Description

Oxolinic Acid Impurity B is a specified impurity and analytical reference standard used in the quality control of the antibiotic Oxolinic Acid. This high-purity compound is critical for pharmaceutical research, development, and manufacturing, enabling precise identification and quantification of related substances. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Oxolinic Acid Impurity B in active pharmaceutical ingredient (API) batches.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities in Oxolinic Acid synthesis.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Oxolinic Acid meets pharmacopeial standards (e.g., USP, EP) for impurity profiles.
• Stability Studies: Employed in forced degradation and shelf-life studies to understand the degradation pathways and stability of Oxolinic Acid formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and impurity levels.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and track by-products.

Basic Information

Product Name	Oxolinic Acid Impurity B
CAS No.	16172-03-5
Molecular Formula	C13H11NO5
Molecular Weight	261.23 g/mol
Synonyms	1-Ethyl-1,4-dihydro-6,7-methylenedioxy-4-oxoquinoline-3-carboxylic Acid; 1-Ethyl-6,7-methylenedioxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; 6,7-Methylenedioxy-1-ethyl-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; Oxolinic Acid Related Compound B; Decarboxy Oxolinic Acid; Oxolinic Acid Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Oxolinic Acid Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled and stored away from direct light exposure to maintain stability.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5% w/w

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