Description

Ciprofloxacin-Acyl-β-D-Glucuronide is a crucial metabolite and reference standard used for analytical and research purposes. This compound is essential for the accurate quantification and metabolic profiling of the widely used fluoroquinolone antibiotic, ciprofloxacin, in biological matrices. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration and validation of analytical methods in drug development and quality control.
• Metabolite Identification & Quantification: Used as an analytical standard in LC-MS/MS and HPLC assays to identify and quantify the acyl glucuronide metabolite of ciprofloxacin in plasma, urine, and tissue samples.
• DMPK & Toxicology Studies: Critical for conducting absorption, distribution, metabolism, and excretion (ADME) studies and assessing the metabolic pathways and potential toxicity of ciprofloxacin.
• Bioanalytical Method Development: Employed to develop and optimize robust, sensitive, and specific analytical methods for compliance with FDA, EMA, and ICH guidelines.
• Clinical Research: Supports clinical trials by enabling precise monitoring of drug metabolite levels in patient samples for pharmacokinetic analysis.
• Impurity Profiling: Acts as a known impurity standard to monitor and control the quality of ciprofloxacin active pharmaceutical ingredient (API) and finished drug products.

Basic Information

Product Name	Ciprofloxacin-Acyl-β-D-Glucuronide
CAS No.	172040-93-6
Molecular Formula	C27H31FN4O10
Molecular Weight	590.56 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid Acyl-β-D-Glucuronide; Ciprofloxacin Acyl Glucuronide; Ciprofloxacin 1-O-β-Acylglucuronide; Ciprofloxacin Glucuronide Metabolite; Bay q 3939 Acyl Glucuronide; (1R,2S,3S,4R,5S)-4,5,6-Trihydroxy-2-[(1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carbonyl)oxy]oxane-3-carboxylic acid
EINECS	Contact for details

Quality Control

Our Ciprofloxacin-Acyl-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, identity, and impurities. We support compliance with ICH Q7 and GMP guidelines for active pharmaceutical ingredients (APIs) and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be handled under dry, inert conditions to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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