Description

Brinzolamide Related Compound B is a high-purity chemical reference standard, essential for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Brinzolamide through precise impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and research and development activities.

Application

• Pharmaceutical Impurity Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Brinzolamide API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for Brinzolamide analysis.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to identify and track degradation products formed during the forced degradation and long-term stability testing of Brinzolamide formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control of the manufacturing process.
• Research & Development: Facilitates metabolic studies, pharmacokinetic research, and the synthesis of novel derivatives in pharmaceutical R&D.

Basic Information

Product Name	Brinzolamide Related Compound B
CAS No.	220402-83-5
Molecular Formula	C12H21N3O5S3
Molecular Weight	399.51 g/mol
Synonyms	4-(Ethylamino)-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-dioxide; Brinzolamide Impurity B; Brinzolamide EP Impurity B; Brinzolamide Related Substance B; (4S)-4-(Ethylamino)-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-dioxide; AZOPT Impurity B; Al 4862 Impurity B
EINECS	Contact for details

Quality Control

Our Brinzolamide Related Compound B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for a reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided 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. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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