Description

Dorzolamide Impurity 32 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dorzolamide. This compound is critical for ensuring the purity, safety, and efficacy of ophthalmic drug formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Dorzolamide HCl API and finished drug products.
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in pharmaceutical R&D.
• Quality Control & Batch Release: Used in QC laboratories to monitor and control the level of this specific impurity during API synthesis and manufacturing.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and dossiers.
• Stability Studies: Employed to identify and track the formation of this impurity in Dorzolamide formulations under various stress and long-term storage conditions.
• Pharmacopoeial Testing: Used to ensure compliance with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits for Dorzolamide.

Basic Information

Product Name	Dorzolamide Impurity 32
CAS No.	897657-78-2
Molecular Formula	C10H16N2O5S3
Molecular Weight	340.44 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; Dorzolamide EP Impurity; Dorzolamide USP Impurity; Trusopt Impurity; L-671,152 Impurity; (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 32 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications developed for use as a pharmaceutical impurity reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The 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 solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.