Description

Dorzolamide Impurity 5 is a specified impurity of the active pharmaceutical ingredient Dorzolamide, a carbonic anhydrase inhibitor used in ophthalmic solutions. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories in the pharmaceutical industry to ensure the purity, safety, and efficacy of Dorzolamide-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Dorzolamide Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Dorzolamide manufacturing processes.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines) for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to establish product shelf-life.
• 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.
• Research & Development: Supports synthetic route optimization and process chemistry studies to minimize impurity formation during API synthesis.

Basic Information

Product Name	Dorzolamide Impurity 5
CAS No.	147128-79-8
Molecular Formula	C10H16N2O5S3
Molecular Weight	340.43 g/mol
Synonyms	(4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide; Dorzolamide Related Compound B; Dorzolamide EP Impurity B; Dorzolamide USP Impurity; L-671,152; 5,6-Dihydro-4-(ethylamino)-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide; (4S-trans)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide
EINECS	Contact for details

Quality Control

Every batch of Dorzolamide Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identification (IR, NMR), and residual solvent analysis.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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 Q3C guidelines

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