Description

Dorzolamide Ep Impurity A Hcl is a high-purity reference standard and pharmaceutical impurity critical for analytical development and quality control. This compound is essential for ensuring the safety and efficacy of the active pharmaceutical ingredient Dorzolamide, a carbonic anhydrase inhibitor used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Dorzolamide API and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch testing to ensure Dorzolamide products meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key intermediate or marker in the synthesis and purification process development of Dorzolamide.

Basic Information

Product Name	Dorzolamide Ep Impurity A Hcl
CAS No.	122028-36-8
Molecular Formula	C10H17N3O5S3 • HCl
Molecular Weight	408.88 g/mol (Free base: 371.46 g/mol)
Synonyms	(4S,6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide Hydrochloride; Dorzolamide Related Compound A; Dorzolamide Impurity A HCl; Dorzolamide EP Impurity A; (4S-trans)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide Hydrochloride; L-671,152; Trusopt Impurity A
EINECS	Contact for details

Quality Control

Every batch of Dorzolamide Ep Impurity A Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards such as EP (European Pharmacopoeia) and USP (United States Pharmacopeia). A comprehensive Certificate of Analysis (COA) detailing all test results, including HPLC purity, is provided with each shipment to support your regulatory and quality needs.

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 inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.