Description

n-Desethyl Brinzolamide-13C,D3 is a stable isotope-labeled analog of a key metabolite of the carbonic anhydrase inhibitor Brinzolamide. This compound is of critical importance for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolism studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in advanced drug development and regulatory compliance testing.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of Brinzolamide and its metabolites in biological matrices (plasma, urine, tissues) using mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of Brinzolamide.
• Bioanalytical Method Development and Validation: Serves as a critical reference material for developing robust, sensitive, and GLP-compliant analytical assays.
• Clinical Trial Support: Enables accurate measurement of drug and metabolite levels in patient samples during clinical phases.
• Impurity Profiling and Characterization: Aids in the identification and quantification of specific degradants or metabolites in drug substance and product analysis.
• Regulatory Submissions: Supports data packages submitted to agencies like the FDA and EMA by providing traceable and definitive analytical results.

Basic Information

Product Name	n-Desethyl Brinzolamide-13C,D3
CAS No.	1246816-82-9
Molecular Formula	C11H813C D3 N3 O5 S3
Molecular Weight	~ 387.36 g/mol
Synonyms	Brinzolamide Desethyl-13C,D3; 4-(Ethylamino-1,1,2,2,2-d5)-3',4'-dihydro-2'H,5'H-spiro[1-benzothiophene-4,4'-imidazolidine]-2',5'-dione 2,2-dioxide-13C; Brinzolamide N-Desethyl-13C,D3; Brinzolamide Metabolite Standard-13C,D3; AZOPT Metabolite-13C,D3; (R)-4-(Ethylamino-1,1,2,2,2-d5)-3',4'-dihydro-2'H,5'H-spiro[1-benzothiophene-4,4'-imidazolidine]-2',5'-dione 2,2-dioxide-13C; Stable Isotope Labeled n-Desethyl Brinzolamide
EINECS	Contact for details

Quality Control

Every batch of n-Desethyl Brinzolamide-13C,D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and MS. Certificates of Analysis (COA) are provided, detailing assay, isotopic enrichment, and impurity profiles to ensure compliance with the stringent requirements of analytical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99.0 atom % 13C; ≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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