Description

Enrofloxacin Impurity 1 CAS NO 1128234-60-5 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the veterinary fluoroquinolone antibiotic, Enrofloxacin. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Enrofloxacin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Pharmacopeial Testing: Used to demonstrate compliance with impurity limits specified in pharmacopeias such as USP, EP, BP, or ChP.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Enrofloxacin under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity profiles.
• Research & Development: Serves as a key intermediate or degradation product for synthetic pathway studies and impurity fate and tolerance investigations.

Basic Information

Product Name	Enrofloxacin Impurity 1
CAS No.	1128234-60-5
Molecular Formula	C19H22FN3O3
Molecular Weight	359.40 g/mol
Synonyms	1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Enrofloxacin Ethylpiperazine Impurity; Enrofloxacin Related Compound A; Enrofloxacin EP Impurity A; BAQ-1; 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid ethylpiperazine analog; Enrofloxacin N-Ethylpiperazine Impurity
EINECS	Contact for details

Quality Control

Every batch of Enrofloxacin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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