Description

Ciprofloxacin Related Compound CAS NO 528851-30-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is an essential material for analytical chemists, quality control laboratories, and R&D departments within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Ciprofloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Research & Development: Utilized in stability studies, degradation pathway elucidation, and synthetic chemistry research related to fluoroquinolone antibiotics.
• Calibration Standard: Acts as a precise calibration standard for analytical instrumentation to ensure accurate and reliable measurement results.

Basic Information

Product Name	Ciprofloxacin Related Compound CAS NO 528851-30-1
CAS No.	528851-30-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid related compound; Ciprofloxacin impurity; Ciprofloxacin specified impurity; Fluoroquinolone related substance; Ciprofloxacin analog; Antibiotic reference standard; Pharmaceutical secondary standard; CAS 528851-30-1
EINECS	Contact for details

Quality Control

Our Ciprofloxacin Related Compound is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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