Description

Brinzolamide Impurity CAS NO 174139-67-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Brinzolamide, a carbonic anhydrase inhibitor used in ophthalmic solutions. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. The availability of this well-characterized impurity supports robust quality control processes in drug development and production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Brinzolamide API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Brinzolamide formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity identification and characterization reports.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purification processes.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Brinzolamide Impurity
CAS No.	174139-67-4
Molecular Formula	C12H21N3O5S3
Molecular Weight	399.51 g/mol
Synonyms	(4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide; Brinzolamide Related Compound; Brinzolamide EP Impurity; Brinzolamide USP Impurity; 4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide; AZOPT Impurity; Alcon Code A-75717 Impurity
EINECS	Contact for details

Quality Control

Our Brinzolamide Impurity is manufactured and handled in a GMP-compliant environment. Each batch undergoes rigorous analytical testing, including HPLC for purity and spectroscopic identification (IR, NMR, MS), to ensure it meets stringent specifications for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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)	Individual unknown 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.