Description

Hydrochlorothiazide Impurity 22 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 pharmaceutical products containing hydrochlorothiazide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Hydrochlorothiazide Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation and understand the degradation pathways of Hydrochlorothiazide.
• Quality Control & Batch Release: Used as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency and purity of the API.
• Research & Development: Supports chemical research, including synthetic route optimization and the study of impurity formation mechanisms during the manufacturing process.

Basic Information

Item	Detail
Product Name	Hydrochlorothiazide Impurity 22
CAS No.	99418-26-5
Molecular Formula	C₇H₈ClN₃O₄S₂
Molecular Weight	297.74 g/mol
Synonyms	Hydrochlorothiazide Related Compound 22; 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; Hydrochlorothiazide EP Impurity H; Hydrochlorothiazide USP Related Compound A (context-dependent); HCTZ Impurity 22; 6-Chloro-7-sulfamoyl-3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide; 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-, 1,1-dioxide
EINECS	Contact for details

Quality Control

Every batch of Hydrochlorothiazide Impurity 22 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing results from HPLC purity, related substances, residual solvents, and other relevant tests is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity. 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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