Description

Metolazone Impurity A CAS NO 28524-40-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Metolazone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Metolazone API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation of Impurity A in Metolazone drug products under various stress conditions to determine shelf life.
• Regulatory Compliance & Filings: A necessary component for compiling regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Metolazone.
• Pharmacopoeial Testing: Applied as a system suitability standard in testing procedures aligned with USP, EP, or other pharmacopoeial monographs for Metolazone.

Basic Information

Product Name	Metolazone Impurity A
CAS No.	28524-40-5
Molecular Formula	C16H16ClN3O3S
Molecular Weight	365.84 g/mol
Synonyms	7-Chloro-1,2,3,4-tetrahydro-2-methyl-4-oxo-3-o-tolyl-6-quinazolinesulfonamide; 7-Chloro-2-methyl-4-oxo-3-(2-methylphenyl)-1,2,3,4-tetrahydro-6-quinazolinesulfonamide; Metolazone Related Compound A; Metolazone EP Impurity A; Metolazone USP Impurity A; Metolazone Degradation Product; Zaroxolyn Impurity A
EINECS	Contact for details

Quality Control

Every batch of Metolazone Impurity A is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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