Description

Dorzolamide n-Acetyl Impurity is a key process-related impurity and a degradation product of the active pharmaceutical ingredient Dorzolamide. This compound is critical for pharmaceutical research, development, and quality control, serving as a certified reference standard for analytical method validation and impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Dorzolamide-based ophthalmic solutions.

Application

• Primary use as a certified reference standard (CRS) for the quantitative and qualitative analysis of Dorzolamide.
• Critical for impurity profiling and identification during the drug development and manufacturing process.
• Essential component in method validation and stability studies for Dorzolamide hydrochloride drug substances and finished dosage forms.
• Used in pharmacopoeial testing to comply with regulatory standards (e.g., USP, EP, ICH guidelines).
• Supports quality assurance/quality control (QA/QC) laboratories in monitoring and controlling impurity levels.
• Valuable for academic and industrial research into the degradation pathways and stability of carbonic anhydrase inhibitors.

Basic Information

Product Name	Dorzolamide n-Acetyl Impurity
CAS No.	403848-09-9
Molecular Formula	C19H26N4O5S2
Molecular Weight	454.57 g/mol
Synonyms	N-Acetyl Dorzolamide; (4S,6S)-4-(Ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-Dioxide N-Acetyl Impurity; Dorzolamide Related Compound A; Dorzolamide EP Impurity A; Dorzolamide Acetyl Impurity; L-671,152 n-Acetyl Impurity; 5,6-Dihydro-4-(ethylamino)-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide N-Acetyl Derivative
EINECS	Contact for details

Quality Control

Our Dorzolamide n-Acetyl Impurity is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity levels as determined by advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS). We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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