Description

Mequitazine Impurity CAS NO 151129-16-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the pharmaceutical substance Mequitazine by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and product development.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Mequitazine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Assurance: Employed in routine QC testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Mequitazine formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Synthesis: Acts as a starting material or intermediate for synthetic chemists researching related compounds or developing impurity synthesis pathways.

Basic Information

Product Name	Mequitazine Impurity
CAS No.	151129-16-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mequitazine Related Compound; Mequitazine Specified Impurity; 1-[(4-Methylphenyl)methyl]-4-[(3-methylphenyl)methyl]piperazine (tentative, based on structure); Mequitazine Process Impurity; Mequitazine Degradant; Mequitazine CRM; Mequitazine Reference Standard; CAS 151129-16-7
EINECS	Contact for details

Quality Control

Our Mequitazine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices to maintain stability and purity.

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 unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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