Description

Ofloxacin Related Compound A (25 Mg) ((Rs)-9-Fluoro-2,3-Dihydro-3-Methyl-7-Oxo-10-(Pipera-Zin-1 -Yl)-7H-Pyrido[1,2,3-De]-1,4-Benzoxazine-6-Carboxylic Acid) is a high-purity analytical reference standard, essential for the quality control and regulatory compliance of the fluoroquinolone antibiotic ofloxacin. This compound serves as a critical impurity marker, enabling pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and purity of their final drug products. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of specific impurities in ofloxacin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to meet ICH Q3B (R2) guidelines for impurities in new drug substances.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor and control impurity levels, ensuring consistency and compliance with pharmacopeial standards (USP, EP, JP).
• Stability Studies: Acts as a reference point in forced degradation and long-term stability studies to track the formation of related substances over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of ofloxacin.

Basic Information

Product Name	Ofloxacin Related Compound A (25 Mg) ((Rs)-9-Fluoro-2,3-Dihydro-3-Methyl-7-Oxo-10-(Pipera-Zin-1 -Yl)-7H-Pyrido[1,2,3-De]-1,4-Benzoxazine-6-Carboxylic Acid)
CAS No.	82419-52-1
Molecular Formula	C18H20FN3O4
Molecular Weight	361.37 g/mol
Synonyms	(RS)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid; Ofloxacin Impurity A; Ofloxacin Related Substance A; 9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic Acid; DL-8280 Impurity A; (±)-Ofloxacin Impurity A; Ofloxacin EP Impurity A
EINECS	Contact for details

Quality Control

Our Ofloxacin Related Compound A is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each unit, documenting batch-specific results. Our quality commitment aligns with the standards expected for materials used in GMP environments and regulatory submissions.

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 with appropriate laboratory safety practices to prevent contamination.

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 ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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