Description

Brinzolamide Impurity C is a specified impurity and a critical reference standard used in the analytical profiling of the active pharmaceutical ingredient Brinzolamide. This compound is essential for ensuring the purity, safety, and efficacy of the final ophthalmic drug product through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of carbonic anhydrase inhibitor medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Brinzolamide Impurity C in drug substance and finished product analysis.
• Method Development and Validation: Used in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Brinzolamide.
• Quality Control & Assurance: Critical for routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and improve the synthesis process of Brinzolamide.

Basic Information

Product Name	Brinzolamide Impurity C
CAS No.	186377-56-0
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; 4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide (stereochemistry unspecified); Brinzolamide Related Compound C; Brinzolamide EP Impurity C; Brinzolamide USP Impurity C; Brinzolamide Degradation Product; AZOPT Impurity C
EINECS	Contact for details

Quality Control

Every batch of Brinzolamide Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and traceability information.

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 must be kept under dry, inert conditions to maintain stability and purity. 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)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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