Description

Brinzolamide Impurity CAS NO 171273-35-1 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Brinzolamide. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of ophthalmic drug formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Brinzolamide API and finished drug products.
• Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH guidelines.
• Stability Studies: Employed to identify and track degradation products in Brinzolamide formulations under various stress conditions.
• Quality Control (QC) Testing: A critical component in the routine QC release testing of Brinzolamide bulk drug and ophthalmic preparations like suspensions.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by agencies like the US FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Item	Details
Product Name	Brinzolamide Impurity
CAS No.	171273-35-1
Molecular Formula	C12H21N3O5S3
Molecular Weight	399.51 g/mol
Synonyms	Brinzolamide Related Compound; (4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide; Brinzolamide Degradant; Brinzolamide Process Impurity; AZOPT Impurity; Alcon BRZ Impurity; 4-(Ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide
EINECS	Contact for details

Quality Control

Every batch of Brinzolamide Impurity (CAS 171273-35-1) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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