of Meclizine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques. We support compliance with ICH, USP, and EP guidelines, and material can be supplied to meet specific customer specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to prevent potential degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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