Description

Flavoxate Related Compound C (20 Mg) (3-Methylflavone-8-Carboxylic Acid Ethyl Ester) is a high-purity analytical reference standard used for pharmaceutical quality control and research. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Flavoxate, a urinary antispasmodic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling in compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Reference Standard: Used as a specified impurity (Related Compound C) in the quality control and release testing of Flavoxate HCl API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component for developing and validating HPLC, UPLC, or GC methods to quantify impurities in Flavoxate batches.
• Stability Studies: Employed as a marker compound to monitor degradation pathways and establish shelf-life for Flavoxate-containing pharmaceutical products.
• Regulatory Compliance & Documentation: Essential for generating regulatory submission documents (e.g., for FDA, EMA) that require full impurity characterization and identification.
• Pharmacopeial Testing: Used to comply with testing requirements outlined in pharmacopeias such as USP, EP, or JP for Flavoxate monographs.
• Research & Development: Utilized in synthetic chemistry R&D for studying Flavoxate metabolism, synthesis pathways, and derivative development.

Basic Information

Product Name	Flavoxate Related Compound C (20 Mg) (3-Methylflavone-8-Carboxylic Acid Ethyl Ester)
CAS No.	35888-94-9
Molecular Formula	C19H16O4
Molecular Weight	308.33 g/mol
Synonyms	3-Methylflavone-8-carboxylic Acid Ethyl Ester; Ethyl 3-Methyl-8-oxo-8H-chromene-2-carboxylate; Flavoxate Impurity C; Flavoxate Related Substance C; Flavoxate EP Impurity C; 2-Ethoxycarbonyl-3-methylchromone; 8-Carbethoxy-3-methylchromone; 3-Methyl-8-oxo-8H-1-benzopyran-2-carboxylic Acid Ethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Flavoxate Related Compound C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for purity, related substances, and identification. Our quality commitment aligns with cGMP principles and supports compliance with USP, EP, and ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccation.

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 ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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