Description

Sulindac Related Compound A (20 Mg) (trans-Sulindac) CAS NO 53933-60-1 is a high-purity reference standard material, specifically the trans-isomer of the nonsteroidal anti-inflammatory drug (NSAID) Sulindac. This compound is critical for ensuring analytical accuracy, method validation, and regulatory compliance in pharmaceutical research and quality control laboratories. It is primarily used by scientists and quality assurance professionals in pharmaceutical development, contract research organizations (CROs), and regulatory testing facilities.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, purity assessment, and quantification of Sulindac and its related substances in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and other chromatographic methods to separate and analyze Sulindac isomers and impurities.
• Quality Control (QC) Testing: Serves as a system suitability standard and a known impurity marker in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies & Degradation Profiling: Employed in forced degradation studies to understand the stability profile of Sulindac and to identify and characterize potential degradation products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling and control strategies for drug substances and products.
• Research & Development: Used in biochemical and pharmacological research to study the metabolism, activity, and properties of Sulindac and its isomers.

Basic Information

Product Name	Sulindac Related Compound A (20 Mg) (trans-Sulindac)
CAS No.	53933-60-1
Molecular Formula	C20H17FO3S
Molecular Weight	356.41 g/mol
Synonyms	(Z)-5-Fluoro-2-methyl-1-[[4-(methylsulfinyl)phenyl]methylene]-1H-indene-3-acetic acid; trans-Sulindac; (Z)-Sulindac; Sulindac Impurity A; Sulindac Related Substance A; Sulindac isomer; FGN-1
EINECS	Contact for details

Quality Control

Our Sulindac Related Compound A is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay results, and test methods (e.g., HPLC, NMR) is provided with every unit to support your regulatory and research needs.

Storage

Preserve in the original, tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practice.

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)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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