Description

Brinzolamide Impurity9 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Brinzolamide. This compound is critical for ensuring the purity, safety, and efficacy of ophthalmic drug formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Brinzolamide Impurity9 in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): Provides a benchmark for impurity profiling to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Brinzolamide formulations under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing characterized impurity data.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purification processes.

Basic Information

Product Name	Brinzolamide Impurity9
CAS No.	2183841-60-1
Molecular Formula	C12H21N3O5S3
Molecular Weight	399.51 g/mol
Synonyms	Brinzolamide Related Compound 9; Brinzolamide EP Impurity 9; Brinzolamide USP Impurity 9; 4-Ethylamino-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-dioxide; (R)-4-Ethylamino-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-dioxide; Brinzolamide Process Impurity; AZOPT Impurity 9
EINECS	Contact for details

Quality Control

Our Brinzolamide Impurity9 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances. The quality control protocols are designed to meet the stringent requirements of pharmaceutical reference standards, aligning with ICH and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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