Description

Mequitazine Impurity CAS NO 144827-81-6 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the manufacture of the antihistamine drug Mequitazine. It is primarily required by analytical laboratories and pharmaceutical companies engaged in method validation, stability studies, and ensuring compliance with stringent regulatory guidelines for drug substance purity.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Critical for identifying and characterizing unknown peaks in HPLC, UPLC, or GC chromatograms of Mequitazine active pharmaceutical ingredient (API).
• Method Development & Validation: Serves as a key component in developing and validating stability-indicating assay methods for quality control laboratories.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release: Used as a system suitability standard to ensure the accuracy and precision of routine QC testing of Mequitazine batches.

Basic Information

Product Name	Mequitazine Impurity
CAS No.	144827-81-6
Molecular Formula	C20H22N2S
Molecular Weight	322.47 g/mol
Synonyms	10-[(1-Methyl-3-piperidinyl)methyl]-10H-phenothiazine; Mequitazine Related Compound; Mequitazine Process Impurity; 10H-Phenothiazine, 10-[(1-methyl-3-piperidinyl)methyl]-; UNII-8V8T8Q178M; 8V8T8Q178M; Mequitazine Analog; Phenothiazine derivative (Mequitazine-related)
EINECS	Contact for details

Quality Control

Every batch of Mequitazine Impurity (CAS 144827-81-6) is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified standards and supporting cGMP requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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