Description

Hydrochlorothiazide Impurity 28 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 Hydrochlorothiazide, a widely prescribed diuretic. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining the stringent quality control required in modern pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Hydrochlorothiazide drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate product safety.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination.
• Research and Development (R&D): Facilitates chemical and pharmacological research into the degradation pathways and properties of Hydrochlorothiazide.

Basic Information

Product Name	Hydrochlorothiazide Impurity 28
CAS No.	40642-90-8
Molecular Formula	C₇H₈ClN₃O₄S₂
Molecular Weight	297.74 g/mol
Synonyms	6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; Hydrochlorothiazide Impurity K; Hydrochlorothiazide Related Compound K; HCTZ Impurity 28; 6-Chloro-1,1-dioxo-3,4-dihydro-2H-1λ⁶,2,4-benzothiadiazine-7-sulfonamide; 6-Chloro-7-sulfamoyl-1,2,4-benzothiadiazine 1,1-dioxide; HCTZ EP Impurity K
EINECS	Contact for details

Quality Control

Our Hydrochlorothiazide Impurity 28 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the results for identity, purity, and related substances. Our quality standards align with the requirements for pharmaceutical reference materials, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture absorption. For long-term storage, consider storing under inert conditions.

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 individual unknown impurity ≤ 0.5%
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.