Description

Brinzolamide Impurity CAS NO 880162-03-8 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Brinzolamide, a carbonic anhydrase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Brinzolamide API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purification processes.

Basic Information

Product Name	Brinzolamide Impurity
CAS No.	880162-03-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brinzolamide Related Compound; Brinzolamide Process Impurity; Brinzolamide Degradant; (4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide; AZOPT Impurity; Alcon Product No. A-000009-05 Impurity
EINECS	Contact for details

Quality Control

Every batch of Brinzolamide Impurity (CAS 880162-03-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.