Description

Brinzolamide Impurity CAS NO 165117-54-4 is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Brinzolamide. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of ophthalmic drug products by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on developing and validating robust analytical methods for carbonic anhydrase inhibitors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of related substances in Brinzolamide API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): A critical component for developing, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Brinzolamide products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Brinzolamide-containing drug products under various storage conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis, purification, and scale-up of Brinzolamide manufacturing processes.

Basic Information

Product Name	Brinzolamide Impurity
CAS No.	165117-54-4
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; AZOPT Impurity; Alcon Code A-75724; 4-(Ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide
EINECS	Contact for details

Quality Control

Our Brinzolamide Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

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 at 2-8°C. Handle and store in accordance with good laboratory practices.

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 guidelines
Water Content (KF)	≤ 1.0%

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