Description

Ciprofloxacin-D8 Hydrochloride Hydrate (See Data Sheet) is a high-purity, deuterium-labeled internal standard essential for precise quantitative analysis in mass spectrometry. This stable isotope-labeled compound is critical for ensuring accuracy and reliability in bioanalytical studies, eliminating matrix effects and enabling robust pharmacokinetic and metabolic profiling. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in advanced method development and regulatory compliance work for the fluoroquinolone antibiotic class.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the analysis of ciprofloxacin in biological matrices (plasma, serum, urine, tissue).
• Pharmacokinetic & Bioavailability Studies: Enables accurate measurement of drug concentration-time profiles for ADME (Absorption, Distribution, Metabolism, Excretion) studies.
• Metabolite Identification & Profiling: Aids in the detection and quantification of ciprofloxacin metabolites in complex samples.
• Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Supports precise drug level monitoring in patient samples for clinical trials and personalized medicine approaches.
• Veterinary Drug Residue Analysis: Used in testing for ciprofloxacin residues in food-producing animals to ensure food safety compliance.
• Environmental Fate Studies: Applied in trace analysis of pharmaceutical pollutants in environmental water samples.

Basic Information

Product Name	Ciprofloxacin-D8 Hydrochloride Hydrate (See Data Sheet)
CAS No.	1216659-54-9
Molecular Formula	C17H10D8F N3O3 • HCl • xH2O
Molecular Weight	~ 385.8 (anhydrous free base)
Synonyms	1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid-d8 Hydrochloride Hydrate; 1-Cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydroquinoline-3-carboxylic Acid-d8 Hydrochloride Hydrate; Ciprofloxacin-d8 HCl Hydrate; [2H8]-Ciprofloxacin Hydrochloride Hydrate; Deuterated Ciprofloxacin HCl Hydrate; Cipro-d8 HCl Hydrate; Internal Standard for Ciprofloxacin
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin-D8 Hydrochloride Hydrate is manufactured and analyzed under strict quality systems. We guarantee high chemical purity and isotopic enrichment suitable for sensitive analytical applications. Certificates of Analysis (COA) are provided with each shipment, detailing key parameters such as assay (HPLC), isotopic purity (NMR/MS), residual solvents, and water content (KF). Our quality commitment supports compliance with cGMP principles for advanced pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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