Description

Gemifloxacin Impurity CAS NO 213672-25-4 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 (API) Gemifloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for maintaining the highest standards in pharmaceutical production.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in Gemifloxacin mesylate API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to track the formation of degradation products in Gemifloxacin formulations under various stress conditions.
• Research & Development (R&D): Used in synthetic chemistry research to study the formation pathways and properties of this specific impurity.
• Pharmacopoeial Standards: Can be utilized as a working standard in conjunction with official pharmacopoeial monographs (e.g., USP, EP) for Gemifloxacin.

Basic Information

Product Name	Gemifloxacin Impurity
CAS No.	213672-25-4
Molecular Formula	C18H20FN5O4
Molecular Weight	389.38 g/mol
Synonyms	7-[(4Z)-3-(Aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid; Gemifloxacin Related Compound; Gemifloxacin Impurity A; (Z)-7-(3-(Aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid; Factive Impurity; LB20304a Impurity
EINECS	Contact for details

Quality Control

Every batch of Gemifloxacin Impurity (CAS 213672-25-4) is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, typically determined by advanced chromatographic techniques like HPLC and LC-MS. Our standards are suitable for use in cGMP environments, supporting regulatory compliance for pharmaceutical development and quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider conditions under an inert atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.