Description

Mequitazine Impurity CAS NO 151129-13-4 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in the active pharmaceutical ingredient (API) Mequitazine, ensuring drug safety and efficacy. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing of Mequitazine API to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry R&D: Aids in the optimization of synthesis and purification processes by identifying and quantifying process-related impurities.
• Pharmacopoeial Standards: Can be utilized in the development and verification of monograph tests for pharmacopoeias such as USP, EP, or BP.

Basic Information

Product Name	Mequitazine Impurity
CAS No.	151129-13-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	10-[(1-Methyl-3-piperidinyl)methyl]-10H-phenothiazine; Mequitazine Related Compound; Mequitazine Related Substance; Phenothiazine, 10-[(1-methyl-3-piperidinyl)methyl]-; Mequitazine Impurity Standard; Mequitazine CRM; Mequitazine Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Mequitazine Impurity CAS NO 151129-13-4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopoeial standards. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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