Description

Oxolinic Acid Impurity A is a specified impurity and reference standard used in the quality control of the antibacterial agent Oxolinic Acid. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Oxolinic Acid Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development and validation to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical QC labs to ensure Oxolinic Acid meets pharmacopeial purity specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to monitor impurity formation under various stress conditions.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and safety assessments.
• Research & Development: Used in synthetic chemistry R&D to study degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Oxolinic Acid Impurity A
CAS No.	26893-27-6
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; Oxolinic Acid Related Compound A; 6,7-Methylenedioxy-1-ethyl-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; Quinolone Impurity A
EINECS	Contact for details

Quality Control

Our Oxolinic Acid Impurity A is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, GC-MS, and NMR to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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