Description

Levofloxacin Impurity 22 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Levofloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable supply of this well-characterized impurity is essential for maintaining stringent quality control in antibiotic production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Levofloxacin API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish system suitability, specificity, and detection limits.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity in drug substances and products to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Levofloxacin under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the behavior of Levofloxacin-related substances.

Basic Information

Product Name	Levofloxacin Impurity 22
CAS No.	177472-29-6
Molecular Formula	C18H20FN3O4
Molecular Weight	361.37 g/mol
Synonyms	Levofloxacin Related Compound 22; (S)-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 Impurity; 1-Cyclopropyl-7-(S)-fluoro-6,8-dihydro-8-methyl-1-oxo-1H,5H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic Acid Impurity (related); OFX Impurity; Levofloxacin EP Impurity G; Levofloxacin USP Related Substance; Levofloxacin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin Impurity 22 is manufactured and analyzed under strict quality systems. The product undergoes rigorous identity, purity, and assay testing via advanced analytical techniques including HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Assay (HPLC)	90.0% - 110.0% on dried basis
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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