Description

Metolazone Impurity D 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 (API) Metolazone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support rigorous quality control protocols.

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 & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity identification and quantification.
• Stability Studies: Employed to monitor and quantify the formation of this specific impurity during forced degradation and long-term stability studies of Metolazone.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing a characterized impurity for identification and specification setting.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and metabolism of Metolazone.
• Quality Assurance/Control (QA/QC): Serves as a system suitability and identification marker in routine QC testing to ensure batch-to-batch consistency.

Basic Information

Product Name	Metolazone Impurity D
CAS No.	28508-63-6
Molecular Formula	C16H16ClN3O3S
Molecular Weight	365.84 g/mol
Synonyms	7-Chloro-1,2,3,4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide; 7-Chloro-2-methyl-3-(o-tolyl)-1,2,3,4-tetrahydro-4-oxoquinazoline-6-sulfonamide; Metolazone Related Compound D; Metolazone EP Impurity D; Metolazone USP Impurity D; 3-(2-Methylphenyl)-7-chloro-2-methyl-1,2,3,4-tetrahydro-4-oxoquinazoline-6-sulfonamide
EINECS	Contact for details

Quality Control

Every batch of Metolazone Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccants or inert atmosphere.

Specification

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

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