Description

Flavoxate Related Compound B (20 Mg) (3-Methylflavone-8-Carboxylic Acid Methyl Ester) is a high-purity reference standard and pharmaceutical intermediate essential for 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 research institutions for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Flavoxate API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Pharmacological Research: Serves as a key intermediate or metabolite in studies investigating the pharmacokinetics and mechanism of action of Flavoxate.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity profiles and stability data.
• Chemical Synthesis: Acts as a building block or precursor in the synthesis of Flavoxate and related flavone derivatives for research purposes.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor and control the levels of specified and unspecified impurities.

Basic Information

Product Name	Flavoxate Related Compound B (20 Mg) (3-Methylflavone-8-Carboxylic Acid Methyl Ester)
CAS No.	90101-87-4
Molecular Formula	C19H16O4
Molecular Weight	308.33 g/mol
Synonyms	3-Methylflavone-8-carboxylic Acid Methyl Ester; 8-(Methoxycarbonyl)-3-methylflavone; Flavoxate Impurity B; Flavoxate Related Substance B; 2H-1-Benzopyran-2-one, 8-(methoxycarbonyl)-3-methyl-; 3-Methyl-8-carbomethoxyflavone; Flavoxate EP Impurity B
EINECS	Contact for details

Quality Control

Our Flavoxate Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results. We support compliance with ICH Q3B (R2) guidelines and other relevant pharmacopoeial standards.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (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%
Assay (on dried basis)	98.0% - 102.0%

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